Branch Retinal Vein Occlusion
Conditions
Keywords
Visual impairment, Macular edema, Branch retinal vein occlusion, BRVO, Brolucizumab, Aflibercept, Vascular endothelial growth factor, VEGF, anti-VEGF
Brief summary
The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with macular edema (ME) secondary to branch retinal vein occlusion (BRVO).
Detailed description
The study was comprised of a Screening period (Day -28 to Day -1), Double-masked treatment period (Day 1 to Week 72) and Post-treatment follow-up period (Week 72 to Week 76). Treatment visits were scheduled in 4-week intervals. After 6 initial monthly injections of brolucizumab or aflibercept (loading phase), subjects entered a one-year individualized flexible treatment (IFT) phase. During the IFT phase, an assessment of disease stability was performed at each monthly visit and subjects received either an active or a sham injection. Treatment with active was interrupted when disease stability was reached.
Interventions
Solution for injection (intravitreal use)
DRUGAflibercept 2 mg
Solution for injection (Intravitreal use)
OTHERSham injection
Empty sterile syringe without a needle administered as a sham injection for masking purposes. From Week 24 to Week 72 inclusive, a sham treatment was performed to maintain subject masking in case treatment with brolucizumab or aflibercept was not deemed necessary by the investigator.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
A masked evaluating investigator was responsible for all aspects of the study except the injections and the safety assessment following the injections. An unmasked treating investigator performed the injections and assessed patient safety following the injections.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent must be obtained prior to participation in the study. * Patients with visual impairment due to ME secondary to BRVO diagnosed \< 6 months prior to screening. * BCVA score between 78 and 23 letters, inclusive, using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/32 to 20/320) at both screening and baseline visits.
Exclusion criteria
* Concomitant conditions or ocular disorders in the study eye at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the first 12-month study period (e.g. structural damage of the fovea, vitreous hemorrhage, retinal vascular occlusion other than BRVO, retinal detachment, macular hole, or choroidal neovascularization of any cause, diabetic retinopathy (except mild non-proliferative) and diabetic macular edema). Hemiretinal vein occlusion should be excluded. * Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in study eye at screening or baseline * Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) \> 25 mmHg on medication, or according to investigator's judgment, at screening or baseline * Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA \< 20/200 at screening (except when due to conditions whose surgery may improve VA, e.g. cataract) * Previous treatment with any anti-VEGF therapy or investigational drugs in the study eye at any time prior to baseline * Previous use of intraocular or periocular steroids in study eye at any time prior to baseline * Macular laser photocoagulation (focal/grid) in the study eye at any time prior to baseline and peripheral laser photocoagulation in the study eye within 3 months prior to the baseline * Intraocular surgery in the study eye during the 3-month period prior to baseline * Vitreoretinal surgery in the study eye at any time prior to baseline * Aphakia with the absence of posterior capsule in the study eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 24 | Baseline, Week 24 | BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning. Missing and censored BCVA values were imputed by Last observation carried forward (LOCF) as the primary approach. Observed values from both scheduled and unscheduled post-baseline visits were used for the LOCF imputation. For subjects with no post-baseline BCVA value, the baseline value was carried forward. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in BCVA Averaged Over Week 64 to Week 76 | Baseline, Week 64 to Week 76 | An average BCVA over week 64 to week 76 was calculated. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning. |
| Change From Baseline in BCVA by Visit up to Week 76 | Baseline and every 4 weeks from baseline up to Week 76 | BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning. |
| Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Baseline and every 4 weeks from baseline up to Week 76 | The summary by visit was conducted based on the BCVA observed from each of the corresponding visits. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning. Every 5 letters represents 1 line of vision on the reading chart. |
| Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Baseline and every 4 weeks from baseline up to Week 76 | The summary by visit was conducted based on the BCVA observed from each of the corresponding visit. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning. Every 5 letters represents 1 line of vision on the reading chart. |
