Choroidal Neovascularization, Neovascular Age-Related Macular Degeneration
Conditions
Keywords
AMD, CNV, IVT
Brief summary
The purpose of this study is to compare brolucizumab (RTH258) ophthalmic solution for intravitreal (IVT) injection (6 mg) to aflibercept ophthalmic solution for IVT injection (2 mg) in subjects with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye.
Detailed description
Subjects were randomized to brolucizumab 6 mg and aflibercept 2 mg in a 1:1 ratio. Subjects in both treatment arms received 3 monthly loading doses (Day 0, Week 4 and Week 8), followed by a maintenance regimen, until the end of the study (Week 96/Exit). All subjects attended pre-specified visits every 4 weeks. Subjects in the brolucizumab 6 mg arm followed a q12w/q8w maintenance regimen. Within the q12w/q8w regimen, the initial treatment after the loading phase was q12w (1 injection every 12 weeks). If disease activity was identified by the masked investigator at any of the disease activity assessments, dosing was adjusted to q8w (1 injection every 8 weeks) (q12w/q8w regimen). Once subjects were adjusted to the q8w interval, they stayed on that interval until the end of the study. Subjects in the aflibercept 2 mg arm followed a q8w maintenance regimen until the end of the study. Results reported up to Week 48 are based on the database locked for the primary analysis at Week 48. Results reported after Week 48 are based on the database locked at the end of study (final analysis).
Interventions
Ophthalmic solution for IVT injection administered as a 6 mg/50 µL dose
Ophthalmic solution for IVT injection administered as a 2 mg/50 µL dose
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Provide written informed consent; * Active CNV lesions secondary to AMD that affected the central subfield in the study eye at Screening; * Total area of CNV \> 50% of the total lesion area in the study eye at Screening; * Intraretinal and/or subretinal fluid affecting the central subfield of the study eye at Screening; * Best corrected visual acuity (BCVA) between 78 and 23 letters, inclusive, in the study eye at Screening and Baseline using Early Treatment Diabetic Retinopathy Study (ETDRS) testing. Key
Exclusion criteria
* Any active intraocular or periocular infection or active intraocular inflammation in either eye at Baseline; * Central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis ≥ 50% of the total lesion in the study eye at Screening; * Subretinal blood affecting the foveal center point and/or ≥ 50% of the lesion of the study eye at Screening; * Any approved or investigational treatment for neovascular age-related macular degeneration (nAMD) in the study eye at any time; * Retinal pigment epithelial rip/tear in the study eye at Screening or Baseline or current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Baseline; * Pregnant or nursing women; women of child-bearing potential; * Stroke or myocardial infarction in the 6-month period prior to Baseline.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) (Letters Read) at Week 48 - Study Eye | Baseline, Week 48 | BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | 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 | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. |
| Proportion of Subjects With Positive q12 (Every 12 Weeks) Treatment Status at Week 48 | Weeks 16, 20, 28, 32, 40, 44, 48 | Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks q12w, after the initial three loading injections every 4 weeks q4w). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44) to identify q8w (one injection every 8 weeks) need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified. |
| Proportion of Subjects With Positive q12 Treatment Status at Week 48 Within the Subjects With no q8 (Every 8 Weeks) Treatment Need During the Initial q12w Cycle (Week 16, Week 20) | Weeks 16, 20, 28, 32, 40, 44, 48 | Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks q12w, after the initial three loading injections every 4 weeks q4w). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified. |
| Proportion of Subjects With Positive q12 Treatment Status up to Week 96 | Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92, 96 | Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks q12w, after the initial three loading injections every 4 weeks q4w). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified. |
| Proportion of Subjects With Positive q12 Treatment Status at Week 96 Within the Subjects With no q8 Treatment Need During the Initial q12w Cycle (Week 16, Week 20) | Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92, 96 | Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks q12w, after the initial three loading injections every 4 weeks q4w). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified. |
| Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | 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 | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. |
| Average Change From Baseline in BCVA (Letters Read) Over the Period Week 4 to Week 48/96 - Study Eye | 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 | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. |
| Average Change From Baseline in BCVA (Letters Read) Over the Period Week 12 to Week 48/96 - Study Eye | Baseline, Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. |
| Average Change From Baseline in BCVA (Letters Read) Over the Period Week 84 to Week 96 - Study Eye | Baseline, Weeks 84, 88, 92, 96 | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. |
| Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | 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 | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. |
| Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | 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 | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. |
| Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | 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 | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. |
| Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | 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 | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. |
| Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | 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 | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. |
| Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | 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 | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly (0-100 letters). A score of 65 to 70 letters represents a low to moderate visual acuity. Baseline was defined as the last measurement prior to first treatment. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. |
| Average Change From Baseline in BCVA (Letters Read) Over the Period Week 36 Through Week 48 - Study Eye | Baseline, Weeks 36, 40, 44, 48 | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. For each subject, this endpoint was defined as the average of the changes from baseline to Weeks 36, 40, 44, and 48. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. |
| Average Change From Baseline in CSFT Over the Period Week 36 Through Week 48 - Study Eye | Baseline, Weeks 36, 40, 44, 48 | CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis. |
| Average Change From Baseline in CSFT Over the Period Week 84 Through Week 96 - Study Eye | Baseline, Weeks 84, 88, 92, 96 | CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis. |
| Average Change From Baseline in CSFT Over the Period Week 4 Through Week 48/96 - Study Eye | 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 | CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis. |
| Change From Baseline in Choroidal Neovascularization (CNV) Lesion Size at Week 12, Week 48, and Week 96 - Study Eye | Baseline, Weeks 12, 48, 96 | CNV lesion size (the area of new blood vessels in the choroid layer of the retina) size was measured using fluorescein angiography (FA). A negative change value indicates a reduction in lesion size, whereas a positive change value indicates an increase. An increase in CNV lesion size may indicate progression of the underlying disease. Only one eye (study eye) contributed to the analysis. |
| Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | 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 | CSFTns was assessed using SD-OCT. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis. |
| Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | 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 | Subretinal fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal fluid is an indicator of underlying disease. One eye (study eye) contributed to the analysis. |
| Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | 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 | Intraretinal fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of intraretinal fluid is an indicator of underlying disease. One eye (study eye) contributed to the analysis. |
| Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | 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 | Sub-retinal pigment epithelium (RPE) fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of sub-RPE fluid is an indicator of underlying disease. One eye (study eye) contributed to the analysis. |
| Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | 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 | Subretinal fluid and intraretinal fluid were assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal and/or intraretinal fluid is an indicator of underlying disease. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. |
| Percentage of Subjects With Disease Activity Present (q8 Treatment Need = Yes) at Week 16 - Study Eye | Week 16 | A disease activity assessment (DAA) was performed to identify q8 treatment need. 95% confidence interval (CI) for binomial proportions is based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. Hypothesis testing not pre-specified. |
| Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Score at Week 24, Week 48, Week 72, and Week 96 | Baseline, Weeks 24, 48, 72, 96 | The National Eye Institute Visual Function Questionnaire-25 (VFQ-25) is a validated questionnaire that collects 25 vision-targeted responses from AMD subjects. The 25 questions pertain to global vision rating (1), difficulty with near vision activities (3), difficulty with distance vision activities (3), limitations in social functioning due to vision (2), role limitations due to vision (2), dependency on others due to vision (3), mental health symptoms due to vision (4), driving difficulties (3), limitations with peripheral (1) and color vision (1), and ocular pain (2). Each response is converted to a 0 to 100 sub-scale, with the lowest and highest possible scores set at 0 and 100 points, respectively. The overall composite score (0 to 100) is obtained by averaging the 25 sub-scale scores. A high score represents better functioning. |
| Percentage of Subjects With Induced or Boosted Anti-drug Antibody (ADA) Status at Week 48 (Brolucizumab Only) | Week 48 | Serum samples were collected and assessed for anti-drug antibody status. Subjects were categorized as ADA negative when one of the following was met: ADA negative at all time points (predose and postdose); ADA negative at predose and no titer values above 10 at all other time points; or ADA titer of 10 at predose but negative at all other time points. ADA induced was defined as ADA negative at predose with postdose titer value greater than or equal to a titer of 30 at any timepoint. ADA boosted was defined as ADA positive at predose with postdose titer values that increased by at least two dilutions (9-fold) from their respective predose value at any time point. |
| Percentage of Subjects With Intraretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye | Baseline, Weeks 12, 48, 96 | Intraretinal hemorrhage was assessed using SD-OCT and recorded as Present/Absent. The presence of intraretinal hemorrhage is an indicator of underlying disease. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. |
| Percentage of Subjects With Subretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye | Baseline, Weeks 12, 48, 96 | Subretinal hemorrhage was assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal hemorrhage is an indicator of underlying disease. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. |
| Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | 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 | CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using Spectral-Domain Optical Coherence Tomography (SD-OCT), a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis. |
Participant flow
Recruitment details
Subjects were recruited from investigative sites located in Austria, Belgium, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, South Korea, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Turkey, UK, and Vietnam.
Pre-assignment details
Of the 1048 subjects enrolled in the study, 305 were exited prior to randomization as screen failures. This reporting group includes all randomized subjects.
