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Sponsor Decision
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This clinical study was designed to compare the safety and efficacy of brolucizumab 6 mg dosed every 4 weeks to aflibercept 2 mg dosed every 4 weeks in those neovascular age-related macular degeneration (nAMD) patients with retinal fluid despite frequent anti-Vascular Endothelial Growth Factor (VEGF) injections.
This was a Phase III, multi-center, randomized, double-masked, parallel group study with 2 masked arms in which participants were randomized 2:1 to receive brolucizumab or aflibercept. All participants had study visits every 4 weeks through week 104.
The study consisted of three study periods:
Screening Period: The screening period lasted up to 2 weeks prior to administration of the first dose of study treatment, dependent upon confirmation of the patient meeting eligibility criteria.
Double-Masked Treatment Period: Participants meeting eligibility criteria entered the treatment period and were randomized in a 2:1 ratio into one of the following 2 masked treatment arms at the Baseline visit: Brolucizumab 6 mg injected every 4 weeks or Aflibercept 2 mg injected every 4 weeks. Treatment period lasted up to week 100.
Safety Follow up Period: Participants were followed up for safety during 4 weeks after the last dose of study treatment. Including the Screening Period, the total study duration for a participant was up to 106 weeks.
Some participants were eligible to continue into an extension study in order to receive treatment with brolucizumab (a) after completing the 104 -week double-masked treatment period, (b) upon meeting all inclusion/exclusion criteria for the extension study, and (c) based on Investigator's judgment that the participant was expected to benefit from treatment with brolucizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brolucizumab | Experimental | Brolucizumab 6 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks. |
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| Aflibercept | Active Comparator | Aflibercept 2 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brolucizumab | Biological | 6 mg/0.05mL solution for 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 the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. A positive change from baseline represents better functioning. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. Last observation carried forward (LOCF) was used for the imputation of missing values. | Baseline, week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Stable Visual Acuity (VA) or Improvement in VA at Week 52 and Week 104 | Visual Acuity (VA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. VA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of participants with no change or gain in VA compared to baseline was reported. VA stabilization or improvement is defined as a change from baseline no worse than 5 letters loss in VA compared to Baseline. Baseline VA was defined as the last measurement on or prior to the baseline visit. VA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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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 | 85016 | 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 | Brolucizumab 6 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks. |
| FG001 | Aflibercept | Aflibercept 2 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks. |
| 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 | Jun 11, 2020 | Jun 28, 2022 |
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multicenter, randomized, double-masked
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| Aflibercept | Biological | 2 mg/0.05mL solution for intravitreal injection |
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| Baseline, weeks 52 and 104 |
| Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with loss in BCVA of 5 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. | 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, 100 and 104 |
| Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with loss in BCVA of 10 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. | 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, 100 and 104 |
| Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with loss in BCVA of 15 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. | 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, 100 and 104 |
| Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with gain in BCVA of 5 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. | 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, 100 and 104 |
| Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with gain in BCVA of 10 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. | 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, 100 and 104 |
| Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with gain in BCVA of 15 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. | 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, 100 and 104 |
| Change in Central Subfield Thickness (CST) From Baseline | CST was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. A negative change from baseline is a favorable outcome. CST assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. These results were based on analysis using the Last observation carried forward (LOCF) approach for replacement/imputation of censored/missing values and observed data. | 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, 100 and 104 |
| Number of Participants With Intraretinal Fluid (IRF) | IRF was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. The number of participants with presence of IRF was reported for each post-baseline visit. These results were based on analysis using the Last observation carried forward (LOCF) approach for replacement/imputation of censored/missing values and observed data. | 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, 100 and 104 |
