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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004886-26 | EudraCT Number | ||
| CRTH258A2302 | Other Identifier | Novartis Pharmaceuticals |
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The purpose of this study is to compare brolucizumab (RTH258) ophthalmic solution for intravitreal (IVT) injection (6 mg) to aflibercept ophthalmic solution for IVT injection (2 mg) in subjects with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye.
Subjects were randomized to brolucizumab 6 mg and aflibercept 2 mg in a 1:1 ratio. Subjects in both treatment arms received 3 monthly loading doses (Day 0, Week 4 and Week 8), followed by a maintenance regimen, until the end of the study (Week 96/Exit). All subjects attended pre-specified visits every 4 weeks.
Subjects in the brolucizumab 6 mg arm followed a q12w/q8w maintenance regimen. Within the q12w/q8w regimen, the initial treatment after the loading phase was q12w (1 injection every 12 weeks). If disease activity was identified by the masked investigator at any of the disease activity assessments, dosing was adjusted to q8w (1 injection every 8 weeks) ("q12w/q8w regimen"). Once subjects were adjusted to the q8w interval, they stayed on that interval until the end of the study.
Subjects in the aflibercept 2 mg arm followed a q8w maintenance regimen until the end of the study.
Results reported up to Week 48 are based on the database locked for the primary analysis at Week 48. Results reported after Week 48 are based on the database locked at the end of study (final analysis).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brolucizumab 6 mg | Experimental | Single intravitreal (IVT) injection of brolucizumab at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit |
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| Aflibercept 2 mg | Active Comparator | Single IVT injection of aflibercept ophthalmic solution at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brolucizumab ophthalmic solution | Drug | Ophthalmic solution for IVT injection administered as a 6 mg/50 µL dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) (Letters Read) at Week 48 - Study Eye | BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. | Baseline, Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Change From Baseline in BCVA (Letters Read) Over the Period Week 36 Through Week 48 - Study Eye | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. For each subject, this endpoint was defined as the average of the changes from baseline to Weeks 36, 40, 44, and 48. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Group Trial Lead | Novartis Pharmaceuticals | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39033924 | Derived | Khanani AM, Sadda SR, Sarraf D, Tadayoni R, Wong DT, Kempf AS, Saffar I, Gedif K, Chang A. Effect of Brolucizumab and Aflibercept on the Maximum Thickness of Pigment Epithelial Detachments and Sub-Retinal Pigment Epithelium Fluid in HAWK and HARRIER. Ophthalmol Retina. 2025 Jan;9(1):13-21. doi: 10.1016/j.oret.2024.07.012. Epub 2024 Jul 19. | |
| 34968756 |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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Of the 1048 subjects enrolled in the study, 305 were exited prior to randomization as screen failures. This reporting group includes all randomized subjects.
Subjects were recruited from investigative sites located in Austria, Belgium, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, South Korea, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Turkey, UK, and Vietnam.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brolucizumab 6 mg | Single intravitreal (IVT) injection of brolucizumab at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit |
| FG001 | Aflibercept 2 mg | Single IVT injection of aflibercept at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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This analysis population includes all randomized subjects who received at least 1 IVT injection of study treatment (Full Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | Brolucizumab 6 mg | Single intravitreal (IVT) injection of brolucizumab at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit |
| BG001 | Aflibercept 2 mg |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Best Corrected Visual Acuity (BCVA) (Letters Read) at Week 48 - Study Eye | BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. | Full Analysis Set (FAS) - Last Observation Carried Forward (LOCF) | Posted | Mean | Standard Deviation | letters | Baseline, Week 48 |
|
First treatment through study completion, an average of 96 weeks.
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brolucizumab 6mg | All subjects exposed to brolucizumab ophthalmic solution administered as a 6 mg/50 microliter (μL) dose |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract - Fellow eye | Eye disorders | MedDRA (20.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 1-862-778-8300 | novartis.email@novartis.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 10, 2017 | Jan 7, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 19, 2017 | Jan 24, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
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| ID | Term |
|---|---|
| C000622091 | brolucizumab |
| C533178 | aflibercept |
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| Aflibercept ophthalmic solution | Drug | Ophthalmic solution for IVT injection administered as a 2 mg/50 µL dose |
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| Baseline, Weeks 36, 40, 44, 48 |
| Proportion of Subjects With Positive q12 (Every 12 Weeks) Treatment Status at Week 48 | Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44) to identify q8w (one injection every 8 weeks) need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified. | Weeks 16, 20, 28, 32, 40, 44, 48 |
| Proportion of Subjects With Positive q12 Treatment Status at Week 48 Within the Subjects With no q8 (Every 8 Weeks) Treatment Need During the Initial q12w Cycle (Week 16, Week 20) | Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified. | Weeks 16, 20, 28, 32, 40, 44, 48 |
| Proportion of Subjects With Positive q12 Treatment Status up to Week 96 | Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified. | Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92, 96 |
| Proportion of Subjects With Positive q12 Treatment Status at Week 96 Within the Subjects With no q8 Treatment Need During the Initial q12w Cycle (Week 16, Week 20) | Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified. | Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92, 96 |
| Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
| Average Change From Baseline in BCVA (Letters Read) Over the Period Week 4 to Week 48/96 - Study Eye | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
| Average Change From Baseline in BCVA (Letters Read) Over the Period Week 12 to Week 48/96 - Study Eye | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. | Baseline, Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
| Average Change From Baseline in BCVA (Letters Read) Over the Period Week 84 to Week 96 - Study Eye | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. | Baseline, Weeks 84, 88, 92, 96 |
| Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
| Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
| Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
| Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
| Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
| Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
| Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly (0-100 letters). A score of 65 to 70 letters represents a low to moderate visual acuity. Baseline was defined as the last measurement prior to first treatment. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
| Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using Spectral-Domain Optical Coherence Tomography (SD-OCT), a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis. | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
| Average Change From Baseline in CSFT Over the Period Week 36 Through Week 48 - Study Eye | CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis. | Baseline, Weeks 36, 40, 44, 48 |
| Average Change From Baseline in CSFT Over the Period Week 84 Through Week 96 - Study Eye | CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis. | Baseline, Weeks 84, 88, 92, 96 |
| Average Change From Baseline in CSFT Over the Period Week 4 Through Week 48/96 - Study Eye | CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis. | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
| Change From Baseline in Choroidal Neovascularization (CNV) Lesion Size at Week 12, Week 48, and Week 96 - Study Eye | CNV lesion size (the area of new blood vessels in the choroid layer of the retina) size was measured using fluorescein angiography (FA). A negative change value indicates a reduction in lesion size, whereas a positive change value indicates an increase. An increase in CNV lesion size may indicate progression of the underlying disease. Only one eye (study eye) contributed to the analysis. | Baseline, Weeks 12, 48, 96 |
| Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | CSFTns was assessed using SD-OCT. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis. | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
| Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Subretinal fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal fluid is an indicator of underlying disease. One eye (study eye) contributed to the analysis. | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
| Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Intraretinal fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of intraretinal fluid is an indicator of underlying disease. One eye (study eye) contributed to the analysis. | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
| Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Sub-retinal pigment epithelium (RPE) fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of sub-RPE fluid is an indicator of underlying disease. One eye (study eye) contributed to the analysis. | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
| Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Subretinal fluid and intraretinal fluid were assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal and/or intraretinal fluid is an indicator of underlying disease. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
| Percentage of Subjects With Disease Activity Present (q8 Treatment Need = "Yes") at Week 16 - Study Eye | A disease activity assessment (DAA) was performed to identify q8 treatment need. 95% confidence interval (CI) for binomial proportions is based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. Hypothesis testing not pre-specified. | Week 16 |
| Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Score at Week 24, Week 48, Week 72, and Week 96 | The National Eye Institute Visual Function Questionnaire-25 (VFQ-25) is a validated questionnaire that collects 25 vision-targeted responses from AMD subjects. The 25 questions pertain to global vision rating (1), difficulty with near vision activities (3), difficulty with distance vision activities (3), limitations in social functioning due to vision (2), role limitations due to vision (2), dependency on others due to vision (3), mental health symptoms due to vision (4), driving difficulties (3), limitations with peripheral (1) and color vision (1), and ocular pain (2). Each response is converted to a 0 to 100 sub-scale, with the lowest and highest possible scores set at 0 and 100 points, respectively. The overall composite score (0 to 100) is obtained by averaging the 25 sub-scale scores. A high score represents better functioning. | Baseline, Weeks 24, 48, 72, 96 |