Participants by arm
| Arm | Count |
|---|---|
| Brolucizumab 6 mg Single intravitreal (IVT) injection of brolucizumab at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | 370 |
| Aflibercept 2 mg Single IVT injection of aflibercept at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit | 369 |
| Total | 739 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 9 | 4 |
| Overall Study | Death | 4 | 7 |
| Overall Study | Lack of Efficacy | 0 | 2 |
| Overall Study | Lost to Follow-up | 1 | 6 |
| Overall Study | Other | 4 | 1 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 12 | 21 |
Baseline characteristics
| Characteristic | Brolucizumab 6 mg | Aflibercept 2 mg | Total |
|---|---|---|---|
| Age, Continuous | 74.8 years STANDARD_DEVIATION 8.58 | 75.5 years STANDARD_DEVIATION 7.87 | 75.1 years STANDARD_DEVIATION 8.24 |
| Age, Customized 50-64 years | 44 participants | 28 participants | 72 participants |
| Age, Customized 65-74 years | 124 participants | 126 participants | 250 participants |
| Age, Customized 75-84 years | 150 participants | 167 participants | 317 participants |
| Age, Customized 85 years and greater | 52 participants | 48 participants | 100 participants |
| Age, Customized less than 50 years | 0 participants | 0 participants | 0 participants |
| Best Corrected Visual Acuity (BCVA) (letters read) | 61.5 letters STANDARD_DEVIATION 12.59 | 60.8 letters STANDARD_DEVIATION 12.93 | 61.2 letters STANDARD_DEVIATION 12.76 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants | 25 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 321 Participants | 322 Participants | 643 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 26 Participants | 22 Participants | 48 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 22 Participants | 23 Participants | 45 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) White | 340 Participants | 341 Participants | 681 Participants |
| Sex: Female, Male Female | 210 Participants | 212 Participants | 422 Participants |
| Sex: Female, Male Male | 160 Participants | 157 Participants | 317 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 370 | 7 / 369 |
| other Total, other adverse events | 176 / 370 | 194 / 369 |
| serious Total, serious adverse events | 79 / 370 | 89 / 369 |
Outcome results
Primary
Change From Baseline in Best Corrected Visual Acuity (BCVA) (Letters Read) at Week 48 - Study Eye
BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
Time frame: Baseline, Week 48
Population: Full Analysis Set (FAS) - Last Observation Carried Forward (LOCF)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline in Best Corrected Visual Acuity (BCVA) (Letters Read) at Week 48 - Study Eye | 6.9 letters | Standard Deviation 11.47 |
| Aflibercept 2 mg | Change From Baseline in Best Corrected Visual Acuity (BCVA) (Letters Read) at Week 48 - Study Eye | 7.6 letters | Standard Deviation 12.47 |
p-value: <0.000195% CI: [-2.4, 1]ANOVA
Secondary
Average Change From Baseline in BCVA (Letters Read) Over the Period Week 12 to Week 48/96 - Study Eye
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
Time frame: Baseline, Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96
Population: FAS - LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Average Change From Baseline in BCVA (Letters Read) Over the Period Week 12 to Week 48/96 - Study Eye | Change from baseline over the period Week 12 to 48 | 6.1 letters | Standard Deviation 9.91 |
| Brolucizumab 6 mg | Average Change From Baseline in BCVA (Letters Read) Over the Period Week 12 to Week 48/96 - Study Eye | Change from baseline over the period Week 12 to 96 | 6.2 letters | Standard Deviation 10.97 |
| Aflibercept 2 mg | Average Change From Baseline in BCVA (Letters Read) Over the Period Week 12 to Week 48/96 - Study Eye | Change from baseline over the period Week 12 to 48 | 7.2 letters | Standard Deviation 10.77 |
| Aflibercept 2 mg | Average Change From Baseline in BCVA (Letters Read) Over the Period Week 12 to Week 48/96 - Study Eye | Change from baseline over the period Week 12 to 96 | 7.0 letters | Standard Deviation 11.88 |
Comparison: Week 12 to Week 4895% CI: [-2.5, 0.4]ANOVA
Comparison: Week 12 to Week 9695% CI: [-2.4, 0.8]ANOVA
Secondary
Average Change From Baseline in BCVA (Letters Read) Over the Period Week 36 Through Week 48 - Study Eye
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. For each subject, this endpoint was defined as the average of the changes from baseline to Weeks 36, 40, 44, and 48. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
Time frame: Baseline, Weeks 36, 40, 44, 48
Population: FAS - LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brolucizumab 6 mg | Average Change From Baseline in BCVA (Letters Read) Over the Period Week 36 Through Week 48 - Study Eye | 6.6 letters | Standard Deviation 11.1 |
| Aflibercept 2 mg | Average Change From Baseline in BCVA (Letters Read) Over the Period Week 36 Through Week 48 - Study Eye | 7.7 letters | Standard Deviation 11.81 |
p-value: 0.000395% CI: [-2.8, 0.5]ANOVA
Secondary
Average Change From Baseline in BCVA (Letters Read) Over the Period Week 4 to Week 48/96 - Study Eye
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
Time frame: 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
Population: FAS - LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Average Change From Baseline in BCVA (Letters Read) Over the Period Week 4 to Week 48/96 - Study Eye | Change from baseline over the period Week 4 to 48 | 5.8 letters | Standard Deviation 9.11 |
| Brolucizumab 6 mg | Average Change From Baseline in BCVA (Letters Read) Over the Period Week 4 to Week 48/96 - Study Eye | Change from baseline over the period Week 4 to 96 | 6.1 letters | Standard Deviation 10.42 |
| Aflibercept 2 mg | Average Change From Baseline in BCVA (Letters Read) Over the Period Week 4 to Week 48/96 - Study Eye | Change from baseline over the period Week 4 to 48 | 6.9 letters | Standard Deviation 10.11 |
| Aflibercept 2 mg | Average Change From Baseline in BCVA (Letters Read) Over the Period Week 4 to Week 48/96 - Study Eye | Change from baseline over the period Week 4 to 96 | 6.9 letters | Standard Deviation 11.41 |
Comparison: Week 4 to Week 4895% CI: [-2.4, 0.3]ANOVA
Comparison: Week 4 to Week 9695% CI: [-2.4, 0.7]ANOVA
Secondary
Average Change From Baseline in BCVA (Letters Read) Over the Period Week 84 to Week 96 - Study Eye
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
Time frame: Baseline, Weeks 84, 88, 92, 96
Population: FAS - LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brolucizumab 6 mg | Average Change From Baseline in BCVA (Letters Read) Over the Period Week 84 to Week 96 - Study Eye | 6.1 letters | Standard Deviation 13.51 |
| Aflibercept 2 mg | Average Change From Baseline in BCVA (Letters Read) Over the Period Week 84 to Week 96 - Study Eye | 6.7 letters | Standard Deviation 13.96 |
95% CI: [-2.5, 1.4]ANOVA
Secondary
Average Change From Baseline in CSFT Over the Period Week 36 Through Week 48 - Study Eye
CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.
Time frame: Baseline, Weeks 36, 40, 44, 48
Population: FAS - LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brolucizumab 6 mg | Average Change From Baseline in CSFT Over the Period Week 36 Through Week 48 - Study Eye | -187.4 micrometers | Standard Deviation 155.58 |
| Aflibercept 2 mg | Average Change From Baseline in CSFT Over the Period Week 36 Through Week 48 - Study Eye | -159.3 micrometers | Standard Deviation 135.92 |
95% CI: [-54, -18.1]ANOVA
Secondary
Average Change From Baseline in CSFT Over the Period Week 4 Through Week 48/96 - Study Eye
CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.
Time frame: 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
Population: FAS - LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Average Change From Baseline in CSFT Over the Period Week 4 Through Week 48/96 - Study Eye | Change from baseline over the period Week 4 to 48 | -178.7 micrometers | Standard Deviation 145.33 |
| Brolucizumab 6 mg | Average Change From Baseline in CSFT Over the Period Week 4 Through Week 48/96 - Study Eye | Change from baseline over the period Week 4 to 96 | -185.4 micrometers | Standard Deviation 151.35 |
| Aflibercept 2 mg | Average Change From Baseline in CSFT Over the Period Week 4 Through Week 48/96 - Study Eye | Change from baseline over the period Week 4 to 48 | -155.3 micrometers | Standard Deviation 126.83 |
| Aflibercept 2 mg | Average Change From Baseline in CSFT Over the Period Week 4 Through Week 48/96 - Study Eye | Change from baseline over the period Week 4 to 96 | -159.7 micrometers | Standard Deviation 131.74 |
Comparison: Week 4 to Week 4895% CI: [-47.6, -14.1]ANOVA
Comparison: Week 4 to Week 9695% CI: [-50.8, -16.1]ANOVA
Secondary
Average Change From Baseline in CSFT Over the Period Week 84 Through Week 96 - Study Eye
CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.
