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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004742-23 | EudraCT Number |
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The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).
This was a Phase III, randomized, double-masked, multi-center, active-controlled, three-arm study designed to evaluate the efficacy and safety of brolucizumab 6 mg and 3 mg compared to the active control, aflibercept 2 mg used per authorized label, in subjects with diabetic macular edema (DME). The study included a screening period of up to 2 weeks to assess eligibility, followed by a doublemasked treatment period (Day 1 to Week 96). The baseline visit was defined as Day 1/Visit 1, and end of treatment visit as Visit 27 (Week 96). After the last treatment visit, a post-treatment follow-up period was planned from Week 96 to Week 100.
Subjects were assigned to one of three treatment arms in a 1:1:1 ratio: brolucizumab 6 mg/0.05 mL administered 5 x every 6 weeks (q6w) during loading phase then q12w/every 8 weeks (q8w) during maintenance phase, brolucizumab 3 mg/0.05 mL administered 5 x every 6 weeks (q6w) during loading phase then q12w/q8w during maintenance phase or aflibercept 2 mg/0.05 mL administered 5 x every 4 weeks (q4w) during loading phase then q8w during maintenance phase.
Disease Activity Assessments (DAAs) were conducted by the masked investigator for each treatment arm at Week 32 and Week 36, i.e. 8 and 12 weeks after the end of the loading phase for subjects receiving brolucizumab. Assessments were also performed at Week 48, and will then continue to be performed from Week 60 up to Week 96, every 12 weeks. Subjects in the brolucizumab arms who qualified for q12w during the initial q12w interval continued on a q12w treatment frequency unless disease activity was identified at any of the subsequent DAA visits, in which case subjects were switched to a q8w treatment interval until the end of the study.
To fulfil the double-masking requirement, each investigational site had masked and unmasked staff. The investigator who performed the injection was unmasked to the treatments as were any other site personnel who had been delegated responsibility for working with the Investigational Product (IP). The unmasked site personnel and unmasked injecting investigator did not perform Best-corrected visual acuity (BCVA), complete ophthalmic examination (with the exception of post-injection safety assessment), DAAs or administer the Visual Functioning Questionnaire-25 (VFQ-25). Also, the unmasked site personnel and unmasked injecting physician did not perform assessment of any ocular or non-ocular safety parameters, or assess causality of Adverse event (AEs) for subjects during the course of the study except an event reported immediately following Intravitreal treatment (IVT). Once the designated roles were determined, the unmasked investigator/site personnel roles were not switched at any time after randomization to masked role. Every effort was made to limit the number of unmasked study personnel to ensure the integrity of this masked study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brolucizumab 3 mg | Experimental | Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule. To fulfil the double-masking requirement, each investigational site had masked and unmasked staff. The investigator who performed the injection was unmasked to the treatments as were any other site personnel who had been delegated responsibility for working with the Investigational Product (IP). |
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| Brolucizumab 6 mg | Experimental | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule. To fulfil the double-masking requirement, each investigational site had masked and unmasked staff. The investigator who performed the injection was unmasked to the treatments as were any other site personnel who had been delegated responsibility for working with the Investigational Product (IP). |
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| Aflibercept 2 mg | Active Comparator | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks. To fulfil the double-masking requirement, each investigational site had masked and unmasked staff. The investigator who performed the injection was unmasked to the treatments as were any other site personnel who had been delegated responsibility for working with the Investigational Product (IP). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brolucizumab | Drug | Intravitreal injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. This endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept. | Baseline, Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Change From Baseline in BCVA Over the Period Week 40 Through Week 52 | BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (per the inclusion criteria) (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. This endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-specified inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Phoenix | Arizona | 85053 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novctrd.com | View source |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Brolucizumab 3 mg | Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule |
| FG001 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Sep 28, 2021 | May 27, 2022 |
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| Aflibercept | Drug | Intravitreal injection |
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| Baseline and Week 40 through Week 52 (average) |
| Patients Maintained at q12w - Probability of Maintaining on q12w | Positive treatment status is defined as intravitreal (IVT) injections per planned dosing regimen [every 12 weeks (q12w)]. This outcome measure is pre-specified for brolucizumab treatment arms only. | Baseline (Week 0), Weeks 32, 36 and 48 |
| Patients Maintained at q12w (for Those Patients Who Qualified for q12w at Week 36) - Probability of Maintaining on q12w | Positive treatment status is defined as intravitreal (IVT) injections per planned dosing regimen [every 8 weeks (q8w)]. This outcome measure is pre-specified for brolucizumab treatment arms only. | Weeks 36 and 48 |
| Change From Baseline in BCVA at Each Visit up to Week 52 | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. | Baseline (Week 0), Weeks 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
| BCVA (Letters Read): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (FAS - LOCF) | Visual acuity was assessed at every study visit using best correction determined from protocol refraction (BCVA). BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. LS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept. | Baseline, and Week 88 through Week 100 (average) |
| Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w | This outcome measure is pre-specified for brolucizumab treatment arms only | Baseline (Week 0), Weeks 32, 36, 48, 60, 72, 84, and 96 |
| Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w | This outcome measure is pre-specified for brolucizumab treatment arms only | Baseline (Week 0), Weeks 32, 36, 48, 60, 72, 84, and 96 |
| Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. LS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept. | Baseline up to week 52 |
| Central Subfield Thickness (CSFT) (Micrometers): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (Full Analysis Set - LOCF) | Central subfield thickness (average thickness of circular 1mm area centered around fovea measured from RPE to ILM, inclusively). Assessed with Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. LS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept. | Baseline, and Week 88 through Week 100 (average) |
| Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Subretinal Fluid (SRF) status in the central subfield: proportion of subjects with presence of SRF in the study eye by visit | Baseline up to Week 52 and Week 100 |
| Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with presence of IRF in the study eye by visit | Baseline, up to Week 52 and Week 100 |
| Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with presence of SRF and/or IRF in the study eye by visit | Baseline, up to Week 52 and Week 100 |
| Number of Patients With Presence of Leakage on Fluorescein Angiography (FA) at Week 52 | Assessed by angiography. | Week 52 |
| Number of Patients With Presence of Leakage on Fluorescein Angiography (FA) at Week 100 | Assessed by angiography. | Week 100 |
| Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning. | Baseline, Weeks 28, 52, 76, 100 |
| Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.
Abbreviation: Proportion Estimates = P.E. | Baseline, Weeks 28, 52, 76, 100 |
| Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning. | Baseline, Weeks 28, 52, 76, 100 |
| Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.
Abbreviation: Proportion Estimates = P.E. | Baseline, Weeks 28, 52, 76, 100 |
| Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Composite Score | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | Baseline, Weeks 28, 52, 76, 100 |
| Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Vision | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | Baseline, Weeks 28, 52, 76, 100 |
| Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Ocular Pain | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | Baseline, Weeks 28, 52, 76, 100 |
| Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Near Activities | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | Baseline, Weeks 28, 52, 76, 100 |
| Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Distance Activities | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | Baseline, Weeks 28, 52, 76, 100 |
| Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Social Functioning | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | Baseline, Weeks 28, 52, 76, 100 |
| Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Mental Health | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | Baseline, Weeks 28, 52, 76, 100 |
| Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Role Difficulties | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | Baseline, Weeks 28, 52, 76, 100 |
| Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Dependency | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | Baseline, Weeks 28, 52, 76, 100 |
| Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Driving | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | Baseline, Weeks 28, 52, 76, 100 |
| Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Color Vision | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | Baseline, Weeks 28, 52, 76, 100 |
| Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Peripheral Vision | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | Baseline, Weeks 28, 52, 76, 100 |
| Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Health Rating | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | Baseline, Weeks 28, 52, 76, 100 |
| Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks. |
| Number of Subjects With Non-ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) | Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks. |
| Beverly Hills |
| California |
| 90211 |
| United States |
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| Novartis Investigative Site | Tsuchiura | Ibaragi | 300-0817 | Japan |
| Novartis Investigative Site | Ishioka | Ibaraki | 315-0037 | Japan |
| Novartis Investigative Site | Kagoshima | Kagoshima-ken | 890 8520 | Japan |
| Novartis Investigative Site | Matsumoto | Nagano | 390-8621 | Japan |
| Novartis Investigative Site | Saitama-shi | Saitama | 336-0963 | Japan |
| Novartis Investigative Site | Shimotsuke | Tochigi | 329-0498 | Japan |
| Novartis Investigative Site | Chiyoda-ku | Tokyo | 101-8309 | Japan |
| Novartis Investigative Site | Hachiōji | Tokyo | 193-0944 | Japan |
| Novartis Investigative Site | Shinjuku Ku | Tokyo | 162 8666 | Japan |
| Novartis Investigative Site | Taito-ku | Tokyo | 111-0051 | Japan |
| Novartis Investigative Site | Kumamoto | Japan |
| Novartis Investigative Site | Osaka | 543-0027 | Japan |
| Novartis Investigative Site | Amsterdam | 1105 AZ | Netherlands |
| Novartis Investigative Site | Rotterdam | 3011 BH | Netherlands |
| Novartis Investigative Site | Tilburg | 5022 GC | Netherlands |
| Novartis Investigative Site | Coimbra | 3000-548 | Portugal |
| Novartis Investigative Site | Coimbra | 3030-363 | Portugal |
| Novartis Investigative Site | Leiria | 2410-187 | Portugal |
| Novartis Investigative Site | Porto | 4099-001 | Portugal |
| Novartis Investigative Site | Porto | 4200 319 | Portugal |
| Novartis Investigative Site | Santa Maria da Feira | 4520 211 | Portugal |
| Novartis Investigative Site | Vila Franca de Xira | 2600-009 | Portugal |
| Novartis Investigative Site | Arecibo | 00612 | Puerto Rico |
| Novartis Investigative Site | Valladolid | Castille and León | 47011 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08036 | Spain |
| Novartis Investigative Site | Sant Cugat del Vallès | Catalonia | 08190 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46014 | Spain |
| Novartis Investigative Site | Barcelona | 08025 | Spain |
| Novartis Investigative Site | Zaragoza | 50009 | Spain |
| Novartis Investigative Site | Frimley | Surrey | GU16 7UJ | United Kingdom |
| Novartis Investigative Site | Birmingham | B18 7QH | United Kingdom |
| Novartis Investigative Site | Hull | HU3 2JZ | United Kingdom |
| Novartis Investigative Site | London | NW10 7NS | United Kingdom |
| Novartis Investigative Site | Nottingham | NG7 2UH | United Kingdom |
| FG002 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Brolucizumab 3 mg | Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule |
| BG001 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule |
| BG002 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. This endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept. | Full analysis set (FAS) - Last observation carried forward (LOCF). This endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline, Week 52 |