| Change From Baseline in CSFT Averaged Over Week 40 to Week 52 | Baseline, Week 40 to Week 52 | Change from baseline in central subfield thickness (CSFT) averaged over Week 40 to Week 52 , measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT) |
| Change From Baseline in CSFT Averaged Over Week 64 to Week 76 | Baseline, Week 64 to Week 76 | Change from baseline in central subfield thickness (CSFT) averaged over Week 64 to Week 76, measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT) |
| Change From Baseline in CSFT by Visit up to Week 76 | Baseline, and every 4 weeks from baseline up to Week 76 | Change from baseline in central subfield thickness (CSFT) measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT) |
| Change From Baseline in BCVA Averaged Over Week 40 to Week 52 | Baseline, Week 40 to Week 52 | An average BCVA over week 40 to week 52 was calculated. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning. |
| Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Every 4 weeks from Week 4 up to Week 76 | Central subfield thickness (CSFT) is measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT) |
| Number of Injections Between Week 24 and Week 52 and Between Week 24 and Week 72 | Week 24 to Week 52 and Week 24 to Week 72 | Number of administered injections during the individualized flexible treatment (IFT) period, between Week 24 and Week 52 and between Week 24 and Week 72 are presented |
| Time to Recurrence After Week 20 and up to Week 76 | Week 20 to Week 76 | Recurrence is defined as the need for injection while showing a lack of disease stability for the first time after Week 20 and up to Week 76. For subjects with recurrence after the Week 20 visit, time-to-event is calculated as (first time with the lack of disease stability - the injection date on Week 20 visit + 1). For subjects without recurrence after Week 20, the censoring time will be calculated as (last visit with disease stability assessment - the injection date on Week 20 visit + 1). |
| Number of Subjects With Ocular and Non-ocular AEs up to Week 52 and Week 76 | Baseline to Week 76 | Number of subjects with at least one ocular or non-ocular Adverse Events (AEs). |
| Change From Baseline in Patient Reported Outcomes (NEI VFQ-25) at Week 24, Week 52 and Week 76 | Baseline, Week 24, Week 52 and Week 76 | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures a patient's subjective assessment of vision-related Quality of Life (QoL). The 11 subscales in the VFQ-25 are general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated better vision-related quality of life. |
| Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Baseline, Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Anti-drug antibodies (ADA) levels were assessed from subjects assigned to brolucizumab treatment only. |
| Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Every 4 weeks from baseline up to Week 76 | Presence of retinal fluid (intra- and/or subretinal fluid) assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) |
Countries
Austria, Canada, China, Czechia, Denmark, France, Germany, Hong Kong, Israel, Italy, Japan, Puerto Rico, Russia, Slovakia, Spain, Switzerland, Taiwan, United Kingdom, United States
Participant flow
Recruitment details
Participants were recruited from 103 sites in 18 countries
Pre-assignment details
The study comprised a screening period of 28 days
Participants by arm
| Arm | Count |
|---|---|
| Brolucizumab 6 mg 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) | 226 |
| Aflibercept 2 mg 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) | 224 |
| Total | 450 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 1 |
| Overall Study | Death | 0 | 2 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Study terminated by sponsor | 130 | 134 |
| Overall Study | Subject decision | 16 | 9 |
Baseline characteristics
| Characteristic | Brolucizumab 6 mg | Aflibercept 2 mg | Total |
|---|---|---|---|
| Age, Continuous | 65.4 Years STANDARD_DEVIATION 11.05 | 65.0 Years STANDARD_DEVIATION 10.92 | 65.2 Years STANDARD_DEVIATION 10.97 |
| Race/Ethnicity, Customized Asian | 65 Participants | 67 Participants | 132 Participants |
| Race/Ethnicity, Customized Black or African American | 8 Participants | 4 Participants | 12 Participants |
| Race/Ethnicity, Customized White | 154 Participants | 153 Participants | 307 Participants |
| Sex: Female, Male Female | 117 Participants | 125 Participants | 242 Participants |
| Sex: Female, Male Male | 109 Participants | 99 Participants | 208 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 226 | 2 / 224 | 2 / 450 |
| other Total, other adverse events | 109 / 226 | 95 / 224 | 204 / 450 |
| serious Total, serious adverse events | 32 / 226 | 16 / 224 | 48 / 450 |
Outcome results
Primary
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 24
BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning. Missing and censored BCVA values were imputed by Last observation carried forward (LOCF) as the primary approach. Observed values from both scheduled and unscheduled post-baseline visits were used for the LOCF imputation. For subjects with no post-baseline BCVA value, the baseline value was carried forward.