Time frame: Baseline, Weeks 84, 88, 92, 96
Population: FAS - LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brolucizumab 6 mg | Average Change From Baseline in CSFT Over the Period Week 84 Through Week 96 - Study Eye | -194.3 micrometers | Standard Deviation 161.24 |
| Aflibercept 2 mg | Average Change From Baseline in CSFT Over the Period Week 84 Through Week 96 - Study Eye | -166.2 micrometers | Standard Deviation 142.81 |
95% CI: [-55.1, -17.6]ANOVA
Secondary
Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
Time frame: 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
Population: FAS - LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 28 | 6.3 letters | Standard Deviation 10.97 |
| Brolucizumab 6 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 8 | 5.0 letters | Standard Deviation 8.16 |
| Brolucizumab 6 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 12 | 5.4 letters | Standard Deviation 9.35 |
| Brolucizumab 6 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 16 | 5.4 letters | Standard Deviation 9.65 |
| Brolucizumab 6 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 20 | 5.4 letters | Standard Deviation 10.42 |
| Brolucizumab 6 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 24 | 5.8 letters | Standard Deviation 10.76 |
| Brolucizumab 6 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 4 | 3.7 letters | Standard Deviation 7.03 |
| Brolucizumab 6 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 32 | 6.5 letters | Standard Deviation 10.92 |
| Brolucizumab 6 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 36 | 6.4 letters | Standard Deviation 11.32 |
| Brolucizumab 6 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 40 | 6.4 letters | Standard Deviation 11.66 |
| Brolucizumab 6 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 44 | 6.5 letters | Standard Deviation 11.51 |
| Brolucizumab 6 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 48 | 6.9 letters | Standard Deviation 11.47 |
| Brolucizumab 6 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 52 | 6.8 letters | Standard Deviation 12.03 |
| Brolucizumab 6 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 56 | 6.6 letters | Standard Deviation 12.43 |
| Brolucizumab 6 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 60 | 6.5 letters | Standard Deviation 12.23 |
| Brolucizumab 6 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 64 | 6.5 letters | Standard Deviation 12.51 |
| Brolucizumab 6 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 68 | 6.5 letters | Standard Deviation 12.22 |
| Brolucizumab 6 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 72 | 6.1 letters | Standard Deviation 13.32 |
| Brolucizumab 6 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 76 | 6.3 letters | Standard Deviation 13.44 |
| Brolucizumab 6 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 80 | 6.4 letters | Standard Deviation 13.43 |
| Brolucizumab 6 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 84 | 5.8 letters | Standard Deviation 13.76 |
| Brolucizumab 6 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 88 | 6.3 letters | Standard Deviation 13.4 |
| Brolucizumab 6 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 92 | 6.1 letters | Standard Deviation 13.85 |
| Brolucizumab 6 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 96 | 6.1 letters | Standard Deviation 14.06 |
| Aflibercept 2 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 92 | 6.5 letters | Standard Deviation 14.29 |
| Aflibercept 2 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 4 | 4.7 letters | Standard Deviation 7.62 |
| Aflibercept 2 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 52 | 7.4 letters | Standard Deviation 12.91 |
| Aflibercept 2 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 8 | 6.0 letters | Standard Deviation 9.32 |
| Aflibercept 2 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 76 | 6.8 letters | Standard Deviation 13.8 |
| Aflibercept 2 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 12 | 6.4 letters | Standard Deviation 10.14 |
| Aflibercept 2 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 56 | 7.2 letters | Standard Deviation 13.04 |
| Aflibercept 2 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 16 | 6.3 letters | Standard Deviation 10.46 |
| Aflibercept 2 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 88 | 6.9 letters | Standard Deviation 14.02 |
| Aflibercept 2 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 20 | 6.9 letters | Standard Deviation 10.66 |
| Aflibercept 2 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 60 | 7.4 letters | Standard Deviation 13.49 |
| Aflibercept 2 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 24 | 6.7 letters | Standard Deviation 11.17 |
| Aflibercept 2 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 80 | 6.6 letters | Standard Deviation 13.97 |
| Aflibercept 2 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 28 | 7.4 letters | Standard Deviation 11.86 |
| Aflibercept 2 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 64 | 7.2 letters | Standard Deviation 13.79 |
| Aflibercept 2 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 32 | 7.3 letters | Standard Deviation 11.44 |
| Aflibercept 2 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 96 | 6.6 letters | Standard Deviation 14.55 |
| Aflibercept 2 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 36 | 7.6 letters | Standard Deviation 11.99 |
| Aflibercept 2 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 68 | 7.1 letters | Standard Deviation 14.29 |
| Aflibercept 2 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 40 | 7.6 letters | Standard Deviation 11.85 |
| Aflibercept 2 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 84 | 6.7 letters | Standard Deviation 14.04 |
| Aflibercept 2 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 44 | 8.0 letters | Standard Deviation 12.28 |
| Aflibercept 2 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 72 | 6.9 letters | Standard Deviation 13.74 |
| Aflibercept 2 mg | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 48 | 7.6 letters | Standard Deviation 12.47 |
Comparison: Week 495% CI: [-2, 0]ANOVA
Comparison: Week 895% CI: [-2.2, 0.2]ANOVA
Comparison: Week 1295% CI: [-2.4, 0.4]ANOVA
Comparison: Week 1695% CI: [-2.3, 0.6]ANOVA
Comparison: Week 2095% CI: [-3, 0]ANOVA
Comparison: Week 2495% CI: [-2.5, 0.6]ANOVA
Comparison: Week 2895% CI: [-2.7, 0.5]ANOVA
Comparison: Week 3295% CI: [-2.5, 0.7]ANOVA
Comparison: Week 3695% CI: [-2.9, 0.4]ANOVA
Comparison: Week 4095% CI: [-2.9, 0.5]ANOVA
Comparison: Week 4495% CI: [-3.2, 0.1]ANOVA
Comparison: Week 4895% CI: [-2.4, 1]ANOVA
Comparison: Week 5295% CI: [-2.5, 1.1]ANOVA
Comparison: Week 5695% CI: [-2.5, 1.1]ANOVA
Comparison: Week 6095% CI: [-2.7, 1]ANOVA
Comparison: Week 6495% CI: [-2.5, 1.2]ANOVA
Comparison: Week 6895% CI: [-2.5, 1.2]ANOVA
Comparison: Week 7295% CI: [-2.8, 1.1]ANOVA
Comparison: Week 7695% CI: [-2.5, 1.4]ANOVA
Comparison: Week 8095% CI: [-2.1, 1.8]ANOVA
Comparison: Week 8495% CI: [-2.9, 1.1]ANOVA
Comparison: Week 8895% CI: [-2.6, 1.3]ANOVA
Comparison: Week 9295% CI: [-2.4, 1.6]ANOVA
Comparison: Week 9695% CI: [-2.5, 1.6]ANOVA
Secondary
Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye
CSFTns was assessed using SD-OCT. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.
Time frame: 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
Population: FAS - LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 28 | -56.4 micrometers | Standard Deviation 99.86 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 8 | -55.0 micrometers | Standard Deviation 94.92 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 12 | -52.7 micrometers | Standard Deviation 96.89 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 16 | -50.5 micrometers | Standard Deviation 98.3 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 20 | -49.2 micrometers | Standard Deviation 95.87 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 24 | -53.4 micrometers | Standard Deviation 98.35 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 4 | -51.7 micrometers | Standard Deviation 91.79 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 32 | -49.8 micrometers | Standard Deviation 99.41 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 36 | -59.1 micrometers | Standard Deviation 101.18 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 40 | -55.9 micrometers | Standard Deviation 100.01 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 44 | -56.2 micrometers | Standard Deviation 106.65 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 48 | -54.8 micrometers | Standard Deviation 100.28 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 52 | -58.4 micrometers | Standard Deviation 102.35 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 56 | -57.3 micrometers | Standard Deviation 100.85 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 60 | -60.3 micrometers | Standard Deviation 100.56 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 64 | -58.0 micrometers | Standard Deviation 100.89 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 68 | -56.7 micrometers | Standard Deviation 100.16 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 72 | -58.6 micrometers | Standard Deviation 101.34 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 76 | -59.7 micrometers | Standard Deviation 101.61 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 80 | -57.8 micrometers | Standard Deviation 102.92 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 84 | -60.4 micrometers | Standard Deviation 102.8 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 88 | -59.7 micrometers | Standard Deviation 101.97 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 92 | -60.1 micrometers | Standard Deviation 102 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 96 | -58.9 micrometers | Standard Deviation 102.48 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 92 | -51.0 micrometers | Standard Deviation 91.79 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 4 | -44.2 micrometers | Standard Deviation 80.37 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 52 | -49.1 micrometers | Standard Deviation 90.31 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 8 | -45.4 micrometers | Standard Deviation 84.99 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 76 | -50.2 micrometers | Standard Deviation 91.51 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 12 | -42.4 micrometers | Standard Deviation 85.48 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 56 | -45.8 micrometers | Standard Deviation 91.95 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 16 | -41.2 micrometers | Standard Deviation 84.78 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 88 | -49.1 micrometers | Standard Deviation 94.52 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 20 | -48.1 micrometers | Standard Deviation 88.08 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 60 | -49.3 micrometers | Standard Deviation 90.52 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 24 | -41.8 micrometers | Standard Deviation 90.17 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 80 | -47.6 micrometers | Standard Deviation 92.34 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 28 | -47.3 micrometers | Standard Deviation 87.9 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 64 | -47.5 micrometers | Standard Deviation 92.59 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 32 | -42.0 micrometers | Standard Deviation 90.5 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 96 | -49.4 micrometers | Standard Deviation 94.86 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 36 | -47.8 micrometers | Standard Deviation 89.64 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 68 | -49.5 micrometers | Standard Deviation 91.2 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 40 | -43.2 micrometers | Standard Deviation 91.94 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 84 | -50.6 micrometers | Standard Deviation 92.57 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 44 | -47.1 micrometers | Standard Deviation 90.03 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 72 | -47.3 micrometers | Standard Deviation 92.25 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 48 | -41.8 micrometers | Standard Deviation 93.99 |
Comparison: Week 495% CI: [-11.6, 7.3]ANOVA
Comparison: Week 895% CI: [-13.6, 6]ANOVA
Comparison: Week 1295% CI: [-14.3, 5.3]ANOVA
Comparison: Week 1695% CI: [-13.7, 6.4]ANOVA
Comparison: Week 2095% CI: [-5.5, 14.6]ANOVA
Comparison: Week 2495% CI: [-16.3, 4.7]ANOVA
Comparison: Week 2895% CI: [-13.1, 7]ANOVA
Comparison: Week 3295% CI: [-12.6, 8.5]ANOVA
Comparison: Week 3695% CI: [-15.2, 5.1]ANOVA
Comparison: Week 4095% CI: [-17, 3.8]ANOVA
Comparison: Week 4495% CI: [-13.4, 7.9]ANOVA
Comparison: Week 4895% CI: [-17.6, 3.7]ANOVA
Comparison: Week 5295% CI: [-12.9, 7.5]ANOVA
Comparison: Week 5695% CI: [-15.4, 5.4]ANOVA
Comparison: Week 6095% CI: [-14.3, 5.9]ANOVA
Comparison: Week 6495% CI: [-14.2, 6.4]ANOVA
Comparison: Week 6895% CI: [-10.7, 9.6]ANOVA
Comparison: Week 7295% CI: [-14.8, 5.7]ANOVA
Comparison: Week 7695% CI: [-13.1, 7.4]ANOVA
Comparison: Week 8095% CI: [-14.1, 6.8]ANOVA
Comparison: Week 8495% CI: [-13.5, 7.3]ANOVA
Comparison: Week 8895% CI: [-14.6, 6.5]ANOVA
Comparison: Week 9295% CI: [-12.6, 8]ANOVA
Comparison: Week 9695% CI: [-13.6, 7.7]ANOVA
Secondary
Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye
CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using Spectral-Domain Optical Coherence Tomography (SD-OCT), a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.