| Percentage of Subjects With Induced or Boosted Anti-drug Antibody (ADA) Status at Week 48 (Brolucizumab Only) | Serum samples were collected and assessed for anti-drug antibody status. Subjects were categorized as ADA negative when one of the following was met: ADA negative at all time points (predose and postdose); ADA negative at predose and no titer values above 10 at all other time points; or ADA titer of 10 at predose but negative at all other time points. ADA induced was defined as ADA negative at predose with postdose titer value greater than or equal to a titer of 30 at any timepoint. ADA boosted was defined as ADA positive at predose with postdose titer values that increased by at least two dilutions (9-fold) from their respective predose value at any time point. | Week 48 |
| Percentage of Subjects With Intraretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye | Intraretinal hemorrhage was assessed using SD-OCT and recorded as Present/Absent. The presence of intraretinal hemorrhage is an indicator of underlying disease. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. | Baseline, Weeks 12, 48, 96 |
| Percentage of Subjects With Subretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye | Subretinal hemorrhage was assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal hemorrhage is an indicator of underlying disease. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. | Baseline, Weeks 12, 48, 96 |
| Singh RP, Jhaveri C, Wykoff CC, Gale RP, Staurenghi G, Iida T, Koh A, B G, Gedif K, Singer M. Efficacy Outcomes of Brolucizumab Versus Aflibercept in Neovascular Age-Related Macular Degeneration Patients with Early Residual Fluid. Ophthalmol Retina. 2022 May;6(5):377-386. doi: 10.1016/j.oret.2021.12.014. Epub 2021 Dec 27. |
| 33207259 | Derived | Mones J, Srivastava SK, Jaffe GJ, Tadayoni R, Albini TA, Kaiser PK, Holz FG, Korobelnik JF, Kim IK, Pruente C, Murray TG, Heier JS. Risk of Inflammation, Retinal Vasculitis, and Retinal Occlusion-Related Events with Brolucizumab: Post Hoc Review of HAWK and HARRIER. Ophthalmology. 2021 Jul;128(7):1050-1059. doi: 10.1016/j.ophtha.2020.11.011. Epub 2020 Nov 15. |
| 30986442 | Derived | Dugel PU, Koh A, Ogura Y, Jaffe GJ, Schmidt-Erfurth U, Brown DM, Gomes AV, Warburton J, Weichselberger A, Holz FG; HAWK and HARRIER Study Investigators. HAWK and HARRIER: Phase 3, Multicenter, Randomized, Double-Masked Trials of Brolucizumab for Neovascular Age-Related Macular Degeneration. Ophthalmology. 2020 Jan;127(1):72-84. doi: 10.1016/j.ophtha.2019.04.017. Epub 2019 Apr 12. |
| Physician Decision |
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| Withdrawal by Subject |
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| Death |
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| Lost to Follow-up |
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| Other |
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Single IVT injection of aflibercept at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
| BG002 | Total | Total of all reporting groups |
| years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Best Corrected Visual Acuity (BCVA) (letters read) | BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. | Mean | Standard Deviation | letters |
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| Aflibercept 2 mg |
Single IVT injection of aflibercept at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
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| Secondary | Average Change From Baseline in BCVA (Letters Read) Over the Period Week 36 Through Week 48 - Study Eye | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. For each subject, this endpoint was defined as the average of the changes from baseline to Weeks 36, 40, 44, and 48. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. | FAS - LOCF | Posted | Mean | Standard Deviation | letters | Baseline, Weeks 36, 40, 44, 48 |
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| Secondary | Proportion of Subjects With Positive q12 (Every 12 Weeks) Treatment Status at Week 48 | Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44) to identify q8w (one injection every 8 weeks) need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified. | FAS - efficacy/safety approach | Posted | Number | 95% Confidence Interval | proportion of subjects | Weeks 16, 20, 28, 32, 40, 44, 48 |
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| Secondary | Proportion of Subjects With Positive q12 Treatment Status at Week 48 Within the Subjects With no q8 (Every 8 Weeks) Treatment Need During the Initial q12w Cycle (Week 16, Week 20) | Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified. | FAS - efficacy/safety approach | Posted | Number | 95% Confidence Interval | proportion of subjects | Weeks 16, 20, 28, 32, 40, 44, 48 |
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| Secondary | Proportion of Subjects With Positive q12 Treatment Status up to Week 96 | Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified. | FAS - efficacy/safety approach | Posted | Number | 95% Confidence Interval | proportion of subjects | Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92, 96 |
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| Secondary | Proportion of Subjects With Positive q12 Treatment Status at Week 96 Within the Subjects With no q8 Treatment Need During the Initial q12w Cycle (Week 16, Week 20) | Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified. | FAS - efficacy/safety approach | Posted | Number | 95% Confidence Interval | proportion of subjects | Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92, 96 |
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| Secondary | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. | FAS - LOCF | Posted | Mean | Standard Deviation | letters | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
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| Secondary | Average Change From Baseline in BCVA (Letters Read) Over the Period Week 4 to Week 48/96 - Study Eye | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. | FAS - LOCF | Posted | Mean | Standard Deviation | letters | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
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| Secondary | Average Change From Baseline in BCVA (Letters Read) Over the Period Week 12 to Week 48/96 - Study Eye | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. | FAS - LOCF | Posted | Mean | Standard Deviation | letters | Baseline, Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
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| Secondary | Average Change From Baseline in BCVA (Letters Read) Over the Period Week 84 to Week 96 - Study Eye | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. | FAS - LOCF | Posted | Mean | Standard Deviation | letters | Baseline, Weeks 84, 88, 92, 96 |
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| Secondary | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. | FAS - LOCF | Posted | Number | 95% Confidence Interval | percentage of subjects | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
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| Secondary | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. | FAS - LOCF | Posted | Number | 95% Confidence Interval | percentage of subjects | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
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| Secondary | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. | FAS - LOCF | Posted | Number | 95% Confidence Interval | percentage of subjects | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
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| Secondary | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. | FAS - LOCF | Posted | Number | 95% Confidence Interval | percentage of subjects | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
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| Secondary | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. | FAS - LOCF | Posted | Number | 95% Confidence Interval | percentage of subjects | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
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| Secondary | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. | FAS - LOCF | Posted | Number | 95% Confidence Interval | percentage of subjects | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
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| Secondary | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly (0-100 letters). A score of 65 to 70 letters represents a low to moderate visual acuity. Baseline was defined as the last measurement prior to first treatment. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. | FAS - LOCF | Posted | Number | 95% Confidence Interval | percentage of subjects | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
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| Secondary | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using Spectral-Domain Optical Coherence Tomography (SD-OCT), a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis. | FAS - LOCF | Posted | Mean | Standard Deviation | micrometers | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
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| Secondary | Average Change From Baseline in CSFT Over the Period Week 36 Through Week 48 - Study Eye | CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis. | FAS - LOCF | Posted | Mean | Standard Deviation | micrometers | Baseline, Weeks 36, 40, 44, 48 |
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| Secondary | Average Change From Baseline in CSFT Over the Period Week 84 Through Week 96 - Study Eye | CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis. | FAS - LOCF | Posted | Mean | Standard Deviation | micrometers | Baseline, Weeks 84, 88, 92, 96 |
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| Secondary | Average Change From Baseline in CSFT Over the Period Week 4 Through Week 48/96 - Study Eye | CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis. | FAS - LOCF | Posted | Mean | Standard Deviation | micrometers | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
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| Secondary | Change From Baseline in Choroidal Neovascularization (CNV) Lesion Size at Week 12, Week 48, and Week 96 - Study Eye | CNV lesion size (the area of new blood vessels in the choroid layer of the retina) size was measured using fluorescein angiography (FA). A negative change value indicates a reduction in lesion size, whereas a positive change value indicates an increase. An increase in CNV lesion size may indicate progression of the underlying disease. Only one eye (study eye) contributed to the analysis. | FAS - LOCF | Posted | Mean | Standard Deviation | millimeters squared | Baseline, Weeks 12, 48, 96 |
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| Secondary | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | CSFTns was assessed using SD-OCT. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis. | FAS - LOCF | Posted | Mean | Standard Deviation | micrometers | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
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| Secondary | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Subretinal fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal fluid is an indicator of underlying disease. One eye (study eye) contributed to the analysis. | FAS - LOCF | Posted | Number | 95% Confidence Interval | percentage of subjects | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
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| Secondary | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Intraretinal fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of intraretinal fluid is an indicator of underlying disease. One eye (study eye) contributed to the analysis. | FAS - LOCF | Posted | Number | 95% Confidence Interval | percentage of subjects | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