| Number of Participants With Subretinal Fluid (SRF) | SRF was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. The number of participants with presence of SRF was reported for each post-baseline visit. These results were based on analysis using the Last observation carried forward (LOCF) approach for replacement/imputation of censored/missing values and observed data. | 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, 100 and 104 |
| Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Sub-RPE fluid was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. The number of participants with presence of sub-RPE fluid in participants with sub-RPE fluid at baseline was reported for each post-baseline visit. These results were based on analysis using the Last observation carried forward (LOCF) approach for replacement/imputation of censored/missing values and observed data. | 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, 100 and 104 |
| Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Intraretinal fluid (IRF), Subretinal fluid (SRF) and Sub-Retinal Pigment Epithelium fluid (sub-RPE) were assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. The number of participants with fluid-free status (simultaneous absence of IRF, SRF, and sub-RPE) was reported for each post-baseline visit. These results were based on analysis using the Last observation carried forward (LOCF) approach for replacement/imputation of censored/missing values and observed data. | 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, 100 and 104 |
| Time to First Dry Retina (no IRF or SRF) | Intraretinal fluid (IRF) and Subretinal fluid (SRF) were assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. A dry retina is defined as no IRF or SRF at the respective visit. Kaplan-Meier method was used for estimate of percentiles with 95% CI based on methodology of Brookmeyer and Crowley. Data was censored at the last time when IRF/SRF assessments for fluid-free retina were available for participants who discontinued on/or prior to the time of the start of alternative anti-VEGF treatment. IRF and SRF assessments on unscheduled visits were considered. | Baseline, Up to Week 104 (assessments every 4 weeks) |
| Time to Sustained Dry Retina (no IRF or SRF at ≥ 2 Consecutive Visits) | Intraretinal fluid (IRF) and Subretinal fluid (SRF) were assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. A sustained dry retina is defined as no IRF or SRF at 2 or more consecutive visits. Kaplan-Meier method was used for estimate of percentiles with 95% CI based on methodology of Brookmeyer and Crowley. Data was censored at the last time when IRF/SRF assessments for fluid-free retina were available for participants who discontinued on/or prior to the time of the start of alternative anti-VEGF treatment. IRF and SRF assessments on unscheduled visits were considered. | Baseline, Up to Week 104 (assessments every 4 weeks) |
| Number of Participants With Anti-drug Antibody (ADA) Negative Status | A blood sample was collected for anti-drug antibody assessment. ADA negative status = ADA negative result at the corresponding study visit. The baseline sample was collected prior to first dose of study treatment and the post-baseline assessments were taken at the scheduled timepoints. A negative Titer was used to assess the ADA status for the brolucizumab arm. | Baseline, weeks 4, 12, 24, 36, 52, 76 and 104 |
| Free Brolucizumab Serum Concentration | A blood sample was collected for Free Brolucizumab serum concentration assessment. This outcome measure was pre-specified for the brolucizumab arm only. The baseline sample was collected prior to first dose of study treatment and the post-baseline assessments. Values below the limit of quantification (BLQ) (<0.5 ng/mL) were replaced by one half of the LLOQ (0.25 ng/mL) in the calculation of the summary statistics. For the Mean score at each visit, if the calculated value was less than 0.5, then "NA" was displayed instead; meaning that the score is below the limit of quantitation (<0.5 ng/mL). | pre-dose a baseline, weeks 4, 12, 24, 36, 52, 76 and 104 |
| Phoenix |
| Arizona |
| 85020 |
| United States |
| Novartis Investigative Site | Phoenix | Arizona | 85053 | United States |
| Novartis Investigative Site | Beverly Hills | California | 90211 | United States |
| Novartis Investigative Site | Huntington Beach | California | 92647 | United States |
| Novartis Investigative Site | Mountain View | California | 94040 | United States |
| Novartis Investigative Site | Oakland | California | 94609 | United States |
| Novartis Investigative Site | Oxnard | California | 93036 | United States |
| Novartis Investigative Site | Palo Alto | California | 94303 | United States |
| Novartis Investigative Site | Redlands | California | 92374 | United States |
| Novartis Investigative Site | Sacramento | California | 95841 | United States |
| Novartis Investigative Site | San Francisco | California | 94107 | United States |
| Novartis Investigative Site | Santa Barbara | California | 93103 | United States |
| Novartis Investigative Site | Colorado Springs | Colorado | 80909 | United States |
| Novartis Investigative Site | Golden | Colorado | 80401 | United States |
| Novartis Investigative Site | Deerfield Beach | Florida | 33064 | United States |
| Novartis Investigative Site | Fort Lauderdale | Florida | 33308 | United States |
| Novartis Investigative Site | Fort Myers | Florida | 33912-7125 | United States |
| Novartis Investigative Site | Miami | Florida | 33136 | United States |
| Novartis Investigative Site | Mt. Dora | Florida | 32757 | United States |
| Novartis Investigative Site | Pensacola | Florida | 32503 | United States |