Time frame: 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
Population: FAS - LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 36 | -192.6 micrometers | Standard Deviation 156.51 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 16 | -170.9 micrometers | Standard Deviation 152.48 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 20 | -161.0 micrometers | Standard Deviation 151.81 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 24 | -177.8 micrometers | Standard Deviation 150.62 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 28 | -182.7 micrometers | Standard Deviation 156.04 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 32 | -168.9 micrometers | Standard Deviation 157.61 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 12 | -190.5 micrometers | Standard Deviation 148.05 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 40 | -183.4 micrometers | Standard Deviation 156.83 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 44 | -183.8 micrometers | Standard Deviation 161.42 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 48 | -189.8 micrometers | Standard Deviation 158.35 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 52 | -193.8 micrometers | Standard Deviation 157.22 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 56 | -184.9 micrometers | Standard Deviation 162.66 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 60 | -195.4 micrometers | Standard Deviation 161.34 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 64 | -190.9 micrometers | Standard Deviation 160.06 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 68 | -188.4 micrometers | Standard Deviation 161.63 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 72 | -192.3 micrometers | Standard Deviation 160.7 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 76 | -193.1 micrometers | Standard Deviation 162 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 80 | -188.2 micrometers | Standard Deviation 165.9 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 84 | -196.2 micrometers | Standard Deviation 161.97 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 88 | -192.7 micrometers | Standard Deviation 162.46 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 92 | -194.9 micrometers | Standard Deviation 162.35 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 96 | -193.6 micrometers | Standard Deviation 163.97 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 4 | -160.7 micrometers | Standard Deviation 126.55 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 8 | -181.8 micrometers | Standard Deviation 142.11 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 4 | -149.2 micrometers | Standard Deviation 111.6 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 12 | -167.6 micrometers | Standard Deviation 123.66 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 60 | -172.2 micrometers | Standard Deviation 136.58 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 16 | -137.7 micrometers | Standard Deviation 136.76 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 84 | -173.4 micrometers | Standard Deviation 142.11 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 20 | -165.3 micrometers | Standard Deviation 132.7 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 64 | -153.1 micrometers | Standard Deviation 144.45 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 24 | -137.3 micrometers | Standard Deviation 139.32 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 96 | -159.3 micrometers | Standard Deviation 146.26 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 28 | -166.6 micrometers | Standard Deviation 138.22 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 68 | -172.9 micrometers | Standard Deviation 136.76 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 32 | -142.6 micrometers | Standard Deviation 135.87 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 88 | -158.3 micrometers | Standard Deviation 147.24 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 36 | -170.2 micrometers | Standard Deviation 131.42 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 72 | -153.1 micrometers | Standard Deviation 145.02 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 40 | -146.5 micrometers | Standard Deviation 142.69 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 8 | -159.6 micrometers | Standard Deviation 120.93 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 44 | -172.7 micrometers | Standard Deviation 135.06 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 76 | -173.1 micrometers | Standard Deviation 138.96 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 48 | -147.8 micrometers | Standard Deviation 144.97 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 92 | -173.9 micrometers | Standard Deviation 142.3 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 52 | -173.9 micrometers | Standard Deviation 134.84 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 80 | -155.6 micrometers | Standard Deviation 147.09 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 56 | -149.9 micrometers | Standard Deviation 145.37 |
Comparison: Week 495% CI: [-32.6, -2.9]ANOVA
Comparison: Week 895% CI: [-45.6, -13.4]ANOVA
Comparison: Week 1295% CI: [-46.9, -13.7]ANOVA
Comparison: Week 1695% CI: [-58.9, -21.6]ANOVA
Comparison: Week 2095% CI: [-20.9, 15]ANOVA
Comparison: Week 2495% CI: [-66.3, -29.3]ANOVA
Comparison: Week 2895% CI: [-42, -5.4]ANOVA
Comparison: Week 3295% CI: [-52.4, -15]ANOVA
Comparison: Week 3695% CI: [-48, -12.9]ANOVA
Comparison: Week 4095% CI: [-63.5, -25.9]ANOVA
Comparison: Week 4495% CI: [-37.3, -1.1]ANOVA
Comparison: Week 4895% CI: [-68.9, -30.9]ANOVA
Comparison: Week 5295% CI: [-45.8, -10.4]ANOVA
Comparison: Week 5695% CI: [-62.4, -23.7]ANOVA
Comparison: Week 6095% CI: [-49.5, -12.8]ANOVA
Comparison: Week 6495% CI: [-64.9, -26.8]ANOVA
Comparison: Week 6895% CI: [-42, -5.4]ANOVA
Comparison: Week 7295% CI: [-66.4, -28.3]ANOVA
Comparison: Week 7695% CI: [-46.5, -9.5]ANOVA
Comparison: Week 8095% CI: [-60.4, -21.4]ANOVA
Comparison: Week 8495% CI: [-49.6, -12.4]ANOVA
Comparison: Week 8895% CI: [-61.9, -23.3]ANOVA
Comparison: Week 9295% CI: [-47.9, -10.3]ANOVA
Comparison: Week 9695% CI: [-62, -23.3]ANOVA
Secondary
Change From Baseline in Choroidal Neovascularization (CNV) Lesion Size at Week 12, Week 48, and Week 96 - Study Eye
CNV lesion size (the area of new blood vessels in the choroid layer of the retina) size was measured using fluorescein angiography (FA). A negative change value indicates a reduction in lesion size, whereas a positive change value indicates an increase. An increase in CNV lesion size may indicate progression of the underlying disease. Only one eye (study eye) contributed to the analysis.
Time frame: Baseline, Weeks 12, 48, 96
Population: FAS - LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline in Choroidal Neovascularization (CNV) Lesion Size at Week 12, Week 48, and Week 96 - Study Eye | Change from baseline at Week 12 | -2.2 millimeters squared | Standard Deviation 2.71 |
| Brolucizumab 6 mg | Change From Baseline in Choroidal Neovascularization (CNV) Lesion Size at Week 12, Week 48, and Week 96 - Study Eye | Change from baseline at Week 48 | -2.3 millimeters squared | Standard Deviation 2.76 |
| Brolucizumab 6 mg | Change From Baseline in Choroidal Neovascularization (CNV) Lesion Size at Week 12, Week 48, and Week 96 - Study Eye | Change from baseline at Week 96 | -2.5 millimeters squared | Standard Deviation 2.77 |
| Aflibercept 2 mg | Change From Baseline in Choroidal Neovascularization (CNV) Lesion Size at Week 12, Week 48, and Week 96 - Study Eye | Change from baseline at Week 12 | -2.5 millimeters squared | Standard Deviation 4.02 |
| Aflibercept 2 mg | Change From Baseline in Choroidal Neovascularization (CNV) Lesion Size at Week 12, Week 48, and Week 96 - Study Eye | Change from baseline at Week 48 | -2.5 millimeters squared | Standard Deviation 4.04 |
| Aflibercept 2 mg | Change From Baseline in Choroidal Neovascularization (CNV) Lesion Size at Week 12, Week 48, and Week 96 - Study Eye | Change from baseline at Week 96 | -2.7 millimeters squared | Standard Deviation 4.03 |
Comparison: Week 1295% CI: [0, 0.7]ANOVA
Comparison: Week 4895% CI: [-0.1, 0.6]ANOVA
Comparison: Week 9695% CI: [0, 0.6]ANOVA
Secondary
Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Score at Week 24, Week 48, Week 72, and Week 96
The National Eye Institute Visual Function Questionnaire-25 (VFQ-25) is a validated questionnaire that collects 25 vision-targeted responses from AMD subjects. The 25 questions pertain to global vision rating (1), difficulty with near vision activities (3), difficulty with distance vision activities (3), limitations in social functioning due to vision (2), role limitations due to vision (2), dependency on others due to vision (3), mental health symptoms due to vision (4), driving difficulties (3), limitations with peripheral (1) and color vision (1), and ocular pain (2). Each response is converted to a 0 to 100 sub-scale, with the lowest and highest possible scores set at 0 and 100 points, respectively. The overall composite score (0 to 100) is obtained by averaging the 25 sub-scale scores. A high score represents better functioning.