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| Secondary | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Sub-retinal pigment epithelium (RPE) fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of sub-RPE fluid is an indicator of underlying disease. One eye (study eye) contributed to the analysis. | FAS - LOCF | Posted | Number | 95% Confidence Interval | percentage of subjects | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
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| Secondary | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Subretinal fluid and intraretinal fluid were assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal and/or intraretinal fluid is an indicator of underlying disease. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. | FAS - LOCF | Posted | Number | 95% Confidence Interval | percentage of subjects | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
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| Secondary | Percentage of Subjects With Disease Activity Present (q8 Treatment Need = "Yes") at Week 16 - Study Eye | A disease activity assessment (DAA) was performed to identify q8 treatment need. 95% confidence interval (CI) for binomial proportions is based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. Hypothesis testing not pre-specified. | FAS - 'efficacy/safety' approach. Censored data attributable to lack of efficacy and/or safety are imputed with q8w need = Yes at the next disease activity assessment visit. | Posted | Number | 95% Confidence Interval | percentage of subjects | Week 16 |
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| Secondary | Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Score at Week 24, Week 48, Week 72, and Week 96 | The National Eye Institute Visual Function Questionnaire-25 (VFQ-25) is a validated questionnaire that collects 25 vision-targeted responses from AMD subjects. The 25 questions pertain to global vision rating (1), difficulty with near vision activities (3), difficulty with distance vision activities (3), limitations in social functioning due to vision (2), role limitations due to vision (2), dependency on others due to vision (3), mental health symptoms due to vision (4), driving difficulties (3), limitations with peripheral (1) and color vision (1), and ocular pain (2). Each response is converted to a 0 to 100 sub-scale, with the lowest and highest possible scores set at 0 and 100 points, respectively. The overall composite score (0 to 100) is obtained by averaging the 25 sub-scale scores. A high score represents better functioning. | FAS - Observed. Number analyzed is the number of subjects with a value for both baseline and the specific post-baseline visit. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 24, 48, 72, 96 |
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| Secondary | Percentage of Subjects With Induced or Boosted Anti-drug Antibody (ADA) Status at Week 48 (Brolucizumab Only) | Serum samples were collected and assessed for anti-drug antibody status. Subjects were categorized as ADA negative when one of the following was met: ADA negative at all time points (predose and postdose); ADA negative at predose and no titer values above 10 at all other time points; or ADA titer of 10 at predose but negative at all other time points. ADA induced was defined as ADA negative at predose with postdose titer value greater than or equal to a titer of 30 at any timepoint. ADA boosted was defined as ADA positive at predose with postdose titer values that increased by at least two dilutions (9-fold) from their respective predose value at any time point. | Safety Analysis Set - Observed | Posted | Number | percentage of subjects | Week 48 |
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| Secondary | Percentage of Subjects With Intraretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye | Intraretinal hemorrhage was assessed using SD-OCT and recorded as Present/Absent. The presence of intraretinal hemorrhage is an indicator of underlying disease. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. | FAS with non-missing values. Number Analyzed represents the number of subjects with a value for both baseline and the specific post-baseline visit. | Posted | Number | percentage of subjects | Baseline, Weeks 12, 48, 96 |
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| Secondary | Percentage of Subjects With Subretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye | Subretinal hemorrhage was assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal hemorrhage is an indicator of underlying disease. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. | FAS with non-missing values. Number Analyzed represents the number of subjects with a value for both baseline and the specific post-baseline visit. | Posted | Number | percentage of subjects | Baseline, Weeks 12, 48, 96 |
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| 4 |
| 370 |
| 79 |
| 370 |
| 176 |
| 370 |
| EG001 | Aflibercept 2mg | All subjects exposed to aflibercept ophthalmic solution administered as a 2 mg/50 μL dose | 7 | 369 | 89 | 369 | 194 | 369 |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
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| Atrioventricular block first degree | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
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| Bundle branch block left | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
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| Bundle branch block right | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
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| Cardiopulmonary failure | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
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| Parasystole | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA (20.1) | Systematic Assessment |
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| Anterior chamber inflammation - Study eye | Eye disorders | MedDRA (20.1) | Systematic Assessment |
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| Blindness - Study eye | Eye disorders | MedDRA (20.1) | Systematic Assessment |
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| Dry age-related macular degeneration - Study eye | Eye disorders | MedDRA (20.1) | Systematic Assessment |
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| Retinal artery embolism - Study eye | Eye disorders | MedDRA (20.1) | Systematic Assessment |
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| Retinal artery occlusion - Study eye | Eye disorders | MedDRA (20.1) | Systematic Assessment |
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| Retinal artery thrombosis - Study eye | Eye disorders | MedDRA (20.1) | Systematic Assessment |
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| Retinal detachment - Study eye | Eye disorders | MedDRA (20.1) | Systematic Assessment |
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| Retinal pigment epithelial tear - Study eye | Eye disorders | MedDRA (20.1) | Systematic Assessment |
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| Retinal tear - Study eye | Eye disorders | MedDRA (20.1) | Systematic Assessment |
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| Uveitis - Study eye | Eye disorders | MedDRA (20.1) | Systematic Assessment |
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| Visual acuity reduced - Study eye | Eye disorders | MedDRA (20.1) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Duodenitis haemorrhagic | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Intestinal polyp | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Large intestine perforation | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Lumbar hernia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Rectal prolapse | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Cyst | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Death | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Bile duct stone | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
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| Biliary colic | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
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| Drug-induced liver injury | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
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| Allergy to arthropod sting | Immune system disorders | MedDRA (20.1) | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Dacryocystitis - Study eye | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Endophthalmitis - Study eye | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Intervertebral discitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Cataract traumatic - Study eye | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Chest injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Limb traumatic amputation | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Investigation | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
|
| Breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
|
| Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
|
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
|
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
|
| Gastrointestinal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
|
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
|
| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
|
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
|
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
|
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
|
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
|
| Thyroid adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Cerebrovascular disorder | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Myasthenia gravis | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Radiculopathy | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Charles Bonnet syndrome | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
|
| Mental fatigue | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
|
| Mood disorder due to a general medical condition | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
|
| Paranoid personality disorder | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
|
| Acute prerenal failure | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
|
| Urinary bladder polyp | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
|
| Urinary bladder rupture | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
|
| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Neuropathic ulcer | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Hip surgery | Surgical and medical procedures | MedDRA (20.1) | Systematic Assessment |
|
| Implantable defibrillator replacement | Surgical and medical procedures | MedDRA (20.1) | Systematic Assessment |
|
| Varicose vein operation | Surgical and medical procedures | MedDRA (20.1) | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
| Peripheral ischaemia | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
| Varicose vein | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
| Cataract - Study eye | Eye disorders | MedDRA (20.1) | Systematic Assessment |
|
| Conjunctival haemorrhage - Study eye | Eye disorders | MedDRA (20.1) | Systematic Assessment |
|
| Eye pain - Study eye | Eye disorders | MedDRA (20.1) | Systematic Assessment |
|
| Neovascular age-related macular degeneration - Fellow eye | Eye disorders | MedDRA (20.1) | Systematic Assessment |
|
| Visual acuity reduced - Study eye | Eye disorders | MedDRA (20.1) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| D008679 |
| Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
The non-inferiority margin was 4 letters.