| Novartis Investigative Site | St. Petersburg | Florida | 33711 | United States |
| Novartis Investigative Site | Stuart | Florida | 34994 | United States |
| Novartis Investigative Site | Marietta | Georgia | 30060 | United States |
| Novartis Investigative Site | ‘Aiea | Hawaii | 96701 | United States |
| Novartis Investigative Site | Wheaton | Illinois | 60187 | United States |
| Novartis Investigative Site | West Des Moines | Iowa | 50266 | United States |
| Novartis Investigative Site | Lenexa | Kansas | 66215 | United States |
| Novartis Investigative Site | New Orleans | Louisiana | 70115-8139 | United States |
| Novartis Investigative Site | West Monroe | Louisiana | 71291 | United States |
| Novartis Investigative Site | Waldorf | Maryland | 20602 | United States |
| Novartis Investigative Site | Boston | Massachusetts | 02111 | United States |
| Novartis Investigative Site | Boston | Massachusetts | 02114 | United States |
| Novartis Investigative Site | Springfield | Massachusetts | 01107 | United States |
| Novartis Investigative Site | Royal Oak | Michigan | 48073 | United States |
| Novartis Investigative Site | St Louis | Missouri | 63110 | United States |
| Novartis Investigative Site | Las Vegas | Nevada | 89144 | United States |
| Novartis Investigative Site | Reno | Nevada | 89502 | United States |
| Novartis Investigative Site | Bloomfield | New Jersey | 07003 | United States |
| Novartis Investigative Site | Toms River | New Jersey | 08755 | United States |
| Novartis Investigative Site | Syracuse | New York | 13224 | United States |
| Novartis Investigative Site | Charlotte | North Carolina | 28210 | United States |
| Novartis Investigative Site | Cleveland | Ohio | 44122 | United States |
| Novartis Investigative Site | Fairfield | Ohio | 45014 | United States |
| Novartis Investigative Site | Eugene | Oregon | 97401 | United States |
| Novartis Investigative Site | Kingston | Pennsylvania | 95403 | United States |
| Novartis Investigative Site | Philadelphia | Pennsylvania | 19107 | United States |
| Novartis Investigative Site | Germantown | Tennessee | 38138 | United States |
| Novartis Investigative Site | Abilene | Texas | 79606 | United States |
| Novartis Investigative Site | Austin | Texas | 78705 | United States |
| Novartis Investigative Site | Austin | Texas | 78731 | United States |
| Novartis Investigative Site | Austin | Texas | 78793 | United States |
| Novartis Investigative Site | Fort Worth | Texas | 76102 | United States |
| Novartis Investigative Site | Fort Worth | Texas | 76104 | United States |
| Novartis Investigative Site | Harlingen | Texas | 78550 | United States |
| Novartis Investigative Site | Houston | Texas | 77030 | United States |
| Novartis Investigative Site | San Antonio | Texas | 78240 | United States |
| Novartis Investigative Site | Tyler | Texas | 75701 | United States |
| Novartis Investigative Site | Fairfax | Virginia | 22031 | United States |
| Novartis Investigative Site | Spokane | Washington | 99204 | United States |
| Novartis Investigative Site | Arecibo | 00612 | Puerto Rico |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Brolucizumab | Brolucizumab 6 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks. |
| BG001 | Aflibercept | Aflibercept 2 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks. |
| BG002 | 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, 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 the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. A positive change from baseline represents better functioning. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. Last observation carried forward (LOCF) was used for the imputation of missing values. | All randomized participants | Posted | Mean | Standard Deviation | Score on a scale | Baseline, week 52 |
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| Secondary | Stable Visual Acuity (VA) or Improvement in VA at Week 52 and Week 104 | Visual Acuity (VA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. VA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of participants with no change or gain in VA compared to baseline was reported. VA stabilization or improvement is defined as a change from baseline no worse than 5 letters loss in VA compared to Baseline. Baseline VA was defined as the last measurement on or prior to the baseline visit. VA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. | The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point. | Posted | Count of Participants | Participants | Baseline, weeks 52 and 104 |
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| Secondary | Loss in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with loss in BCVA of 5 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. | The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point. | Posted | Count of Participants | Participants | 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, 100 and 104 |
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| Secondary | Loss in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with loss in BCVA of 10 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. | The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point. | Posted | Count of Participants | Participants | 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, 100 and 104 |
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| Secondary | Loss in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with loss in BCVA of 15 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. | The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point. | Posted | Count of Participants | Participants | 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, 100 and 104 |