Time frame: Baseline, Weeks 24, 48, 72, 96
Population: FAS - Observed. Number analyzed is the number of subjects with a value for both baseline and the specific post-baseline visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Score at Week 24, Week 48, Week 72, and Week 96 | Change from baseline at Week 24 | 3.9 score on a scale | Standard Deviation 10.09 |
| Brolucizumab 6 mg | Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Score at Week 24, Week 48, Week 72, and Week 96 | Change from baseline at Week 72 | 5.0 score on a scale | Standard Deviation 13.38 |
| Brolucizumab 6 mg | Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Score at Week 24, Week 48, Week 72, and Week 96 | Change from baseline at Week 48 | 4.8 score on a scale | Standard Deviation 11.57 |
| Brolucizumab 6 mg | Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Score at Week 24, Week 48, Week 72, and Week 96 | Change from baseline at Week 96 | 3.8 score on a scale | Standard Deviation 14.06 |
| Aflibercept 2 mg | Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Score at Week 24, Week 48, Week 72, and Week 96 | Change from baseline at Week 96 | 2.6 score on a scale | Standard Deviation 13.11 |
| Aflibercept 2 mg | Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Score at Week 24, Week 48, Week 72, and Week 96 | Change from baseline at Week 24 | 3.5 score on a scale | Standard Deviation 10.95 |
| Aflibercept 2 mg | Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Score at Week 24, Week 48, Week 72, and Week 96 | Change from baseline at Week 48 | 3.6 score on a scale | Standard Deviation 11.88 |
| Aflibercept 2 mg | Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Score at Week 24, Week 48, Week 72, and Week 96 | Change from baseline at Week 72 | 3.2 score on a scale | Standard Deviation 12.3 |
Secondary
Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
Time frame: 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
Population: FAS - LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 8 | 26.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 52 | 44.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 28 | 40.3 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 56 | 43.0 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 16 | 36.5 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 60 | 42.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 32 | 41.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 64 | 44.3 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 4 | 20.0 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 68 | 43.5 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 36 | 40.3 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 72 | 41.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 20 | 33.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 76 | 45.4 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 40 | 43.5 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 80 | 43.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 12 | 32.4 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 84 | 40.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 44 | 42.4 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 88 | 43.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 24 | 35.7 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 92 | 45.4 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 96 | 45.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 48 | 44.1 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 60 | 44.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 4 | 22.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 8 | 32.8 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 12 | 36.0 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 16 | 36.9 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 20 | 38.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 24 | 39.3 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 28 | 42.5 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 32 | 43.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 36 | 45.5 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 40 | 46.3 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 44 | 45.3 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 48 | 45.8 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 52 | 45.8 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 56 | 45.5 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 92 | 43.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 64 | 45.8 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 68 | 45.0 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 72 | 44.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 76 | 44.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 80 | 44.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 84 | 44.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 88 | 45.5 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 96 | 45.0 percentage of subjects |
Comparison: Week 495% CI: [-7.6, 3.8]Regression, Logistic
Comparison: Week 895% CI: [-13, 0.1]Regression, Logistic
Comparison: Week 1295% CI: [-10.1, 2.4]Regression, Logistic
Comparison: Week 1695% CI: [-7.3, 6.3]Regression, Logistic
Comparison: Week 2095% CI: [-11.2, 2.2]Regression, Logistic
Comparison: Week 2495% CI: [-10.7, 3]Regression, Logistic
Comparison: Week 2895% CI: [-9.6, 4]Regression, Logistic
Comparison: Week 3295% CI: [-9.4, 4.5]Regression, Logistic
Comparison: Week 3695% CI: [-12.1, 1.1]Regression, Logistic
Comparison: Week 4095% CI: [-9.9, 3.5]Regression, Logistic
Comparison: Week 4495% CI: [-10.3, 4.2]Regression, Logistic
Comparison: Week 4895% CI: [-8.7, 4.7]Regression, Logistic
Comparison: Week 5295% CI: [-8, 5.7]Regression, Logistic
Comparison: Week 5695% CI: [-9.8, 4.3]Regression, Logistic
Comparison: Week 6095% CI: [-9.6, 4.2]Regression, Logistic
Comparison: Week 6495% CI: [-8.8, 5.4]Regression, Logistic
Comparison: Week 6895% CI: [-8.4, 5]Regression, Logistic
Comparison: Week 7295% CI: [-10.4, 2.9]Regression, Logistic
Comparison: Week 7695% CI: [-6.5, 7.2]Regression, Logistic
Comparison: Week 8095% CI: [-7.5, 6.1]Regression, Logistic
Comparison: Week 8495% CI: [-10.4, 3.1]Regression, Logistic
Comparison: Week 8895% CI: [-9.6, 3.9]Regression, Logistic
Comparison: Week 9295% CI: [-5, 8.3]Regression, Logistic
Comparison: Week 9695% CI: [-7, 6.8]Regression, Logistic
Secondary
Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
Time frame: 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
Population: FAS - LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 52 | 8.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 8 | 2.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 56 | 9.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 28 | 5.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 60 | 8.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 16 | 3.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 64 | 8.4 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 32 | 5.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 68 | 7.6 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 4 | 1.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 72 | 7.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 36 | 6.5 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 76 | 9.5 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 20 | 5.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 80 | 9.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 40 | 7.0 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 84 | 9.5 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 44 | 8.6 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 88 | 8.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 12 | 2.7 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 92 | 9.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 48 | 6.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 96 | 9.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 24 | 5.1 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 96 | 10.3 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 4 | 2.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 8 | 2.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 12 | 3.0 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 16 | 5.1 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 20 | 4.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 24 | 6.0 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 28 | 5.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 32 | 6.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 36 | 6.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 44 | 6.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 48 | 7.3 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 52 | 7.3 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 56 | 8.1 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 60 | 7.3 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 64 | 8.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 68 | 8.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 72 | 8.1 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 76 | 9.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 80 | 10.0 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 84 | 9.5 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 88 | 9.8 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 92 | 11.1 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 40 | 6.0 percentage of subjects |
Comparison: Week 8095% CI: [-4.5, 3.4]Regression, Logistic
Comparison: Week 495% CI: [-2.6, 1.6]Regression, Logistic
Comparison: Week 895% CI: [-2.2, 2.1]Regression, Logistic
Comparison: Week 1295% CI: [-2.8, 2.2]Regression, Logistic
Comparison: Week 1695% CI: [-4.4, 1.7]Regression, Logistic
Comparison: Week 2095% CI: [-1.7, 4.9]Regression, Logistic
Comparison: Week 2495% CI: [-3.9, 2.8]Regression, Logistic
Comparison: Week 2895% CI: [-3.2, 3.8]Regression, Logistic
Comparison: Week 3295% CI: [-3.8, 3.5]Regression, Logistic
Comparison: Week 3695% CI: [-3, 4.2]Regression, Logistic
Comparison: Week 4095% CI: [-2.4, 5.1]Regression, Logistic
Comparison: Week 4495% CI: [-1.1, 6.5]Regression, Logistic
Comparison: Week 4895% CI: [-4, 3.3]Regression, Logistic
Comparison: Week 5295% CI: [-2.8, 4.7]Regression, Logistic
Comparison: Week 5695% CI: [-2.8, 5.5]Regression, Logistic
Comparison: Week 6095% CI: [-2.6, 4.7]Regression, Logistic
Comparison: Week 6495% CI: [-4, 4.3]Regression, Logistic
Comparison: Week 6895% CI: [-4.2, 3.6]Regression, Logistic
Comparison: Week 7295% CI: [-4, 3.7]Regression, Logistic
Comparison: Week 7695% CI: [-3.5, 4.7]Regression, Logistic
Comparison: Week 8495% CI: [-3.6, 4.5]Regression, Logistic
Comparison: Week 8895% CI: [-4.5, 3.6]Regression, Logistic
Comparison: Week 9295% CI: [-5.7, 2.6]Regression, Logistic
Comparison: Week 9695% CI: [-4.9, 3.2]Regression, Logistic
Secondary
Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
Time frame: 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
Population: FAS - LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 28 | 23.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 8 | 13.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 12 | 16.5 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 16 | 20.0 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 20 | 20.5 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 24 | 23.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 4 | 7.6 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 32 | 25.4 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 36 | 26.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 40 | 27.0 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 44 | 26.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 48 | 29.5 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 52 | 30.3 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 56 | 29.7 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 60 | 28.6 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 64 | 29.7 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 68 | 28.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 72 | 27.6 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 76 | 28.4 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 80 | 28.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 84 | 27.6 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 88 | 27.6 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 92 | 29.5 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 96 | 29.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 92 | 30.9 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 4 | 8.9 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 52 | 30.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 8 | 18.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 76 | 30.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 12 | 21.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 56 | 30.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 16 | 22.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 88 | 33.1 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 20 | 23.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 60 | 30.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 24 | 22.8 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 80 | 30.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 28 | 27.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 64 | 30.9 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 32 | 28.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 96 | 31.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 36 | 30.9 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 68 | 32.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 40 | 31.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 84 | 31.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 44 | 31.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 72 | 31.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 48 | 29.8 percentage of subjects |
Comparison: Week 495% CI: [-5.1, 2.9]Regression, Logistic
Comparison: Week 895% CI: [-9.5, 1]Regression, Logistic
Comparison: Week 1295% CI: [-10.5, 0.3]Regression, Logistic
Comparison: Week 1695% CI: [-8.4, 3.7]Regression, Logistic
Comparison: Week 2095% CI: [-8.8, 2.8]Regression, Logistic
Comparison: Week 2495% CI: [-5.2, 6.7]Regression, Logistic
Comparison: Week 2895% CI: [-9.9, 2.3]Regression, Logistic
Comparison: Week 3295% CI: [-10.5, 2.7]Regression, Logistic
Comparison: Week 3695% CI: [-11.6, 1.3]Regression, Logistic
Comparison: Week 4095% CI: [-11.5, 1.9]Regression, Logistic
Comparison: Week 4495% CI: [-11.3, 1.8]Regression, Logistic
Comparison: Week 4895% CI: [-7.1, 5.8]Regression, Logistic
Comparison: Week 5295% CI: [-7, 5.5]Regression, Logistic
Comparison: Week 5695% CI: [-7.7, 5.4]Regression, Logistic
Comparison: Week 6095% CI: [-8.3, 4.2]Regression, Logistic
Comparison: Week 6495% CI: [-7.9, 5.4]Regression, Logistic
Comparison: Week 6895% CI: [-9.9, 3.1]Regression, Logistic
Comparison: Week 7295% CI: [-10.2, 2.3]Regression, Logistic
Comparison: Week 7695% CI: [-8.8, 4]Regression, Logistic
Comparison: Week 8095% CI: [-9, 3.5]Regression, Logistic
Comparison: Week 8495% CI: [-9.9, 2.8]Regression, Logistic
Comparison: Week 8895% CI: [-11.8, 0.3]Regression, Logistic
Comparison: Week 9295% CI: [-7.9, 4.5]Regression, Logistic
Comparison: Week 9695% CI: [-8.8, 4.1]Regression, Logistic
Secondary
Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
Time frame: 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
Population: FAS - LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 28 | 3.0 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 8 | 1.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 12 | 1.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 16 | 2.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 20 | 3.5 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 24 | 2.7 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 4 | 1.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 32 | 3.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 36 | 3.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 40 | 5.4 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 44 | 4.6 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 48 | 3.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 52 | 4.6 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 56 | 5.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 60 | 6.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 64 | 6.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 68 | 5.4 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 72 | 7.3 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 76 | 6.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 80 | 7.0 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 84 | 7.3 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 88 | 6.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 92 | 7.0 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 96 | 7.0 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 92 | 7.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 4 | 1.1 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 52 | 5.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 8 | 1.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 76 | 6.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 12 | 1.9 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 56 | 5.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 16 | 2.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 88 | 7.0 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 20 | 3.0 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 60 | 5.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 24 | 3.3 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 80 | 6.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 28 | 3.5 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 64 | 6.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 32 | 3.8 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 96 | 7.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 36 | 3.5 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 68 | 6.5 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 40 | 4.3 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 84 | 7.3 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 44 | 4.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 72 | 6.5 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 48 | 4.9 percentage of subjects |