| Change from baseline at Week 12 |
|
| Change from baseline at Week 16 |
|
| Change from baseline at Week 20 |
|
| Change from baseline at Week 24 |
|
| Change from baseline at Week 28 |
|
| Change from baseline at Week 32 |
|
| Change from baseline at Week 36 |
|
| Change from baseline at Week 40 |
|
| Change from baseline at Week 44 |
|
| Change from baseline at Week 48 |
|
| Change from baseline at Week 52 |
|
| Change from baseline at Week 56 |
|
| Change from baseline at Week 60 |
|
| Change from baseline at Week 64 |
|
| Change from baseline at Week 68 |
|
| Change from baseline at Week 72 |
|
| Change from baseline at Week 76 |
|
| Change from baseline at Week 80 |
|
| Change from baseline at Week 84 |
|
| Change from baseline at Week 88 |
|
| Change from baseline at Week 92 |
|
| Change from baseline at Week 96 |
|
| Week 8 | ANOVA | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -1.0 | Standard Error of the Mean | 0.63 | 2-Sided | 95 | -2.2 | 0.2 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 12 | ANOVA | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -1.0 | Standard Error of the Mean | 0.71 | 2-Sided | 95 | -2.4 | 0.4 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 16 | ANOVA | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -0.9 | Standard Error of the Mean | 0.73 | 2-Sided | 95 | -2.3 | 0.6 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 20 | ANOVA | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -1.5 | Standard Error of the Mean | 0.76 | 2-Sided | 95 | -3.0 | 0.0 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 24 | ANOVA | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -0.9 | Standard Error of the Mean | 0.79 | 2-Sided | 95 | -2.5 | 0.6 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 28 | ANOVA | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -1.1 | Standard Error of the Mean | 0.82 | 2-Sided | 95 | -2.7 | 0.5 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 32 | ANOVA | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -0.9 | Standard Error of the Mean | 0.81 | 2-Sided | 95 | -2.5 | 0.7 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 36 | ANOVA | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -1.2 | Standard Error of the Mean | 0.84 | 2-Sided | 95 | -2.9 | 0.4 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 40 | ANOVA | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -1.2 | Standard Error of the Mean | 0.85 | 2-Sided | 95 | -2.9 | 0.5 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 44 | ANOVA | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -1.6 | Standard Error of the Mean | 0.86 | 2-Sided | 95 | -3.2 | 0.1 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 48 | ANOVA | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -0.7 | Standard Error of the Mean | 0.86 | 2-Sided | 95 | -2.4 | 1.0 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 52 | ANOVA | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -0.7 | Standard Error of the Mean | 0.90 | 2-Sided | 95 | -2.5 | 1.1 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 56 | ANOVA | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -0.7 | Standard Error of the Mean | 0.92 | 2-Sided | 95 | -2.5 | 1.1 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 60 | ANOVA | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -0.8 | Standard Error of the Mean | 0.93 | 2-Sided | 95 | -2.7 | 1.0 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 64 | ANOVA | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -0.7 | Standard Error of the Mean | 0.95 | 2-Sided | 95 | -2.5 | 1.2 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 68 | ANOVA | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -0.7 | Standard Error of the Mean | 0.96 | 2-Sided | 95 | -2.5 | 1.2 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 72 | ANOVA | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -0.9 | Standard Error of the Mean | 0.98 | 2-Sided | 95 | -2.8 | 1.1 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 76 | ANOVA | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -0.5 | Standard Error of the Mean | 0.98 | 2-Sided | 95 | -2.5 | 1.4 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 80 | ANOVA | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -0.2 | Standard Error of the Mean | 0.99 | 2-Sided | 95 | -2.1 | 1.8 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 84 | ANOVA | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -0.9 | Standard Error of the Mean | 1.00 | 2-Sided | 95 | -2.9 | 1.1 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 88 | ANOVA | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -0.6 | Standard Error of the Mean | 0.99 | 2-Sided | 95 | -2.6 | 1.3 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 92 | ANOVA | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -0.4 | Standard Error of the Mean | 1.02 | 2-Sided | 95 | -2.4 | 1.6 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 96 | ANOVA | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -0.4 | Standard Error of the Mean | 1.04 | 2-Sided | 95 | -2.5 | 1.6 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 4 to Week 96 | ANOVA | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -0.8 | Standard Error of the Mean | 0.78 | 2-Sided | 95 | -2.4 | 0.7 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 12 to Week 96 | ANOVA | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -0.8 | Standard Error of the Mean | 0.82 | 2-Sided | 95 | -2.4 | 0.8 | Other | Treatment difference | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
| Change from baseline at Week 12 |
|
| Change from baseline at Week 16 |
|
| Change from baseline at Week 20 |
|
| Change from baseline at Week 24 |
|
| Change from baseline at Week 28 |
|
| Change from baseline at Week 32 |
|
| Change from baseline at Week 36 |
|
| Change from baseline at Week 40 |
|
| Change from baseline at Week 44 |
|
| Change from baseline at Week 48 |
|
| Change from baseline at Week 52 |
|
| Change from baseline at Week 56 |
|
| Change from baseline at Week 60 |
|
| Change from baseline at Week 64 |
|
| Change from baseline at Week 68 |
|
| Change from baseline at Week 72 |
|
| Change from baseline at Week 76 |
|
| Change from baseline at Week 80 |
|
| Change from baseline at Week 84 |
|
| Change from baseline at Week 88 |
|
| Change from baseline at Week 92 |
|
| Change from baseline at Week 96 |
|
| Week 8 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -4.3 | 2-Sided | 95 | -9.5 | 1.0 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 12 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -5.0 | 2-Sided | 95 | -10.5 | 0.3 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 16 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -2.3 | 2-Sided | 95 | -8.4 | 3.7 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 20 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -3.1 | 2-Sided | 95 | -8.8 | 2.8 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 24 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.9 | 2-Sided | 95 | -5.2 | 6.7 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 28 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -3.7 | 2-Sided | 95 | -9.9 | 2.3 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 32 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -3.6 | 2-Sided | 95 | -10.5 | 2.7 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 36 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -4.9 | 2-Sided | 95 | -11.6 | 1.3 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 40 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -4.7 | 2-Sided | 95 | -11.5 | 1.9 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 44 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -4.6 | 2-Sided | 95 | -11.3 | 1.8 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 48 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.6 | 2-Sided | 95 | -7.1 | 5.8 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 52 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.6 | 2-Sided | 95 | -7.0 | 5.5 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 56 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.1 | 2-Sided | 95 | -7.7 | 5.4 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 60 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -2.2 | 2-Sided | 95 | -8.3 | 4.2 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 64 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.4 | 2-Sided | 95 | -7.9 | 5.4 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 68 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -3.5 | 2-Sided | 95 | -9.9 | 3.1 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 72 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -4.1 | 2-Sided | 95 | -10.2 | 2.3 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 76 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -2.4 | 2-Sided | 95 | -8.8 | 4.0 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 80 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -2.6 | 2-Sided | 95 | -9.0 | 3.5 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 84 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -3.8 | 2-Sided | 95 | -9.9 | 2.8 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 88 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -5.8 | 2-Sided | 95 | -11.8 | 0.3 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 92 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.7 | 2-Sided | 95 | -7.9 | 4.5 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 96 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -2.4 | 2-Sided | 95 | -8.8 | 4.1 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Change from baseline at Week 12 |
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| Change from baseline at Week 16 |
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| Change from baseline at Week 20 |
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| Change from baseline at Week 24 |
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| Change from baseline at Week 28 |
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| Change from baseline at Week 32 |
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| Change from baseline at Week 36 |
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| Change from baseline at Week 40 |
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| Change from baseline at Week 44 |
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| Change from baseline at Week 48 |
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| Change from baseline at Week 52 |
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| Change from baseline at Week 56 |
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| Change from baseline at Week 60 |
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| Change from baseline at Week 64 |
|
| Change from baseline at Week 68 |
|
| Change from baseline at Week 72 |
|
| Change from baseline at Week 76 |
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| Change from baseline at Week 80 |
|
| Change from baseline at Week 84 |
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| Change from baseline at Week 88 |
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| Change from baseline at Week 92 |
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| Change from baseline at Week 96 |
|
| Week 8 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -6.0 | 2-Sided | 95 | -13.0 | 0.1 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 12 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -3.8 | 2-Sided | 95 | -10.1 | 2.4 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 16 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.5 | 2-Sided | 95 | -7.3 | 6.3 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 20 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -4.6 | 2-Sided | 95 | -11.2 | 2.2 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 24 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -3.7 | 2-Sided | 95 | -10.7 | 3.0 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 28 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -2.4 | 2-Sided | 95 | -9.6 | 4.0 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 32 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -2.6 | 2-Sided | 95 | -9.4 | 4.5 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 36 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -5.4 | 2-Sided | 95 | -12.1 | 1.1 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 40 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -3.1 | 2-Sided | 95 | -9.9 | 3.5 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 44 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -3.0 | 2-Sided | 95 | -10.3 | 4.2 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 48 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.9 | 2-Sided | 95 | -8.7 | 4.7 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 52 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.3 | 2-Sided | 95 | -8.0 | 5.7 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 56 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -2.8 | 2-Sided | 95 | -9.8 | 4.3 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 60 | Regression, Logistic | Difference in proportions | -2.8 | 2-Sided | 95 | -9.6 | 4.2 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other | Hypothesis testing not pre-specified. |
| Week 64 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.7 | 2-Sided | 95 | -8.8 | 5.4 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 68 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.7 | 2-Sided | 95 | -8.4 | 5.0 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 72 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -3.6 | 2-Sided | 95 | -10.4 | 2.9 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 76 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.5 | 2-Sided | 95 | -6.5 | 7.2 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 80 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.7 | 2-Sided | 95 | -7.5 | 6.1 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 84 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -3.5 | 2-Sided | 95 | -10.4 | 3.1 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 88 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -2.5 | 2-Sided | 95 | -9.6 | 3.9 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 92 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 1.9 | 2-Sided | 95 | -5.0 | 8.3 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 96 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.1 | 2-Sided | 95 | -7.0 | 6.8 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Change from baseline at Week 12 |