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| Secondary | Average Change From Baseline in BCVA Over the Period Week 40 Through Week 52 | BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (per the inclusion criteria) (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. This endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept. | Full analysis set (FAS) - Observed. This endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline and Week 40 through Week 52 (average) |
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| Secondary | Patients Maintained at q12w - Probability of Maintaining on q12w | Positive treatment status is defined as intravitreal (IVT) injections per planned dosing regimen [every 12 weeks (q12w)]. This outcome measure is pre-specified for brolucizumab treatment arms only. | FAS - Efficacy/Safety approach | Posted | Number | 95% Confidence Interval | Probability | Baseline (Week 0), Weeks 32, 36 and 48 |
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| Secondary | Patients Maintained at q12w (for Those Patients Who Qualified for q12w at Week 36) - Probability of Maintaining on q12w | Positive treatment status is defined as intravitreal (IVT) injections per planned dosing regimen [every 8 weeks (q8w)]. This outcome measure is pre-specified for brolucizumab treatment arms only. | FAS - Efficacy/Safety approach | Posted | Number | 95% Confidence Interval | Probability | Weeks 36 and 48 |
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| Secondary | Change From Baseline in BCVA at Each Visit up to Week 52 | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. | Full analysis set (FAS) | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Week 0), Weeks 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
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| Secondary | BCVA (Letters Read): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (FAS - LOCF) | Visual acuity was assessed at every study visit using best correction determined from protocol refraction (BCVA). BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. LS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept. | Full Analysis Set - LOCF | Posted | Least Squares Mean | Standard Error | BCVA letters read | Baseline, and Week 88 through Week 100 (average) |
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| Secondary | Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w | This outcome measure is pre-specified for brolucizumab treatment arms only | FAS - Efficacy/Safety approach | Posted | Number | 95% Confidence Interval | Probability | Baseline (Week 0), Weeks 32, 36, 48, 60, 72, 84, and 96 |
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| Secondary | Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w | This outcome measure is pre-specified for brolucizumab treatment arms only | FAS - Efficacy/Safety approach | Posted | Number | 95% Confidence Interval | Probability | Baseline (Week 0), Weeks 32, 36, 48, 60, 72, 84, and 96 |
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| Secondary | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. LS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept. | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | Least Squares Mean | Standard Error | μm | Baseline up to week 52 |
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| Secondary | Central Subfield Thickness (CSFT) (Micrometers): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (Full Analysis Set - LOCF) | Central subfield thickness (average thickness of circular 1mm area centered around fovea measured from RPE to ILM, inclusively). Assessed with Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. LS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept. | Full Analysis Set - LOCF | Posted | Least Squares Mean | Standard Error | micrometers | Baseline, and Week 88 through Week 100 (average) |
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| Secondary | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Subretinal Fluid (SRF) status in the central subfield: proportion of subjects with presence of SRF in the study eye by visit | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | Count of Participants | Participants | Baseline up to Week 52 and Week 100 |
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| Secondary | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with presence of IRF in the study eye by visit | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | Count of Participants | Participants | Baseline, up to Week 52 and Week 100 |
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| Secondary | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with presence of SRF and/or IRF in the study eye by visit | Full analysis set (FAS) - Last observation carried forward (LOCF) | Posted | Count of Participants | Participants | Baseline, up to Week 52 and Week 100 |
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| Secondary | Number of Patients With Presence of Leakage on Fluorescein Angiography (FA) at Week 52 | Assessed by angiography. | Full analysis set (FAS) - Last observation carried forward (LOCF). The angiogram results are not available at baseline on all participants because in rare cases, the images could not be read e.g., because of poor quality. | Posted | Count of Participants | Participants | Week 52 |
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| Secondary | Number of Patients With Presence of Leakage on Fluorescein Angiography (FA) at Week 100 | Assessed by angiography. | Full analysis set (FAS) - Last observation carried forward (LOCF). The angiogram results are not available at baseline on all participants because in rare cases, the images could not be read e.g., because of poor quality. | Posted | Count of Participants | Participants | Week 100 |
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| Secondary | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning. | Full analysis set (FAS) - Last observation carried forward (LOCF). The results are not available at baseline on all participants because in rare cases, the images could not be read e.g., because of poor quality. | Posted | Count of Participants | Participants | Baseline, Weeks 28, 52, 76, 100 |
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| Secondary | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.
Abbreviation: Proportion Estimates = P.E. | Full analysis set (FAS) - Last observation carried forward (LOCF). The results are not available at baseline on all participants because in rare cases, the images could not be read e.g., because of poor quality. | Posted | Number | Percentage estimates | Baseline, Weeks 28, 52, 76, 100 |
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| Secondary | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning. | Full analysis set (FAS) - Last observation carried forward (LOCF). The results are not available at baseline on all participants because in rare cases, the images could not be read e.g., because of poor quality. | Posted | Count of Participants | Participants | Baseline, Weeks 28, 52, 76, 100 |
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| Secondary | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.