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| Secondary | Gain in Best-Corrected Visual Acuity (BCVA) of 5 Letters or More | BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with gain in BCVA of 5 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. | The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point. | Posted | Count of Participants | Participants | 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, 100 and 104 |
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| Secondary | Gain in Best-Corrected Visual Acuity (BCVA) of 10 Letters or More | BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with gain in BCVA of 10 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. | The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point. | Posted | Count of Participants | Participants | 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, 100 and 104 |
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| Secondary | Gain in Best-Corrected Visual Acuity (BCVA) of 15 Letters or More | BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. BCVA min and max possible scores are 0-100 respectively and a higher score represents better functioning. The number of subjects with gain in BCVA of 15 letters or more from baseline was reported for each post-baseline visit. Baseline BCVA was defined as the last measurement on or prior to the baseline visit. BCVA assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. | The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point. | Posted | Count of Participants | Participants | 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, 100 and 104 |
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| Secondary | Change in Central Subfield Thickness (CST) From Baseline | CST was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. A negative change from baseline is a favorable outcome. CST assessments after start of alternative anti-VEGF treatment in the study eye were censored and imputed by the last value prior to start of alternative treatment. These results were based on analysis using the Last observation carried forward (LOCF) approach for replacement/imputation of censored/missing values and observed data. | All randomized participants | Posted | Least Squares Mean | Standard Error | µm | 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, 100 and 104 |
|
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| Secondary | Number of Participants With Intraretinal Fluid (IRF) | IRF was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. The number of participants with presence of IRF was reported for each post-baseline visit. These results were based on analysis using the Last observation carried forward (LOCF) approach for replacement/imputation of censored/missing values and observed data. | The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with evaluable data at each time point. | Posted | Count of Participants | Participants | 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, 100 and 104 |
|
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| Secondary | Number of Participants With Subretinal Fluid (SRF) | SRF was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. The number of participants with presence of SRF was reported for each post-baseline visit. These results were based on analysis using the Last observation carried forward (LOCF) approach for replacement/imputation of censored/missing values and observed data. | The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with evaluable data at each time point. | Posted | Count of Participants | Participants | 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, 100 and 104 |
|
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| Secondary | Number of Participants With Sub-Retinal Pigment Epithelium (Sub-RPE) Fluid | Sub-RPE fluid was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. The number of participants with presence of sub-RPE fluid in participants with sub-RPE fluid at baseline was reported for each post-baseline visit. These results were based on analysis using the Last observation carried forward (LOCF) approach for replacement/imputation of censored/missing values and observed data. | The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with evaluable data at each time point. | Posted | Count of Participants | Participants | 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, 100 and 104 |
|
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| Secondary | Number of Participants With Fluid-free Status (no IRF, SRF or Sub-RPE Fluid) | Intraretinal fluid (IRF), Subretinal fluid (SRF) and Sub-Retinal Pigment Epithelium fluid (sub-RPE) were assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. The number of participants with fluid-free status (simultaneous absence of IRF, SRF, and sub-RPE) was reported for each post-baseline visit. These results were based on analysis using the Last observation carried forward (LOCF) approach for replacement/imputation of censored/missing values and observed data. | The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with evaluable data at each time point. | Posted | Count of Participants | Participants | 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, 100 and 104 |
|
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| Secondary | Time to First Dry Retina (no IRF or SRF) | Intraretinal fluid (IRF) and Subretinal fluid (SRF) were assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. A dry retina is defined as no IRF or SRF at the respective visit. Kaplan-Meier method was used for estimate of percentiles with 95% CI based on methodology of Brookmeyer and Crowley. Data was censored at the last time when IRF/SRF assessments for fluid-free retina were available for participants who discontinued on/or prior to the time of the start of alternative anti-VEGF treatment. IRF and SRF assessments on unscheduled visits were considered. | All randomized participants | Posted | Median | 95% Confidence Interval | Days | Baseline, Up to Week 104 (assessments every 4 weeks) |