Time frame: Baseline, Week 24
Population: Full Analysis Set (FAS) included all randomized subjects who received at least one Intravitreal injection of the study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 24 | 13.1 Letters read | Standard Error 0.71 |
| Aflibercept 2 mg | Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 24 | 15.0 Letters read | Standard Error 0.71 |
p-value: 0.01895% CI: [-3.9, 0.1]ANOVA
Secondary
Change From Baseline in BCVA Averaged Over Week 40 to Week 52
An average BCVA over week 40 to week 52 was calculated. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.
Time frame: Baseline, Week 40 to Week 52
Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment.~The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline in BCVA Averaged Over Week 40 to Week 52 | 12.9 Letters read | Standard Deviation 12.81 |
| Aflibercept 2 mg | Change From Baseline in BCVA Averaged Over Week 40 to Week 52 | 16.9 Letters read | Standard Deviation 10.63 |
Secondary
Change From Baseline in BCVA Averaged Over Week 64 to Week 76
An average BCVA over week 64 to week 76 was calculated. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.
Time frame: Baseline, Week 64 to Week 76
Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment.~The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline in BCVA Averaged Over Week 64 to Week 76 | 13.7 Letters read | Standard Deviation 13.33 |
| Aflibercept 2 mg | Change From Baseline in BCVA Averaged Over Week 64 to Week 76 | 17.9 Letters read | Standard Deviation 10.65 |
Secondary
Change From Baseline in BCVA by Visit up to Week 76
BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.
Time frame: Baseline and every 4 weeks from baseline up to Week 76
Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment.~The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 36 | 11.8 Letters read | Standard Deviation 14.75 |
| Brolucizumab 6 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 16 | 12.2 Letters read | Standard Deviation 12.59 |
| Brolucizumab 6 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 40 | 12.7 Letters read | Standard Deviation 12.89 |
| Brolucizumab 6 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 56 | 14.9 Letters read | Standard Deviation 10.86 |
| Brolucizumab 6 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 44 | 13.5 Letters read | Standard Deviation 13.28 |
| Brolucizumab 6 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 20 | 13.5 Letters read | Standard Deviation 10.83 |
| Brolucizumab 6 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 48 | 13.3 Letters read | Standard Deviation 13.38 |
| Brolucizumab 6 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 8 | 11.9 Letters read | Standard Deviation 10.68 |
| Brolucizumab 6 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 52 | 13.5 Letters read | Standard Deviation 13.42 |
| Brolucizumab 6 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 24 | 12.7 Letters read | Standard Deviation 12.36 |
| Brolucizumab 6 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 60 | 13.7 Letters read | Standard Deviation 13.67 |
| Brolucizumab 6 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 72 | 13.9 Letters read | Standard Deviation 13.38 |
| Brolucizumab 6 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 64 | 14.1 Letters read | Standard Deviation 13.72 |
| Brolucizumab 6 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 28 | 12.1 Letters read | Standard Deviation 13.88 |
| Brolucizumab 6 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 68 | 13.9 Letters read | Standard Deviation 13.83 |
| Brolucizumab 6 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 12 | 13.2 Letters read | Standard Deviation 10.22 |
| Brolucizumab 6 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 32 | 12.2 Letters read | Standard Deviation 13.24 |
| Brolucizumab 6 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 76 | 14.4 Letters read | Standard Deviation 13.72 |
| Brolucizumab 6 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 4 | 9.2 Letters read | Standard Deviation 8.22 |
| Aflibercept 2 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 76 | 18.1 Letters read | Standard Deviation 11.19 |
| Aflibercept 2 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 4 | 10.3 Letters read | Standard Deviation 10.13 |
| Aflibercept 2 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 8 | 12.8 Letters read | Standard Deviation 10.84 |