Comparison: Week 495% CI: [-1.6, 1.4]Regression, Logistic
Comparison: Week 895% CI: [-2.3, 1.1]Regression, Logistic
Comparison: Week 1295% CI: [-1.9, 2.2]Regression, Logistic
Comparison: Week 1695% CI: [-2.1, 2.3]Regression, Logistic
Comparison: Week 2095% CI: [-2, 3.3]Regression, Logistic
Comparison: Week 2495% CI: [-3, 2.2]Regression, Logistic
Comparison: Week 2895% CI: [-3, 2.3]Regression, Logistic
Comparison: Week 3295% CI: [-3.2, 2.5]Regression, Logistic
Comparison: Week 3695% CI: [-2.3, 3.3]Regression, Logistic
Comparison: Week 4095% CI: [-1.7, 4.6]Regression, Logistic
Comparison: Week 4495% CI: [-2.7, 3.4]Regression, Logistic
Comparison: Week 4895% CI: [-3.9, 2.2]Regression, Logistic
Comparison: Week 5295% CI: [-4.3, 2.3]Regression, Logistic
Comparison: Week 5695% CI: [-2.8, 3.9]Regression, Logistic
Comparison: Week 6095% CI: [-2.5, 4.2]Regression, Logistic
Comparison: Week 6495% CI: [-2.7, 4.5]Regression, Logistic
Comparison: Week 6895% CI: [-4.2, 2.6]Regression, Logistic
Comparison: Week 7295% CI: [-2.5, 4.5]Regression, Logistic
Comparison: Week 7695% CI: [-2.5, 4.4]Regression, Logistic
Comparison: Week 8095% CI: [-2.4, 4.6]Regression, Logistic
Comparison: Week 8495% CI: [-3.1, 4.1]Regression, Logistic
Comparison: Week 8895% CI: [-3.5, 3.6]Regression, Logistic
Comparison: Week 9295% CI: [-3.8, 3.3]Regression, Logistic
Comparison: Week 9695% CI: [-3.8, 3.3]Regression, Logistic
Secondary
Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
Time frame: 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
Population: FAS - LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 28 | 60.0 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 52 | 63.0 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 12 | 55.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 56 | 62.7 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 32 | 64.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 60 | 62.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 20 | 55.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 64 | 65.7 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 36 | 63.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 68 | 62.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 72 | 63.0 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 8 | 50.0 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 76 | 63.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 40 | 63.0 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 80 | 65.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 24 | 58.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 84 | 61.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 44 | 64.6 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 88 | 63.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 16 | 55.4 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 92 | 64.6 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 48 | 64.6 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 96 | 64.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 4 | 41.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 96 | 60.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 68 | 63.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 4 | 45.3 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 8 | 53.1 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 12 | 58.5 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 16 | 56.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 20 | 61.0 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 24 | 61.0 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 28 | 65.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 32 | 65.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 36 | 65.3 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 40 | 64.0 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 44 | 65.9 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 48 | 64.5 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 52 | 65.3 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 56 | 64.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 60 | 62.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 64 | 63.1 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 72 | 61.5 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 76 | 61.5 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 80 | 60.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 84 | 64.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 88 | 62.1 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 92 | 60.7 percentage of subjects |
Comparison: Week 495% CI: [-10.4, 3.6]Regression, Logistic
Comparison: Week 895% CI: [-10.2, 3.7]Regression, Logistic
Comparison: Week 1295% CI: [-10.7, 3.3]Regression, Logistic
Comparison: Week 1695% CI: [-8.4, 5.7]Regression, Logistic
Comparison: Week 2095% CI: [-12.3, 1.5]Regression, Logistic
Comparison: Week 2495% CI: [-9.9, 3.7]Regression, Logistic
Comparison: Week 2895% CI: [-12.8, 0.7]Regression, Logistic
Comparison: Week 3295% CI: [-8.2, 4.8]Regression, Logistic
Comparison: Week 3695% CI: [-9.2, 4.2]Regression, Logistic
Comparison: Week 4095% CI: [-8.2, 5.6]Regression, Logistic
Comparison: Week 4495% CI: [-8.5, 5]Regression, Logistic
Comparison: Week 4895% CI: [-7.4, 6.2]Regression, Logistic
Comparison: Week 5295% CI: [-9.8, 4]Regression, Logistic
Comparison: Week 5695% CI: [-8.6, 4.8]Regression, Logistic
Comparison: Week 6095% CI: [-7.8, 6.1]Regression, Logistic
Comparison: Week 6495% CI: [-4.5, 9.2]Regression, Logistic
Comparison: Week 6895% CI: [-8.6, 4.9]Regression, Logistic
Comparison: Week 7295% CI: [-5.8, 7.5]Regression, Logistic
Comparison: Week 7695% CI: [-5.1, 8.4]Regression, Logistic
Comparison: Week 8095% CI: [-2.8, 10.9]Regression, Logistic
Comparison: Week 8495% CI: [-9.3, 4.1]Regression, Logistic
Comparison: Week 8895% CI: [-6.1, 7.7]Regression, Logistic
Comparison: Week 9295% CI: [-3, 10.4]Regression, Logistic
Comparison: Week 9695% CI: [-3.9, 10]Regression, Logistic
Secondary
Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
Time frame: 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
Population: FAS - LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 8 | 7.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 52 | 13.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 28 | 11.4 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 56 | 13.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 16 | 10.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 32 | 12.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 64 | 12.7 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 4 | 6.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 68 | 13.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 36 | 12.7 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 72 | 14.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 20 | 11.6 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 76 | 14.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 40 | 11.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 80 | 13.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 12 | 8.4 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 84 | 14.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 44 | 11.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 88 | 13.0 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 24 | 13.0 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 92 | 14.3 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 48 | 11.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 96 | 14.3 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 60 | 12.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 96 | 14.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 4 | 6.5 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 8 | 8.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 12 | 9.5 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 16 | 8.9 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 20 | 8.1 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 24 | 10.0 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 28 | 8.9 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 32 | 11.1 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 36 | 9.5 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 40 | 11.1 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 44 | 9.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 48 | 11.9 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 52 | 11.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 56 | 11.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 60 | 11.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 64 | 12.5 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 68 | 12.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 72 | 13.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 76 | 13.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 80 | 15.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 84 | 14.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 88 | 14.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye | Change from baseline at Week 92 | 16.0 percentage of subjects |
Comparison: Week 495% CI: [-3.5, 3.5]Regression, Logistic
Comparison: Week 895% CI: [-4.4, 3.4]Regression, Logistic
Comparison: Week 1295% CI: [-5, 3.1]Regression, Logistic
Comparison: Week 1695% CI: [-1.9, 6.2]Regression, Logistic
Comparison: Week 2095% CI: [-0.4, 7.8]Regression, Logistic
Comparison: Number of subjects with \>=5 letter loss from baseline in BCVA (letters read) at each post-baseline visit - Week 2495% CI: [-1.3, 7.8]Regression, Logistic
Comparison: Week 2895% CI: [-1.7, 7.3]Regression, Logistic
Comparison: Week 3295% CI: [-3.2, 5.9]Regression, Logistic
Comparison: Week 3695% CI: [-0.7, 8.3]Regression, Logistic
Comparison: Week 4095% CI: [-3.8, 5.6]Regression, Logistic
Comparison: Week 4495% CI: [-1.4, 7]Regression, Logistic
Comparison: Week 4895% CI: [-5.1, 3.7]Regression, Logistic
Comparison: Week 5295% CI: [-2.5, 6.7]Regression, Logistic
Comparison: Week 5695% CI: [-2.8, 6.4]Regression, Logistic
Comparison: Week 6095% CI: [-3.6, 5.8]Regression, Logistic
Comparison: Week 6495% CI: [-4, 5.4]Regression, Logistic
Comparison: Week 6895% CI: [-2.8, 6.4]Regression, Logistic
Comparison: Week 7295% CI: [-4.3, 5.7]Regression, Logistic
Comparison: Week 7695% CI: [-4.4, 5.8]Regression, Logistic
Comparison: Week 8095% CI: [-6, 3.6]Regression, Logistic
Comparison: Week 8495% CI: [-5.2, 4.5]Regression, Logistic
Comparison: Week 8895% CI: [-5.7, 3.6]Regression, Logistic
Comparison: Week 9295% CI: [-6.5, 3.4]Regression, Logistic
Comparison: Week 9695% CI: [-5.1, 4.8]Regression, Logistic
Secondary
Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly (0-100 letters). A score of 65 to 70 letters represents a low to moderate visual acuity. Baseline was defined as the last measurement prior to first treatment. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
Time frame: 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
Population: FAS - LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 4 | 31.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 52 | 49.7 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 24 | 45.4 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 56 | 50.5 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 28 | 48.6 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 60 | 48.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 12 | 43.5 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 64 | 49.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 32 | 47.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 68 | 48.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Baseline | 21.4 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 72 | 48.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 36 | 47.6 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 76 | 48.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 16 | 44.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 80 | 51.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 40 | 48.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 84 | 48.4 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 8 | 40.3 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 88 | 50.5 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 44 | 50.3 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 92 | 50.5 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 20 | 44.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 96 | 48.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 48 | 51.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 96 | 49.1 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Baseline | 17.9 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 4 | 34.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 8 | 41.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 12 | 44.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 16 | 42.5 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 20 | 45.0 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 28 | 50.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 32 | 49.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 36 | 49.9 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 40 | 49.3 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 44 | 50.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 48 | 49.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 52 | 50.1 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 56 | 50.9 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 60 | 52.3 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 64 | 50.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 68 | 50.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 72 | 49.3 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 76 | 49.9 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 80 | 50.1 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 84 | 49.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 88 | 50.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 92 | 49.9 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye | Week 24 | 47.4 percentage of subjects |
Comparison: Week 495% CI: [-9.2, 1.6]Regression, Logistic
Comparison: Week 895% CI: [-8.1, 3.7]Regression, Logistic
Comparison: Week 1295% CI: [-8.4, 3.5]Regression, Logistic
Comparison: Week 1695% CI: [-5.4, 6.7]Regression, Logistic
Comparison: Week 2095% CI: [-8.2, 4]Regression, Logistic
Comparison: Week 2495% CI: [-9, 3.3]Regression, Logistic
Comparison: Week 2895% CI: [-9.3, 2.5]Regression, Logistic
Comparison: Week 3295% CI: [-9.6, 2.8]Regression, Logistic
Comparison: Week 3695% CI: [-9.6, 2.2]Regression, Logistic
Comparison: Week 4095% CI: [-7.6, 4.2]Regression, Logistic
Comparison: Week 4495% CI: [-7.5, 5]Regression, Logistic
Comparison: Week 4895% CI: [-5.4, 6.1]Regression, Logistic
Comparison: Week 5295% CI: [-7.7, 4.5]Regression, Logistic
Comparison: Week 5695% CI: [-7.7, 4]Regression, Logistic
Comparison: Week 6095% CI: [-10.8, 1.4]Regression, Logistic
Comparison: Week 6495% CI: [-8.9, 3.2]Regression, Logistic
Comparison: Week 6895% CI: [-9.5, 2.9]Regression, Logistic
Comparison: Week 7295% CI: [-7.9, 4.5]Regression, Logistic
Comparison: Week 7695% CI: [-8.1, 4.1]Regression, Logistic
Comparison: Week 8095% CI: [-5.6, 6.6]Regression, Logistic
Comparison: Week 8495% CI: [-8.3, 3.8]Regression, Logistic
Comparison: Week 8895% CI: [-7.4, 4.5]Regression, Logistic
Comparison: Week 9295% CI: [-6.5, 5.8]Regression, Logistic
Comparison: Week 9695% CI: [-8.1, 4.1]Regression, Logistic
Secondary
Percentage of Subjects With Disease Activity Present (q8 Treatment Need = Yes) at Week 16 - Study Eye
A disease activity assessment (DAA) was performed to identify q8 treatment need. 95% confidence interval (CI) for binomial proportions is based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. Hypothesis testing not pre-specified.