|
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| Secondary | Time to Sustained Dry Retina (no IRF or SRF at ≥ 2 Consecutive Visits) | Intraretinal fluid (IRF) and Subretinal fluid (SRF) were assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images. A sustained dry retina is defined as no IRF or SRF at 2 or more consecutive visits. Kaplan-Meier method was used for estimate of percentiles with 95% CI based on methodology of Brookmeyer and Crowley. Data was censored at the last time when IRF/SRF assessments for fluid-free retina were available for participants who discontinued on/or prior to the time of the start of alternative anti-VEGF treatment. IRF and SRF assessments on unscheduled visits were considered. | All randomized participants | Posted | Median | 95% Confidence Interval | Days | Baseline, Up to Week 104 (assessments every 4 weeks) |
|
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| Secondary | Number of Participants With Anti-drug Antibody (ADA) Negative Status | A blood sample was collected for anti-drug antibody assessment. ADA negative status = ADA negative result at the corresponding study visit. The baseline sample was collected prior to first dose of study treatment and the post-baseline assessments were taken at the scheduled timepoints. A negative Titer was used to assess the ADA status for the brolucizumab arm. | The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point. This outcome measure was pre-specified for the brolucizumab arm only. | Posted | Count of Participants | Participants | Baseline, weeks 4, 12, 24, 36, 52, 76 and 104 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Free Brolucizumab Serum Concentration | A blood sample was collected for Free Brolucizumab serum concentration assessment. This outcome measure was pre-specified for the brolucizumab arm only. The baseline sample was collected prior to first dose of study treatment and the post-baseline assessments. Values below the limit of quantification (BLQ) (<0.5 ng/mL) were replaced by one half of the LLOQ (0.25 ng/mL) in the calculation of the summary statistics. For the Mean score at each visit, if the calculated value was less than 0.5, then "NA" was displayed instead; meaning that the score is below the limit of quantitation (<0.5 ng/mL). | The overall number of participants analyzed includes all randomized participants. The number analyzed per row represents participants with data at each time point. This outcome measure was pre-specified for the brolucizumab arm only. | Posted | Mean | Standard Deviation | ng / mL | pre-dose a baseline, weeks 4, 12, 24, 36, 52, 76 and 104 |
|
|
Adverse events were reported from the start of treatment to 4 weeks after end of treatment, assessed up to maximum duration of 104 weeks.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
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 6mg | Brolucizumab 6mg | 10 | 356 | 75 | 356 | 287 | 356 |
| EG001 | Aflibercept 2mg | Aflibercept 2mg | 4 | 179 | 45 | 179 | 149 | 179 |
| EG002 | Overall | Overall | 14 | 535 | 120 | 535 | 436 | 535 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Acute left ventricular failure | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Angle closure glaucoma - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Anterior chamber cell - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Anterior chamber flare - 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 |
| |
| Glaucoma - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Iridocyclitis - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Neovascular age-related macular degeneration - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Posterior capsule opacification - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Retinal artery occlusion - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Retinal haemorrhage - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Retinal vasculitis - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Retinal vein occlusion - 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 |
| |
| Vitreal cells - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Vitreous haze - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Vitritis - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Gastrointestinal ulcer | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Peptic ulcer haemorrhage | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Drowning | General disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hepatic cyst | Hepatobiliary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Bronchitis | 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 |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Endophthalmitis - Study eye | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Infective exacerbation of bronchiectasis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Postoperative wound 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 |
| |
| Urinary tract infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Corneal abrasion - Study eye | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Postoperative respiratory failure | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Streptococcus test positive - Study eye | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Dehydration | 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 |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
| |
| Bone cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
| |
| Choroid neoplasm - Fellow eye | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
| |
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
| |
| Lung cancer metastatic | 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 |
| |
| Malignant peritoneal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