| Aflibercept 2 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 12 | 14.8 Letters read | Standard Deviation 11.23 |
| Aflibercept 2 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 16 | 16.3 Letters read | Standard Deviation 11.58 |
| Aflibercept 2 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 20 | 16.3 Letters read | Standard Deviation 12.15 |
| Aflibercept 2 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 24 | 16.6 Letters read | Standard Deviation 11.35 |
| Aflibercept 2 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 28 | 16.4 Letters read | Standard Deviation 10.62 |
| Aflibercept 2 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 32 | 15.7 Letters read | Standard Deviation 10.94 |
| Aflibercept 2 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 36 | 16.9 Letters read | Standard Deviation 10.95 |
| Aflibercept 2 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 40 | 16.9 Letters read | Standard Deviation 10.74 |
| Aflibercept 2 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 44 | 17.2 Letters read | Standard Deviation 11.37 |
| Aflibercept 2 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 48 | 17.7 Letters read | Standard Deviation 10.79 |
| Aflibercept 2 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 56 | 17.7 Letters read | Standard Deviation 10.62 |
| Aflibercept 2 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 60 | 17.7 Letters read | Standard Deviation 10.33 |
| Aflibercept 2 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 64 | 18.0 Letters read | Standard Deviation 10.54 |
| Aflibercept 2 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 68 | 17.7 Letters read | Standard Deviation 10.75 |
| Aflibercept 2 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 72 | 18.4 Letters read | Standard Deviation 11.44 |
| Aflibercept 2 mg | Change From Baseline in BCVA by Visit up to Week 76 | Week 52 | 17.2 Letters read | Standard Deviation 10.46 |
Secondary
Change From Baseline in CSFT Averaged Over Week 40 to Week 52
Change from baseline in central subfield thickness (CSFT) averaged over Week 40 to Week 52 , measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT)
Time frame: Baseline, Week 40 to Week 52
Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had at least one CSFT assessment on scheduled visits over the corresponding time point
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline in CSFT Averaged Over Week 40 to Week 52 | -231.8 µm | Standard Deviation 188.97 |
| Aflibercept 2 mg | Change From Baseline in CSFT Averaged Over Week 40 to Week 52 | -259.2 µm | Standard Deviation 190.69 |
Secondary
Change From Baseline in CSFT Averaged Over Week 64 to Week 76
Change from baseline in central subfield thickness (CSFT) averaged over Week 64 to Week 76, measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT)
Time frame: Baseline, Week 64 to Week 76
Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had at least one CSFT assessment on scheduled visits over the corresponding time point
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline in CSFT Averaged Over Week 64 to Week 76 | -243.6 µm | Standard Deviation 201.61 |
| Aflibercept 2 mg | Change From Baseline in CSFT Averaged Over Week 64 to Week 76 | -272.6 µm | Standard Deviation 194.29 |
Secondary
Change From Baseline in CSFT by Visit up to Week 76
Change from baseline in central subfield thickness (CSFT) measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT)
Time frame: Baseline, and every 4 weeks from baseline up to Week 76
Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had CSFT data available on baseline and the specific post-baseline visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 48 | -237.1 µm | Standard Deviation 200.64 |
| Brolucizumab 6 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 52 | -243.0 µm | Standard Deviation 203.87 |
| Brolucizumab 6 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 56 | -249.2 µm | Standard Deviation 206.54 |
| Brolucizumab 6 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 60 | -238.3 µm | Standard Deviation 185.78 |
| Brolucizumab 6 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 64 | -249.8 µm | Standard Deviation 207.86 |
| Brolucizumab 6 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 68 | -247.5 µm | Standard Deviation 217.61 |
| Brolucizumab 6 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 72 | -253.4 µm | Standard Deviation 211.06 |