Abbreviation: Proportion Estimates = P.E. | Full analysis set (FAS) - Last observation carried forward (LOCF). The results are not available at baseline on all participants because in rare cases, the images could not be read e.g., because of poor quality. | Posted | Number | Percentage estimates | Baseline, Weeks 28, 52, 76, 100 |
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| Secondary | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Composite Score | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | FAS - Observed | Posted | Mean | Standard Deviation | overall scores | Baseline, Weeks 28, 52, 76, 100 |
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| Secondary | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Vision | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | FAS - Observed | Posted | Mean | Standard Deviation | overall scores | Baseline, Weeks 28, 52, 76, 100 |
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| Secondary | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Ocular Pain | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | FAS - Observed | Posted | Mean | Standard Deviation | overall scores | Baseline, Weeks 28, 52, 76, 100 |
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| Secondary | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Near Activities | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | FAS - Observed | Posted | Mean | Standard Deviation | overall scores | Baseline, Weeks 28, 52, 76, 100 |
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| Secondary | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Distance Activities | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | FAS - Observed | Posted | Mean | Standard Deviation | overall scores | Baseline, Weeks 28, 52, 76, 100 |
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| Secondary | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Social Functioning | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | FAS - Observed | Posted | Mean | Standard Deviation | overall scores | Baseline, Weeks 28, 52, 76, 100 |
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| Secondary | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Mental Health | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | FAS - Observed | Posted | Mean | Standard Deviation | overall scores | Baseline, Weeks 28, 52, 76, 100 |
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| Secondary | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Role Difficulties | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | FAS - Observed | Posted | Mean | Standard Deviation | overall scores | Baseline, Weeks 28, 52, 76, 100 |
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| Secondary | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Dependency | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | FAS - Observed | Posted | Mean | Standard Deviation | overall scores | Baseline, Weeks 28, 52, 76, 100 |
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| Secondary | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Driving | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | FAS - Observed | Posted | Mean | Standard Deviation | overall scores | Baseline, Weeks 28, 52, 76, 100 |
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| Secondary | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Color Vision | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | FAS - Observed | Posted | Mean | Standard Deviation | overall scores | Baseline, Weeks 28, 52, 76, 100 |
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| Secondary | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Peripheral Vision | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | FAS - Observed | Posted | Mean | Standard Deviation | overall scores | Baseline, Weeks 28, 52, 76, 100 |
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| Secondary | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Health Rating | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. | FAS - Observed | Posted | Mean | Standard Deviation | overall scores | Baseline, Weeks 28, 52, 76, 100 |
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| Secondary | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Safety Set | Posted | Count of Participants | Participants | Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks. |
|
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| Secondary | Number of Subjects With Non-ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) | Safety Set | Posted | Count of Participants | Participants | Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks. |
|
|
Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brolucizumab 3mg | Brolucizumab 3mg | 4 | 190 | 58 | 190 | 146 | 190 |
| EG001 | Brolucizumab 6mg | Brolucizumab 6mg | 8 | 189 | 59 | 189 | 148 | 189 |
| EG002 | Aflibercept 2mg | Aflibercept 2mg | 7 | 187 | 63 | 187 | 137 | 187 |
| EG003 | Overall | Overall | 19 | 566 | 180 | 566 | 431 | 566 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Acute left ventricular failure | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Cardiorenal syndrome | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Cardiovascular disorder | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Mitral valve disease mixed | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Amaurosis fugax - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Cataract - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Cataract - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Conjunctival cyst - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Diabetic retinal oedema - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Diabetic retinopathy - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Epiretinal membrane - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Glaucoma - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Glaucoma - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Macular oedema - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Posterior capsule opacification - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Pterygium - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Retinal artery occlusion - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Retinal artery occlusion - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Retinal detachment - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Retinal occlusive vasculitis - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Retinal vasculitis - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Retinal vein thrombosis - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Uveitis - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Visual acuity reduced - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Vitreous floaters - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Vitreous haemorrhage - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Vitritis - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Gastric polyps | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Mechanical ileus | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Mesenteric vein thrombosis | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Proctitis ulcerative | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Rectal polyp | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Ulcerative gastritis | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Gallbladder disorder | Hepatobiliary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Diabetic foot infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Endophthalmitis - Study eye | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Fungal sepsis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Gas gangrene | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Osteomyelitis acute | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Postoperative abscess | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Cataract operation complication - Fellow eye | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Laryngeal injury | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Peripheral artery restenosis | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Skin flap necrosis | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Hepatitis C antibody positive | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Intraocular pressure increased - Study eye | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Diabetic metabolic decompensation | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
| |
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
| |
| Ovarian cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
| |
| Carotid artery occlusion | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Cerebral atrophy | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Lacunar stroke | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Optic neuritis - Study eye | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA (24.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Diabetic nephropathy | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| End stage renal disease | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Nephropathy | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Urinary bladder rupture | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Prostatic disorder | Reproductive system and breast disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Accelerated hypertension | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Dry gangrene | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Embolism venous | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hypertensive urgency | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Blepharitis - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Blepharitis - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Cataract - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Cataract - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Cataract subcapsular - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Conjunctival haemorrhage - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Conjunctival haemorrhage - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Conjunctival hyperaemia - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Conjunctivitis allergic - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Diabetic retinal oedema - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Diabetic retinal oedema - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Diabetic retinopathy - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Dry eye - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Dry eye - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Eye irritation - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Eye irritation - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Eye pain - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Eye pain - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Iridocyclitis - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Keratitis - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Macular oedema - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Ocular hypertension - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Ocular hypertension - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Posterior capsule opacification - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Punctate keratitis - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Retinal exudates - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Retinal exudates - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Retinal haemorrhage - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Retinal haemorrhage - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Vision blurred - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Visual acuity reduced - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Visual acuity reduced - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Vitreoretinal traction syndrome - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Vitreous detachment - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Vitreous detachment - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Vitreous floaters - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Vitreous floaters - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Vitreous haemorrhage - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Vitreous haemorrhage - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Conjunctivitis - Fellow eye | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Conjunctivitis - Study eye | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Corneal abrasion - Study eye | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Glucose urine present | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Glycosylated haemoglobin increased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Intraocular pressure increased - Fellow eye | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Intraocular pressure increased - Study eye | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (24.1) | 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 (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | Novartis.email@Novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 26, 2020 | Jul 7, 2022 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000622091 | brolucizumab |
| C533178 | aflibercept |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| LS mean estimate (Brolucizumab 6 mg vs. Aflibercept 2 mg) |
|
|
| 0.227 |
1-sided p-value |
| LS mean difference |
| -3.3 |
| Standard Error of the Mean |
| 0.94 |
| 2-Sided |
| 95 |
| -5.1 |
| -1.4 |
| Non-Inferiority |
Non-inferiority (4-letter margin) |
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|
| OG001 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule |
| OG002 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
|
|
|
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|
| OG001 | Brolucizumab 6 mg | Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule |
| OG002 | Aflibercept 2 mg | Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks |
|
|
|
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|
|
|
|
|
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|
|
|