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| Change from baseline at Week 16 |
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| Change from baseline at Week 20 |
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| Change from baseline at Week 24 |
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| Change from baseline at Week 28 |
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| Change from baseline at Week 32 |
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| Change from baseline at Week 36 |
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| Change from baseline at Week 40 |
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| Change from baseline at Week 44 |
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| Change from baseline at Week 48 |
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| Change from baseline at Week 52 |
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| Change from baseline at Week 56 |
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| Change from baseline at Week 60 |
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| Change from baseline at Week 64 |
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| Change from baseline at Week 68 |
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| Change from baseline at Week 72 |
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| Change from baseline at Week 76 |
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| Change from baseline at Week 80 |
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| Change from baseline at Week 84 |
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| Change from baseline at Week 88 |
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| Change from baseline at Week 92 |
|
| Change from baseline at Week 96 |
|
| Week 8 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -3.2 | 2-Sided | 95 | -10.2 | 3.7 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 12 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -3.7 | 2-Sided | 95 | -10.7 | 3.3 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 16 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.4 | 2-Sided | 95 | -8.4 | 5.7 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 20 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -5.3 | 2-Sided | 95 | -12.3 | 1.5 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 24 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -3.2 | 2-Sided | 95 | -9.9 | 3.7 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 28 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -5.9 | 2-Sided | 95 | -12.8 | 0.7 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 32 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.9 | 2-Sided | 95 | -8.2 | 4.8 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 36 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -2.3 | 2-Sided | 95 | -9.2 | 4.2 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 40 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.3 | 2-Sided | 95 | -8.2 | 5.6 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 44 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.5 | 2-Sided | 95 | -8.5 | 5.0 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 48 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.2 | 2-Sided | 95 | -7.4 | 6.2 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 52 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -2.7 | 2-Sided | 95 | -9.8 | 4.0 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 56 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.7 | 2-Sided | 95 | -8.6 | 4.8 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 60 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.7 | 2-Sided | 95 | -7.8 | 6.1 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 64 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 2.3 | 2-Sided | 95 | -4.5 | 9.2 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 68 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.5 | 2-Sided | 95 | -8.6 | 4.9 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 72 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 1.1 | 2-Sided | 95 | -5.8 | 7.5 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 76 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 2.0 | 2-Sided | 95 | -5.1 | 8.4 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 80 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 4.2 | 2-Sided | 95 | -2.8 | 10.9 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 84 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -2.7 | 2-Sided | 95 | -9.3 | 4.1 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 88 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.9 | 2-Sided | 95 | -6.1 | 7.7 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 92 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 3.7 | 2-Sided | 95 | -3.0 | 10.4 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 96 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 3.1 | 2-Sided | 95 | -3.9 | 10.0 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Change from baseline at Week 12 |
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| Change from baseline at Week 16 |
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| Change from baseline at Week 20 |
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| Change from baseline at Week 24 |
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| Change from baseline at Week 28 |
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| Change from baseline at Week 32 |
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| Change from baseline at Week 36 |
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| Change from baseline at Week 40 |
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| Change from baseline at Week 44 |
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| Change from baseline at Week 48 |
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| Change from baseline at Week 52 |
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| Change from baseline at Week 56 |
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| Change from baseline at Week 60 |
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| Change from baseline at Week 64 |
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| Change from baseline at Week 68 |
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| Change from baseline at Week 72 |
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| Change from baseline at Week 76 |
|
| Change from baseline at Week 80 |
|
| Change from baseline at Week 84 |
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| Change from baseline at Week 88 |
|
| Change from baseline at Week 92 |
|
| Change from baseline at Week 96 |
|
| Week 8 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.6 | 2-Sided | 95 | -2.3 | 1.1 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 12 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.0 | 2-Sided | 95 | -1.9 | 2.2 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2 mg) was estimated using a bootstrap method. | Other |
| Week 16 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.0 | 2-Sided | 95 | -2.1 | 2.3 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 20 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.6 | 2-Sided | 95 | -2.0 | 3.3 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 24 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.5 | 2-Sided | 95 | -3.0 | 2.2 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 28 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.5 | 2-Sided | 95 | -3.0 | 2.3 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 32 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.5 | 2-Sided | 95 | -3.2 | 2.5 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 36 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.4 | 2-Sided | 95 | -2.3 | 3.3 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 40 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 1.2 | 2-Sided | 95 | -1.7 | 4.6 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 44 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.1 | 2-Sided | 95 | -2.7 | 3.4 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 48 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.0 | 2-Sided | 95 | -3.9 | 2.2 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 52 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.0 | 2-Sided | 95 | -4.3 | 2.3 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 56 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.6 | 2-Sided | 95 | -2.8 | 3.9 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 60 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.6 | 2-Sided | 95 | -2.5 | 4.2 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 64 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.7 | 2-Sided | 95 | -2.7 | 4.5 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 68 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.9 | 2-Sided | 95 | -4.2 | 2.6 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 72 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.9 | 2-Sided | 95 | -2.5 | 4.5 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 76 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.7 | 2-Sided | 95 | -2.5 | 4.4 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 80 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.9 | 2-Sided | 95 | -2.4 | 4.6 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 84 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.2 | 2-Sided | 95 | -3.1 | 4.1 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 88 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.2 | 2-Sided | 95 | -3.5 | 3.6 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 92 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.4 | 2-Sided | 95 | -3.8 | 3.3 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 96 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.4 | 2-Sided | 95 | -3.8 | 3.3 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Change from baseline at Week 12 |
|
| Change from baseline at Week 16 |
|
| Change from baseline at Week 20 |
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| Change from baseline at Week 24 |
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| Change from baseline at Week 28 |
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| Change from baseline at Week 32 |
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| Change from baseline at Week 36 |
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| Change from baseline at Week 40 |
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| Change from baseline at Week 44 |
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| Change from baseline at Week 48 |
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| Change from baseline at Week 52 |
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| Change from baseline at Week 56 |
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| Change from baseline at Week 60 |
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| Change from baseline at Week 64 |
|
| Change from baseline at Week 68 |
|
| Change from baseline at Week 72 |
|
| Change from baseline at Week 76 |
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| Change from baseline at Week 80 |
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| Change from baseline at Week 84 |
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| Change from baseline at Week 88 |
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| Change from baseline at Week 92 |
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| Change from baseline at Week 96 |
|
| Week 8 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.0 | 2-Sided | 95 | -2.2 | 2.1 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 12 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.3 | 2-Sided | 95 | -2.8 | 2.2 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 16 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.4 | 2-Sided | 95 | -4.4 | 1.7 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 20 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 1.4 | 2-Sided | 95 | -1.7 | 4.9 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 24 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.7 | 2-Sided | 95 | -3.9 | 2.8 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 28 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.3 | 2-Sided | 95 | -3.2 | 3.8 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 32 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.1 | 2-Sided | 95 | -3.8 | 3.5 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 36 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.3 | 2-Sided | 95 | -3.0 | 4.2 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 40 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 1.2 | 2-Sided | 95 | -2.4 | 5.1 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 44 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 2.5 | 2-Sided | 95 | -1.1 | 6.5 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 48 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.4 | 2-Sided | 95 | -4.0 | 3.3 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 52 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.9 | 2-Sided | 95 | -2.8 | 4.7 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 56 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 1.2 | 2-Sided | 95 | -2.8 | 5.5 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 60 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference of proportions | 1.0 | 2-Sided | 95 | -2.6 | 4.7 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 64 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.1 | 2-Sided | 95 | -4.0 | 4.3 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 68 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.6 | 2-Sided | 95 | -4.2 | 3.6 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 72 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.1 | 2-Sided | 95 | -4.0 | 3.7 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 76 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.4 | 2-Sided | 95 | -3.5 | 4.7 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 80 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.7 | 2-Sided | 95 | -4.5 | 3.4 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 84 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.2 | 2-Sided | 95 | -3.6 | 4.5 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 88 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.7 | 2-Sided | 95 | -4.5 | 3.6 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 92 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.8 | 2-Sided | 95 | -5.7 | 2.6 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 96 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.0 | 2-Sided | 95 | -4.9 | 3.2 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Change from baseline at Week 12 |