Time frame: Week 16
Population: FAS - 'efficacy/safety' approach. Censored data attributable to lack of efficacy and/or safety are imputed with q8w need = Yes at the next disease activity assessment visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brolucizumab 6 mg | Percentage of Subjects With Disease Activity Present (q8 Treatment Need = Yes) at Week 16 - Study Eye | 22.8 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Disease Activity Present (q8 Treatment Need = Yes) at Week 16 - Study Eye | 32.1 percentage of subjects |
Secondary
Percentage of Subjects With Induced or Boosted Anti-drug Antibody (ADA) Status at Week 48 (Brolucizumab Only)
Serum samples were collected and assessed for anti-drug antibody status. Subjects were categorized as ADA negative when one of the following was met: ADA negative at all time points (predose and postdose); ADA negative at predose and no titer values above 10 at all other time points; or ADA titer of 10 at predose but negative at all other time points. ADA induced was defined as ADA negative at predose with postdose titer value greater than or equal to a titer of 30 at any timepoint. ADA boosted was defined as ADA positive at predose with postdose titer values that increased by at least two dilutions (9-fold) from their respective predose value at any time point.
Time frame: Week 48
Population: Safety Analysis Set - Observed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brolucizumab 6 mg | Percentage of Subjects With Induced or Boosted Anti-drug Antibody (ADA) Status at Week 48 (Brolucizumab Only) | 18.8 percentage of subjects |
Secondary
Percentage of Subjects With Intraretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye
Intraretinal hemorrhage was assessed using SD-OCT and recorded as Present/Absent. The presence of intraretinal hemorrhage is an indicator of underlying disease. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
Time frame: Baseline, Weeks 12, 48, 96
Population: FAS with non-missing values. Number Analyzed represents the number of subjects with a value for both baseline and the specific post-baseline visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | Percentage of Subjects With Intraretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye | Week 48 | 4.0 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Intraretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye | Week 12 | 6.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Intraretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye | Week 96 | 2.1 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Intraretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye | Week 12 | 6.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Intraretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye | Week 48 | 5.0 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Intraretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye | Week 96 | 2.7 percentage of subjects |
Secondary
Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Intraretinal fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of intraretinal fluid is an indicator of underlying disease. One eye (study eye) contributed to the analysis.
Time frame: 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
Population: FAS - LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 24 | 10.5 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 52 | 9.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 12 | 7.6 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 56 | 13.0 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 28 | 9.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 60 | 8.4 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 68 | 11.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 64 | 10.3 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 32 | 14.3 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 16 | 12.7 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 72 | 11.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 36 | 7.0 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 76 | 9.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 8 | 7.0 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 80 | 12.4 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 20 | 16.5 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 84 | 10.5 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 44 | 12.4 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 88 | 10.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 4 | 10.3 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 92 | 10.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 48 | 11.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 96 | 10.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 40 | 13.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 96 | 10.3 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 4 | 8.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 8 | 8.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 12 | 8.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 16 | 11.9 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 20 | 7.9 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 24 | 13.0 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 28 | 6.0 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 32 | 14.1 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 36 | 8.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 40 | 13.8 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 44 | 8.1 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 48 | 12.5 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 52 | 7.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 56 | 13.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 60 | 8.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 64 | 11.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 68 | 8.1 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 72 | 10.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 76 | 8.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 80 | 12.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 84 | 9.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 88 | 10.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye | Week 92 | 6.8 percentage of subjects |
Comparison: Week 4095% CI: [-6, 3.1]Regression, Logistic
Comparison: Week 2895% CI: [-1, 6.4]Regression, Logistic
Comparison: Week 3295% CI: [-5.5, 4]Regression, Logistic
Comparison: Week 3695% CI: [-5.6, 1.8]Regression, Logistic
Comparison: Week 495% CI: [-2.5, 5.4]Regression, Logistic
Comparison: Week 895% CI: [-6.1, 1.7]Regression, Logistic
Comparison: Week 1295% CI: [-5.3, 2.2]Regression, Logistic
Comparison: Week 1695% CI: [-4.5, 4.4]Regression, Logistic
Comparison: Week 2095% CI: [3.9, 12.8]Regression, Logistic
Comparison: Week 2495% CI: [-7.9, 1.2]Regression, Logistic
Comparison: Week 4495% CI: [-0.5, 8]Regression, Logistic
Comparison: Week 4895% CI: [-6.2, 2.2]Regression, Logistic
Comparison: Week 5295% CI: [-2.5, 5.1]Regression, Logistic
Comparison: Week 5695% CI: [-5.9, 3.1]Regression, Logistic
Comparison: Week 6095% CI: [-4.4, 3.4]Regression, Logistic
Comparison: Week 6495% CI: [-6.2, 2.1]Regression, Logistic
Comparison: Week 6895% CI: [-1.2, 6.5]Regression, Logistic
Comparison: Week 7295% CI: [-4.2, 4.3]Regression, Logistic
Comparison: Week 7695% CI: [-3.5, 4.2]Regression, Logistic
Comparison: Week 8095% CI: [-4.8, 4.3]Regression, Logistic
Comparison: Week 8495% CI: [-3.3, 5.2]Regression, Logistic
Comparison: Week 8895% CI: [-4.5, 3.9]Regression, Logistic
Comparison: Week 9295% CI: [-0.1, 8]Regression, Logistic
Comparison: Week 9695% CI: [-4.3, 4.6]Regression, Logistic
Secondary
Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye
Subretinal fluid and intraretinal fluid were assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal and/or intraretinal fluid is an indicator of underlying disease. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
Time frame: 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
Population: FAS - LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 52 | 27.0 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 12 | 19.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 56 | 34.3 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 16 | 29.7 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 60 | 26.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 40 | 28.4 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 64 | 28.4 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 24 | 25.7 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 68 | 31.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 20 | 37.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 72 | 27.0 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 28 | 23.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 76 | 29.5 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 48 | 25.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 80 | 32.7 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 32 | 34.6 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 84 | 27.3 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 8 | 20.3 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 88 | 28.4 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 36 | 19.5 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 92 | 25.7 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 44 | 33.0 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 96 | 24.6 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 4 | 35.9 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 96 | 38.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 8 | 29.3 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 20 | 29.8 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 36 | 28.5 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 40 | 44.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 48 | 43.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 12 | 27.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 16 | 44.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 24 | 45.3 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 28 | 27.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 32 | 43.9 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 44 | 29.3 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 52 | 29.5 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 56 | 43.1 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 60 | 32.0 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 64 | 43.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 68 | 30.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 72 | 41.5 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 76 | 29.8 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 80 | 42.5 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 84 | 31.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 88 | 38.8 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 92 | 28.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye | Week 4 | 42.8 percentage of subjects |
Comparison: Week 495% CI: [-14.2, 0.2]Regression, Logistic
Comparison: Week 895% CI: [-15.5, -2.5]Regression, Logistic
Comparison: Week 1295% CI: [-15, -2.6]Regression, Logistic
Comparison: Week 1695% CI: [-22.9, -9]Regression, Logistic
Comparison: Week 2095% CI: [0.9, 14.8]Regression, Logistic
Comparison: Week 2495% CI: [-27.3, -13.1]Regression, Logistic
Comparison: Week 2895% CI: [-10.4, 2.4]Regression, Logistic
Comparison: Week 3295% CI: [-16.7, -2.5]Regression, Logistic
Comparison: Week 3695% CI: [-15.8, -3.4]Regression, Logistic
Comparison: Week 4095% CI: [-23.4, -9.6]Regression, Logistic
Comparison: Week 4495% CI: [-3.3, 10.4]Regression, Logistic
Comparison: Week 4895% CI: [-24.9, -11.8]Regression, Logistic
Comparison: Week 5295% CI: [-9.2, 3.2]Regression, Logistic
Comparison: Week 5695% CI: [-16.3, -2.8]Regression, Logistic
Comparison: Week 6095% CI: [-12.5, 1.1]Regression, Logistic
Comparison: Week 6495% CI: [-21.9, -8.5]Regression, Logistic
Comparison: Week 6895% CI: [-5.9, 7.5]Regression, Logistic
Comparison: Week 7295% CI: [-21.4, -8.1]Regression, Logistic
Comparison: Week 7695% CI: [-7.5, 5.4]Regression, Logistic
Comparison: Week 8095% CI: [-17.2, -3.4]Regression, Logistic
Comparison: Week 8495% CI: [-11.4, 2.3]Regression, Logistic
Comparison: Week 8895% CI: [-18.2, -4.1]Regression, Logistic
Comparison: Week 9295% CI: [-9.4, 3.5]Regression, Logistic
Comparison: Week 9695% CI: [-21.3, -7.2]Regression, Logistic
Secondary
Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye
Subretinal fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal fluid is an indicator of underlying disease. One eye (study eye) contributed to the analysis.