| |
| Non-small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
| |
| Oropharyngeal squamous cell 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 |
| |
| Renal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Haemorrhagic cerebral infarction | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Seizure | 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 |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Stasis dermatitis | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Shock | 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 |
| |
| Arrhythmia | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine 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 nuclear - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Cataract nuclear - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Cataract subcapsular - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Chalazion - 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 |
| |
| Corneal disorder - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Corneal oedema - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Diabetic retinopathy - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Diplopia - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Dry age-related macular degeneration - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Dry age-related macular degeneration - Study 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 - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Eye pain - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Iridocyclitis - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Iridocyclitis - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Iritis - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Lacrimation increased - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Meibomian gland dysfunction - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Neovascular age-related macular degeneration - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Neovascular age-related macular degeneration - Study 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 |
| |
| Optic disc haemorrhage - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Posterior capsule opacification - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Posterior capsule opacification - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Punctate keratitis - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Punctate keratitis - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Retinal artery embolism - 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 |
| |
| Subretinal fluid - Fellow eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Subretinal fluid - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Uveitis - 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 |
| |
| Vitreal cells - 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 - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Vitritis - Study eye | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system 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 |
| |
| Chorioretinitis - Study eye | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Conjunctivitis - Study eye | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Hordeolum - Fellow eye | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Hordeolum - Study eye | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Pharyngitis | 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 abscess | 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 |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Bone contusion | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Foreign body in eye - Study eye | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Posterior capsule rupture - Study eye | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Blood phosphorus increased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Blood urea 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 |
| |
| Lipase increased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Mean cell volume increased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Monocyte count increased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Optic nerve cup/disc ratio increased - Study eye | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Red blood cell count decreased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Urine analysis abnormal | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hyponatraemia | 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 |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Dupuytren's contracture | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Nerve compression | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast 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 |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | 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 | Apr 30, 2021 | Jun 28, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D016518 | Neurofibromatosis 2 |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D009464 | Neuroma, Acoustic |
| D009442 | Neurilemmoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D017253 | Neurofibromatoses |
| D009455 | Neurofibroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D009463 | Neuroma |
| D009386 | Neoplastic Syndromes, Hereditary |
| D000160 | Vestibulocochlear Nerve Diseases |
| D012181 | Retrocochlear Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010039 | Otorhinolaryngologic Neoplasms |
| D003390 | Cranial Nerve Neoplasms |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D020752 | Neurocutaneous Syndromes |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| C000622091 | brolucizumab |
| C533178 | aflibercept |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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