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| Change from baseline at Week 16 |
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| Change from baseline at Week 20 |
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| Change from baseline at Week 24 |
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| Change from baseline at Week 28 |
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| Change from baseline at Week 32 |
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| Change from baseline at Week 36 |
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| Change from baseline at Week 40 |
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| Change from baseline at Week 44 |
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| Change from baseline at Week 48 |
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| Change from baseline at Week 52 |
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| Change from baseline at Week 56 |
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| Change from baseline at Week 60 |
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| Change from baseline at Week 64 |
|
| Change from baseline at Week 68 |
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| Change from baseline at Week 72 |
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| Change from baseline at Week 76 |
|
| Change from baseline at Week 80 |
|
| Change from baseline at Week 84 |
|
| Change from baseline at Week 88 |
|
| Change from baseline at Week 92 |
|
| Change from baseline at Week 96 |
|
| Week 8 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.5 | 2-Sided | 95 | -4.4 | 3.4 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 12 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.0 | 2-Sided | 95 | -5.0 | 3.1 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 16 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 1.9 | 2-Sided | 95 | -1.9 | 6.2 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 20 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 3.7 | 2-Sided | 95 | -0.4 | 7.8 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Number of subjects with >=5 letter loss from baseline in BCVA (letters read) at each post-baseline visit - Week 24 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 3.1 | 2-Sided | 95 | -1.3 | 7.8 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 28 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 2.6 | 2-Sided | 95 | -1.7 | 7.3 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 32 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 1.2 | 2-Sided | 95 | -3.2 | 5.9 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 36 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 3.4 | 2-Sided | 95 | -0.7 | 8.3 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 40 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 1.0 | 2-Sided | 95 | -3.8 | 5.6 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 44 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 2.9 | 2-Sided | 95 | -1.4 | 7.0 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 48 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.7 | 2-Sided | 95 | -5.1 | 3.7 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 52 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 2.1 | 2-Sided | 95 | -2.5 | 6.7 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 56 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 1.8 | 2-Sided | 95 | -2.8 | 6.4 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 60 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 1.2 | 2-Sided | 95 | -3.6 | 5.8 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 64 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.5 | 2-Sided | 95 | -4.0 | 5.4 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 68 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 1.8 | 2-Sided | 95 | -2.8 | 6.4 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 72 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.7 | 2-Sided | 95 | -4.3 | 5.7 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 76 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.7 | 2-Sided | 95 | -4.4 | 5.8 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 80 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.2 | 2-Sided | 95 | -6.0 | 3.6 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 84 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.4 | 2-Sided | 95 | -5.2 | 4.5 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 88 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.2 | 2-Sided | 95 | -5.7 | 3.6 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 92 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.5 | 2-Sided | 95 | -6.5 | 3.4 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 96 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.1 | 2-Sided | 95 | -5.1 | 4.8 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 8 |
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| Week 12 |
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| Week 16 |
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| Week 20 |
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| Week 24 |
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| Week 28 |
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| Week 32 |
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| Week 36 |
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| Week 40 |
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| Week 44 |
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| Week 48 |
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| Week 52 |
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| Week 56 |
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| Week 60 |
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| Week 64 |
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| Week 68 |
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| Week 72 |
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| Week 76 |
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| Week 80 |
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| Week 84 |
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| Week 88 |
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| Week 92 |
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| Week 96 |
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| Week 8 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -2.1 | 2-Sided | 95 | -8.1 | 3.7 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 12 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -2.5 | 2-Sided | 95 | -8.4 | 3.5 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 16 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.3 | 2-Sided | 95 | -5.4 | 6.7 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 20 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -2.2 | 2-Sided | 95 | -8.2 | 4.0 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 24 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -3.1 | 2-Sided | 95 | -9.0 | 3.3 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 28 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -3.2 | 2-Sided | 95 | -9.3 | 2.5 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 32 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -3.1 | 2-Sided | 95 | -9.6 | 2.8 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 36 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -3.7 | 2-Sided | 95 | -9.6 | 2.2 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 40 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.7 | 2-Sided | 95 | -7.6 | 4.2 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 44 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.4 | 2-Sided | 95 | -7.5 | 5.0 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 48 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.4 | 2-Sided | 95 | -5.4 | 6.1 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 52 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.8 | 2-Sided | 95 | -7.7 | 4.5 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 56 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.9 | 2-Sided | 95 | -7.7 | 4.0 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 60 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -4.7 | 2-Sided | 95 | -10.8 | 1.4 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 64 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -2.8 | 2-Sided | 95 | -8.9 | 3.2 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 68 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -3.1 | 2-Sided | 95 | -9.5 | 2.9 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 72 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.6 | 2-Sided | 95 | -7.9 | 4.5 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 76 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -2.0 | 2-Sided | 95 | -8.1 | 4.1 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 80 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.5 | 2-Sided | 95 | -5.6 | 6.6 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 84 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -2.4 | 2-Sided | 95 | -8.3 | 3.8 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 88 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.3 | 2-Sided | 95 | -7.4 | 4.5 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 92 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.5 | 2-Sided | 95 | -6.5 | 5.8 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 96 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -2.0 | 2-Sided | 95 | -8.1 | 4.1 | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Change from baseline at Week 12 |
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| Change from baseline at Week 16 |
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| Change from baseline at Week 20 |
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| Change from baseline at Week 24 |
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| Change from baseline at Week 28 |
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| Change from baseline at Week 32 |
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| Change from baseline at Week 36 |
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| Change from baseline at Week 40 |
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| Change from baseline at Week 44 |
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| Change from baseline at Week 48 |
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| Change from baseline at Week 52 |
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| Change from baseline at Week 56 |
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| Change from baseline at Week 60 |
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| Change from baseline at Week 64 |
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| Change from baseline at Week 68 |
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| Change from baseline at Week 72 |
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| Change from baseline at Week 76 |
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| Change from baseline at Week 80 |
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| Change from baseline at Week 84 |
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| Change from baseline at Week 88 |
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| Change from baseline at Week 92 |
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| Change from baseline at Week 96 |