Time frame: 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
Population: FAS - LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 28 | 15.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 8 | 14.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 12 | 13.5 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 16 | 21.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 20 | 25.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 24 | 17.3 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 4 | 29.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 32 | 24.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 36 | 13.5 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 40 | 18.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 44 | 23.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 48 | 17.6 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 52 | 19.7 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 56 | 24.3 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 60 | 20.0 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 64 | 20.3 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 68 | 23.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 72 | 17.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 76 | 21.6 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 80 | 22.7 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 84 | 18.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 88 | 19.7 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 92 | 17.3 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 96 | 15.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 92 | 22.8 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 4 | 36.9 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 52 | 22.8 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 8 | 22.8 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 76 | 23.0 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 12 | 20.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 56 | 33.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 16 | 35.5 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 88 | 31.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 20 | 22.5 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 60 | 24.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 24 | 36.9 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 80 | 33.9 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 28 | 22.0 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 64 | 35.5 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 32 | 34.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 96 | 30.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 36 | 21.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 68 | 23.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 40 | 33.9 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 84 | 24.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 44 | 21.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 72 | 34.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye | Week 48 | 33.9 percentage of subjects |
Comparison: Week 495% CI: [-13.2, -0.3]Regression, Logistic
Comparison: Week 895% CI: [-13.8, -3]Regression, Logistic
Comparison: Week 1295% CI: [-12.2, -1.7]Regression, Logistic
Comparison: Week 1695% CI: [-20.8, -8.3]Regression, Logistic
Comparison: Week 2095% CI: [-2.9, 9.6]Regression, Logistic
Comparison: Week 2495% CI: [-25.5, -13]Regression, Logistic
Comparison: Week 2895% CI: [-11.6, -0.4]Regression, Logistic
Comparison: Week 3295% CI: [-16.5, -3.5]Regression, Logistic
Comparison: Week 3695% CI: [-13.6, -2.5]Regression, Logistic
Comparison: Week 4095% CI: [-21.5, -9.4]Regression, Logistic
Comparison: Week 4495% CI: [-3.2, 8.4]Regression, Logistic
Comparison: Week 4895% CI: [-22.4, -10.4]Regression, Logistic
Comparison: Week 5295% CI: [-8.5, 3.1]Regression, Logistic
Comparison: Week 5695% CI: [-15.7, -2.9]Regression, Logistic
Comparison: Week 6095% CI: [-9.8, 2.2]Regression, Logistic
Comparison: Week 6495% CI: [-21.3, -8.4]Regression, Logistic
Comparison: Week 6895% CI: [-6.1, 6.2]Regression, Logistic
Comparison: Week 7295% CI: [-22.6, -10.5]Regression, Logistic
Comparison: Week 7695% CI: [-7, 5.1]Regression, Logistic
Comparison: Week 8095% CI: [-17.4, -5]Regression, Logistic
Comparison: Week 8495% CI: [-11.3, 0.7]Regression, Logistic
Comparison: Week 8895% CI: [-18.9, -5.9]Regression, Logistic
Comparison: Week 9295% CI: [-11.4, 0]Regression, Logistic
Comparison: Week 9695% CI: [-20.3, -8.3]Regression, Logistic
Secondary
Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye
Sub-retinal pigment epithelium (RPE) fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of sub-RPE fluid is an indicator of underlying disease. One eye (study eye) contributed to the analysis.
Time frame: 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
Population: FAS - LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 8 | 16.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 36 | 13.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 64 | 19.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 40 | 15.4 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 12 | 15.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 44 | 14.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 60 | 15.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 48 | 13.0 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 16 | 15.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 52 | 17.3 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 68 | 18.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 72 | 17.0 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 20 | 17.3 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 76 | 16.5 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 88 | 21.9 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 80 | 21.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 24 | 10.5 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 84 | 23.2 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 4 | 18.1 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 28 | 13.8 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 92 | 17.3 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 56 | 19.7 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 96 | 16.5 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 32 | 18.1 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 44 | 14.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 56 | 24.9 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 60 | 21.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 64 | 24.1 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 4 | 21.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 8 | 18.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 12 | 17.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 16 | 23.8 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 20 | 16.0 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 24 | 18.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 28 | 15.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 32 | 23.3 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 36 | 18.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 40 | 21.4 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 52 | 19.0 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 48 | 22.0 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 68 | 23.3 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 72 | 23.8 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 76 | 22.0 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 80 | 27.6 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 84 | 24.7 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 88 | 26.8 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 92 | 23.0 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye | Week 96 | 22.5 percentage of subjects |
Comparison: Week 495% CI: [-8.9, 1.5]Regression, Logistic
Comparison: Week 895% CI: [-7.6, 2.5]Regression, Logistic
Comparison: Week 1295% CI: [-6.9, 3.7]Regression, Logistic
Comparison: Week 1695% CI: [-13, -2.7]Regression, Logistic
Comparison: Week 2095% CI: [-3.6, 6.2]Regression, Logistic
Comparison: Week 2495% CI: [-12.6, -3.1]Regression, Logistic
Comparison: Week 2895% CI: [-6.8, 2.7]Regression, Logistic
Comparison: Week 3295% CI: [-10.5, -0.3]Regression, Logistic
Comparison: Week 3695% CI: [-10.3, -0.4]Regression, Logistic
Comparison: Week 4095% CI: [-11.2, -0.5]Regression, Logistic
Comparison: Week 4495% CI: [-4.8, 5.6]Regression, Logistic
Comparison: Week 4895% CI: [-13.8, -3.9]Regression, Logistic
Comparison: Week 5295% CI: [-7.1, 3.5]Regression, Logistic
Comparison: Week 5695% CI: [-11.1, 0.1]Regression, Logistic
Comparison: Week 6095% CI: [-10.9, -0.5]Regression, Logistic
Comparison: Week 6495% CI: [-10.9, 0.6]Regression, Logistic
Comparison: Week 6895% CI: [-11, -0.1]Regression, Logistic
Comparison: Week 7295% CI: [-12.5, -1.2]Regression, Logistic
Comparison: Week 7695% CI: [-10.7, -0.3]Regression, Logistic
Comparison: Week 8095% CI: [-12.4, -0.9]Regression, Logistic
Comparison: Week 8495% CI: [-7, 4.4]Regression, Logistic
Comparison: Week 8895% CI: [-10.5, 1.3]Regression, Logistic
Comparison: Week 9295% CI: [-11.4, 0.5]Regression, Logistic
Comparison: Week 9695% CI: [-11.5, -0.3]Regression, Logistic
Secondary
Percentage of Subjects With Subretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye
Subretinal hemorrhage was assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal hemorrhage is an indicator of underlying disease. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
Time frame: Baseline, Weeks 12, 48, 96
Population: FAS with non-missing values. Number Analyzed represents the number of subjects with a value for both baseline and the specific post-baseline visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6 mg | Percentage of Subjects With Subretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye | Week 12 | 0.6 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Subretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye | Week 48 | 0.6 percentage of subjects |
| Brolucizumab 6 mg | Percentage of Subjects With Subretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye | Week 96 | 0.0 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Subretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye | Week 12 | 1.2 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Subretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye | Week 48 | 0.3 percentage of subjects |
| Aflibercept 2 mg | Percentage of Subjects With Subretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye | Week 96 | 0.0 percentage of subjects |
Secondary
Proportion of Subjects With Positive q12 (Every 12 Weeks) Treatment Status at Week 48
Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks q12w, after the initial three loading injections every 4 weeks q4w). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44) to identify q8w (one injection every 8 weeks) need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified.
Time frame: Weeks 16, 20, 28, 32, 40, 44, 48
Population: FAS - efficacy/safety approach
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brolucizumab 6 mg | Proportion of Subjects With Positive q12 (Every 12 Weeks) Treatment Status at Week 48 | 0.5101 proportion of subjects |
Secondary
Proportion of Subjects With Positive q12 Treatment Status at Week 48 Within the Subjects With no q8 (Every 8 Weeks) Treatment Need During the Initial q12w Cycle (Week 16, Week 20)
Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks q12w, after the initial three loading injections every 4 weeks q4w). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified.
Time frame: Weeks 16, 20, 28, 32, 40, 44, 48
Population: FAS - efficacy/safety approach
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brolucizumab 6 mg | Proportion of Subjects With Positive q12 Treatment Status at Week 48 Within the Subjects With no q8 (Every 8 Weeks) Treatment Need During the Initial q12w Cycle (Week 16, Week 20) | 0.8170 proportion of subjects |
Secondary
Proportion of Subjects With Positive q12 Treatment Status at Week 96 Within the Subjects With no q8 Treatment Need During the Initial q12w Cycle (Week 16, Week 20)
Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks q12w, after the initial three loading injections every 4 weeks q4w). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified.
Time frame: Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92, 96
Population: FAS - efficacy/safety approach
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brolucizumab 6 mg | Proportion of Subjects With Positive q12 Treatment Status at Week 96 Within the Subjects With no q8 Treatment Need During the Initial q12w Cycle (Week 16, Week 20) | 0.6170 proportion of subjects |
Secondary
Proportion of Subjects With Positive q12 Treatment Status up to Week 96
Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks q12w, after the initial three loading injections every 4 weeks q4w). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified.
Time frame: Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92, 96
Population: FAS - efficacy/safety approach
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brolucizumab 6 mg | Proportion of Subjects With Positive q12 Treatment Status up to Week 96 | 0.3856 proportion of subjects |