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| Week 8 | ANOVA | Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -29.5 | Standard Error of the Mean | 8.18 | 2-Sided | 95 | -45.6 | -13.4 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 12 | ANOVA | Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -30.3 | Standard Error of the Mean | 8.45 | 2-Sided | 95 | -46.9 | -13.7 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 16 | ANOVA | Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -40.2 | Standard Error of the Mean | 9.51 | 2-Sided | 95 | -58.9 | -21.6 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 20 | ANOVA | Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -2.9 | Standard Error of the Mean | 9.12 | 2-Sided | 95 | -20.9 | 15.0 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 24 | ANOVA | Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -47.8 | Standard Error of the Mean | 9.42 | 2-Sided | 95 | -66.3 | -29.3 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 28 | ANOVA | Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -23.7 | Standard Error of the Mean | 9.34 | 2-Sided | 95 | -42.0 | -5.4 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 32 | ANOVA | Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -33.7 | Standard Error of the Mean | 9.54 | 2-Sided | 95 | -52.4 | -15.0 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 36 | ANOVA | Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -30.4 | Standard Error of the Mean | 8.94 | 2-Sided | 95 | -48.0 | -12.9 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 40 | ANOVA | Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -44.7 | Standard Error of the Mean | 9.57 | 2-Sided | 95 | -63.5 | -25.9 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 44 | ANOVA | Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -19.2 | Standard Error of the Mean | 9.24 | 2-Sided | 95 | -37.3 | -1.1 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 48 | ANOVA | Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -49.9 | Standard Error of the Mean | 9.68 | 2-Sided | 95 | -68.9 | -30.9 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 52 | ANOVA | Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -28.1 | Standard Error of the Mean | 9.01 | 2-Sided | 95 | -45.8 | -10.4 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 56 | ANOVA | Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -43.1 | Standard Error of the Mean | 9.86 | 2-Sided | 95 | -62.4 | -23.7 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 60 | ANOVA | Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -31.1 | Standard Error of the Mean | 9.34 | 2-Sided | 95 | -49.5 | -12.8 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 64 | ANOVA | Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -45.8 | Standard Error of the Mean | 9.70 | 2-Sided | 95 | -64.9 | -26.8 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 68 | ANOVA | Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -23.7 | Standard Error of the Mean | 9.31 | 2-Sided | 95 | -42.0 | -5.4 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 72 | ANOVA | Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -47.3 | Standard Error of the Mean | 9.69 | 2-Sided | 95 | -66.4 | -28.3 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 76 | ANOVA | Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -28.0 | Standard Error of the Mean | 9.43 | 2-Sided | 95 | -46.5 | -9.5 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 80 | ANOVA | Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -40.9 | Standard Error of the Mean | 9.94 | 2-Sided | 95 | -60.4 | -21.4 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 84 | ANOVA | Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -31.0 | Standard Error of the Mean | 9.48 | 2-Sided | 95 | -49.6 | -12.4 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 88 | ANOVA | Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -42.6 | Standard Error of the Mean | 9.84 | 2-Sided | 95 | -61.9 | -23.3 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 92 | ANOVA | Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -29.1 | Standard Error of the Mean | 9.56 | 2-Sided | 95 | -47.9 | -10.3 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 96 | ANOVA | Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -42.6 | Standard Error of the Mean | 9.87 | 2-Sided | 95 | -62.0 | -23.3 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 4 to Week 96 | ANOVA | Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -33.5 | Standard Error of the Mean | 8.84 | 2-Sided | 95 | -50.8 | -16.1 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Change from baseline at Week 96 |
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| Week 48 | ANOVA | Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | 0.3 | Standard Error of the Mean | 0.17 | 2-Sided | 95 | -0.1 | 0.6 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 96 | ANOVA | Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | 0.3 | Standard Error of the Mean | 0.16 | 2-Sided | 95 | 0.0 | 0.6 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Change from baseline at Week 12 |
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| Change from baseline at Week 16 |
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| Change from baseline at Week 20 |
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| Change from baseline at Week 24 |
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| Change from baseline at Week 28 |
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| Change from baseline at Week 32 |
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| Change from baseline at Week 36 |
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| Change from baseline at Week 40 |
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| Change from baseline at Week 44 |
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| Change from baseline at Week 48 |
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| Change from baseline at Week 52 |
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| Change from baseline at Week 56 |
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| Change from baseline at Week 60 |
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| Change from baseline at Week 64 |
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| Change from baseline at Week 68 |
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| Change from baseline at Week 72 |
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| Change from baseline at Week 76 |
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| Change from baseline at Week 80 |
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| Change from baseline at Week 84 |
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| Change from baseline at Week 88 |
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| Change from baseline at Week 92 |
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| Change from baseline at Week 96 |
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| Week 8 | ANOVA | Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -3.8 | Standard Error of the Mean | 4.98 | 2-Sided | 95 | -13.6 | 6.0 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 12 | ANOVA | Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -4.5 | Standard Error of the Mean | 4.98 | 2-Sided | 95 | -14.3 | 5.3 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 16 | ANOVA | Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -3.7 | Standard Error of the Mean | 5.12 | 2-Sided | 95 | -13.7 | 6.4 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 20 | ANOVA | Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | 4.6 | Standard Error of the Mean | 5.11 | 2-Sided | 95 | -5.5 | 14.6 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 24 | ANOVA | Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -5.8 | Standard Error of the Mean | 5.35 | 2-Sided | 95 | -16.3 | 4.7 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 28 | ANOVA | Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -3.1 | Standard Error of the Mean | 5.13 | 2-Sided | 95 | -13.1 | 7.0 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 32 | ANOVA | Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -2.0 | Standard Error of the Mean | 5.37 | 2-Sided | 95 | -12.6 | 8.5 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 36 | ANOVA | Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -5.0 | Standard Error of the Mean | 5.15 | 2-Sided | 95 | -15.2 | 5.1 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 40 | ANOVA | Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -6.6 | Standard Error of the Mean | 5.30 | 2-Sided | 95 | -17.0 | 3.8 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 44 | ANOVA | Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -2.8 | Standard Error of the Mean | 5.42 | 2-Sided | 95 | -13.4 | 7.9 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 48 | ANOVA | Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -7.0 | Standard Error of the Mean | 5.40 | 2-Sided | 95 | -17.6 | 3.7 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 52 | ANOVA | Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -2.7 | Standard Error of the Mean | 5.19 | 2-Sided | 95 | -12.9 | 7.5 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 56 | ANOVA | Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -5.0 | Standard Error of the Mean | 5.31 | 2-Sided | 95 | -15.4 | 5.4 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 60 | ANOVA | Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -4.2 | Standard Error of the Mean | 5.15 | 2-Sided | 95 | -14.3 | 5.9 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 64 | ANOVA | Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -3.9 | Standard Error of the Mean | 5.24 | 2-Sided | 95 | -14.2 | 6.4 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 68 | ANOVA | Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -0.6 | Standard Error of the Mean | 5.17 | 2-Sided | 95 | -10.7 | 9.6 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 72 | ANOVA | Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -4.6 | Standard Error of the Mean | 5.24 | 2-Sided | 95 | -14.8 | 5.7 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 76 | ANOVA | Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -2.8 | Standard Error of the Mean | 5.23 | 2-Sided | 95 | -13.1 | 7.4 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 80 | ANOVA | Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -3.7 | Standard Error of the Mean | 5.33 | 2-Sided | 95 | -14.1 | 6.8 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 84 | ANOVA | Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -3.1 | Standard Error of the Mean | 5.30 | 2-Sided | 95 | -13.5 | 7.3 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 88 | ANOVA | Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -4.0 | Standard Error of the Mean | 5.39 | 2-Sided | 95 | -14.6 | 6.5 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 92 | ANOVA | Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors. | Least Squares Mean Difference | -2.3 | Standard Error of the Mean | 5.25 | 2-Sided | 95 | -12.6 | 8.0 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 96 | ANOVA | Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors. | Hypothesis testing not pre-specified. | Least Squares Mean Difference | -3.0 | Standard Error of the Mean | 5.42 | 2-Sided | 95 | -13.6 | 7.7 | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) | Other | Treatment difference |
| Week 12 |
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| Week 16 |
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| Week 20 |
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| Week 24 |
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| Week 28 |
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| Week 32 |
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| Week 36 |
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| Week 40 |
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| Week 44 |
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| Week 48 |
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| Week 52 |
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| Week 56 |
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| Week 60 |
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| Week 64 |
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| Week 68 |
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| Week 72 |
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| Week 76 |
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| Week 80 |
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| Week 84 |
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| Week 88 |
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| Week 92 |
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| Week 96 |
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| Week 8 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -8.5 | 2-Sided | 95 | -13.8 | -3.0 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 12 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -6.9 | 2-Sided | 95 | -12.2 | -1.7 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 16 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -14.2 | 2-Sided | 95 | -20.8 | -8.3 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 20 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 3.1 | 2-Sided | 95 | -2.9 | 9.6 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 24 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -19.2 | 2-Sided | 95 | -25.5 | -13.0 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 28 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -5.9 | 2-Sided | 95 | -11.6 | -0.4 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 32 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -9.8 | 2-Sided | 95 | -16.5 | -3.5 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 36 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -8.0 | 2-Sided | 95 | -13.6 | -2.5 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 40 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -15.4 | 2-Sided | 95 | -21.5 | -9.4 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 44 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 2.5 | 2-Sided | 95 | -3.2 | 8.4 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 48 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -15.9 | 2-Sided | 95 | -22.4 | -10.4 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 52 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -2.7 | 2-Sided | 95 | -8.5 | 3.1 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 56 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -9.0 | 2-Sided | 95 | -15.7 | -2.9 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 60 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -3.9 | 2-Sided | 95 | -9.8 | 2.2 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 64 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -15.1 | 2-Sided | 95 | -21.3 | -8.4 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 68 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.1 | 2-Sided | 95 | -6.1 | 6.2 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 72 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -16.6 | 2-Sided | 95 | -22.6 | -10.5 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 76 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.1 | 2-Sided | 95 | -7.0 | 5.1 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 80 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -11.0 | 2-Sided | 95 | -17.4 | -5.0 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 84 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -5.3 | 2-Sided | 95 | -11.3 | 0.7 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 88 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -12.0 | 2-Sided | 95 | -18.9 | -5.9 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 92 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -5.5 | 2-Sided | 95 | -11.4 | 0.0 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 96 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -14.5 | 2-Sided | 95 | -20.3 | -8.3 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 12 |
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| Week 16 |
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| Week 20 |
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| Week 24 |
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| Week 28 |
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| Week 32 |
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| Week 36 |
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| Week 40 |
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| Week 44 |
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| Week 48 |
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| Week 52 |
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| Week 56 |
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| Week 60 |
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| Week 64 |
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| Week 68 |
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| Week 72 |
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| Week 76 |
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| Week 80 |
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| Week 84 |
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| Week 88 |
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| Week 92 |
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| Week 96 |
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| Week 8 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -2.1 | 2-Sided | 95 | -6.1 | 1.7 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 12 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.4 | 2-Sided | 95 | -5.3 | 2.2 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 16 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.1 | 2-Sided | 95 | -4.5 | 4.4 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 20 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 8.2 | 2-Sided | 95 | 3.9 | 12.8 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 24 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -3.2 | 2-Sided | 95 | -7.9 | 1.2 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 28 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 2.8 | 2-Sided | 95 | -1.0 | 6.4 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 32 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.5 | 2-Sided | 95 | -5.5 | 4.0 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 36 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.8 | 2-Sided | 95 | -5.6 | 1.8 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 40 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.3 | 2-Sided | 95 | -6.0 | 3.1 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 44 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 3.8 | 2-Sided | 95 | -0.5 | 8.0 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 48 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -2.0 | 2-Sided | 95 | -6.2 | 2.2 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 52 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 1.2 | 2-Sided | 95 | -2.5 | 5.1 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 56 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.2 | 2-Sided | 95 | -5.9 | 3.1 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 60 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.6 | 2-Sided | 95 | -4.4 | 3.4 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 64 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.8 | 2-Sided | 95 | -6.2 | 2.1 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 68 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 2.6 | 2-Sided | 95 | -1.2 | 6.5 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 72 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.2 | 2-Sided | 95 | -4.2 | 4.3 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 76 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.4 | 2-Sided | 95 | -3.5 | 4.2 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 80 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.3 | 2-Sided | 95 | -4.8 | 4.3 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 84 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.9 | 2-Sided | 95 | -3.3 | 5.2 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 88 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.1 | 2-Sided | 95 | -4.5 | 3.9 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 92 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 3.8 | 2-Sided | 95 | -0.1 | 8.0 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 96 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.2 | 2-Sided | 95 | -4.3 | 4.6 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 12 |
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| Week 16 |
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| Week 20 |
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| Week 24 |
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| Week 28 |
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| Week 32 |
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| Week 36 |
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| Week 40 |
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| Week 44 |
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| Week 48 |
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| Week 52 |
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| Week 56 |
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| Week 60 |
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| Week 64 |
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| Week 68 |
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| Week 72 |
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| Week 76 |
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| Week 80 |
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| Week 84 |
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| Week 88 |
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| Week 92 |
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| Week 96 |
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| Week 8 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -2.6 | 2-Sided | 95 | -7.6 | 2.5 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 12 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.6 | 2-Sided | 95 | -6.9 | 3.7 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 16 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -7.8 | 2-Sided | 95 | -13.0 | -2.7 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 20 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 1.3 | 2-Sided | 95 | -3.6 | 6.2 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 24 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -7.9 | 2-Sided | 95 | -12.6 | -3.1 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 28 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -2.1 | 2-Sided | 95 | -6.8 | 2.7 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 32 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -5.3 | 2-Sided | 95 | -10.5 | -0.3 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 36 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -5.5 | 2-Sided | 95 | -10.3 | -0.4 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 40 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -6.0 | 2-Sided | 95 | -11.2 | -0.5 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 44 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.5 | 2-Sided | 95 | -4.8 | 5.6 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 48 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -9.1 | 2-Sided | 95 | -13.8 | -3.9 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 52 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.8 | 2-Sided | 95 | -7.1 | 3.5 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 56 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -5.2 | 2-Sided | 95 | -11.1 | 0.1 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 60 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -5.6 | 2-Sided | 95 | -10.9 | -0.5 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 64 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -5.1 | 2-Sided | 95 | -10.9 | 0.6 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 68 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -5.2 | 2-Sided | 95 | -11.0 | -0.1 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 72 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -6.9 | 2-Sided | 95 | -12.5 | -1.2 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 76 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -5.5 | 2-Sided | 95 | -10.7 | -0.3 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 80 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -6.5 | 2-Sided | 95 | -12.4 | -0.9 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 84 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -1.4 | 2-Sided | 95 | -7.0 | 4.4 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 88 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -4.8 | 2-Sided | 95 | -10.5 | 1.3 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 92 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -5.6 | 2-Sided | 95 | -11.4 | 0.5 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 96 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -5.9 | 2-Sided | 95 | -11.5 | -0.3 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 12 |
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| Week 16 |
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| Week 20 |
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| Week 24 |
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| Week 28 |
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| Week 32 |
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| Week 36 |
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| Week 40 |
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| Week 44 |
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| Week 48 |
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| Week 52 |
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| Week 56 |
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| Week 60 |
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| Week 64 |
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| Week 68 |
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| Week 72 |
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| Week 76 |
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| Week 80 |
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| Week 84 |
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| Week 88 |
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| Week 92 |
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| Week 96 |
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| Week 8 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -9.2 | 2-Sided | 95 | -15.5 | -2.5 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 12 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -8.7 | 2-Sided | 95 | -15.0 | -2.6 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 16 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -15.7 | 2-Sided | 95 | -22.9 | -9.0 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 20 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 7.7 | 2-Sided | 95 | 0.9 | 14.8 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 24 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -20.0 | 2-Sided | 95 | -27.3 | -13.1 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 28 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -3.9 | 2-Sided | 95 | -10.4 | 2.4 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 32 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -9.7 | 2-Sided | 95 | -16.7 | -2.5 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 36 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -9.4 | 2-Sided | 95 | -15.8 | -3.4 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 40 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -16.5 | 2-Sided | 95 | -23.4 | -9.6 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 44 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 3.4 | 2-Sided | 95 | -3.3 | 10.4 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 48 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -18.1 | 2-Sided | 95 | -24.9 | -11.8 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 52 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -3.0 | 2-Sided | 95 | -9.2 | 3.2 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 56 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -9.4 | 2-Sided | 95 | -16.3 | -2.8 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 60 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -5.7 | 2-Sided | 95 | -12.5 | 1.1 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 64 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -15.5 | 2-Sided | 95 | -21.9 | -8.5 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 68 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | 0.9 | 2-Sided | 95 | -5.9 | 7.5 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 72 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -14.9 | 2-Sided | 95 | -21.4 | -8.1 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 76 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -0.8 | 2-Sided | 95 | -7.5 | 5.4 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 80 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -10.4 | 2-Sided | 95 | -17.2 | -3.4 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 84 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -4.5 | 2-Sided | 95 | -11.4 | 2.3 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 88 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -11.0 | 2-Sided | 95 | -18.2 | -4.1 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 92 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -2.9 | 2-Sided | 95 | -9.4 | 3.5 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Week 96 | Regression, Logistic | Hypothesis testing not pre-specified. | Difference in proportions | -14.1 | 2-Sided | 95 | -21.3 | -7.2 | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. | Other |
| Change from baseline at Week 48 |
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| Change from baseline at Week 72 |
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| Change from baseline at Week 96 |
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| Week 48 |
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| Week 96 |
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| Week 48 |
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| Week 96 |
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