| Brolucizumab 6 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 76 | -255.6 µm | Standard Deviation 184.22 |
| Brolucizumab 6 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 4 | -247.1 µm | Standard Deviation 197.99 |
| Brolucizumab 6 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 8 | -255.9 µm | Standard Deviation 206 |
| Brolucizumab 6 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 12 | -264.5 µm | Standard Deviation 208.7 |
| Brolucizumab 6 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 16 | -271.1 µm | Standard Deviation 209.38 |
| Brolucizumab 6 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 20 | -257.1 µm | Standard Deviation 197.31 |
| Brolucizumab 6 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 24 | -254.9 µm | Standard Deviation 203.29 |
| Brolucizumab 6 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 28 | -245.4 µm | Standard Deviation 197.62 |
| Brolucizumab 6 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 32 | -231.1 µm | Standard Deviation 208.02 |
| Brolucizumab 6 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 36 | -234.1 µm | Standard Deviation 199.02 |
| Brolucizumab 6 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 40 | -224.7 µm | Standard Deviation 190.5 |
| Brolucizumab 6 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 44 | -242.8 µm | Standard Deviation 197.34 |
| Aflibercept 2 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 40 | -259.0 µm | Standard Deviation 189.01 |
| Aflibercept 2 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 12 | -271.9 µm | Standard Deviation 194.99 |
| Aflibercept 2 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 52 | -263.4 µm | Standard Deviation 190.36 |
| Aflibercept 2 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 32 | -262.1 µm | Standard Deviation 193.8 |
| Aflibercept 2 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 56 | -271.4 µm | Standard Deviation 198.09 |
| Aflibercept 2 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 16 | -276.1 µm | Standard Deviation 209.7 |
| Aflibercept 2 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 60 | -265.3 µm | Standard Deviation 187.29 |
| Aflibercept 2 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 48 | -279.4 µm | Standard Deviation 193.41 |
| Aflibercept 2 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 64 | -266.1 µm | Standard Deviation 199.79 |
| Aflibercept 2 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 20 | -285.2 µm | Standard Deviation 210.32 |
| Aflibercept 2 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 68 | -261.1 µm | Standard Deviation 192.3 |
| Aflibercept 2 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 36 | -260.8 µm | Standard Deviation 195.03 |
| Aflibercept 2 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 72 | -279.4 µm | Standard Deviation 185.21 |
| Aflibercept 2 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 24 | -286.6 µm | Standard Deviation 207.67 |
| Aflibercept 2 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 76 | -283.7 µm | Standard Deviation 197.29 |
| Aflibercept 2 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 44 | -264.1 µm | Standard Deviation 192.06 |
| Aflibercept 2 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 4 | -259.4 µm | Standard Deviation 185.11 |
| Aflibercept 2 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 28 | -263.6 µm | Standard Deviation 197.11 |
| Aflibercept 2 mg | Change From Baseline in CSFT by Visit up to Week 76 | Week 8 | -270.7 µm | Standard Deviation 195.49 |
Secondary
Change From Baseline in Patient Reported Outcomes (NEI VFQ-25) at Week 24, Week 52 and Week 76
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures a patient's subjective assessment of vision-related Quality of Life (QoL). The 11 subscales in the VFQ-25 are general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated better vision-related quality of life.
Time frame: Baseline, Week 24, Week 52 and Week 76
Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had NEI VFQ-25 assessment on scheduled visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes (NEI VFQ-25) at Week 24, Week 52 and Week 76 | Week 76 | 8.6 score on a scale | Standard Deviation 13.89 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes (NEI VFQ-25) at Week 24, Week 52 and Week 76 | Week 24 | 5.6 score on a scale | Standard Deviation 11.51 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes (NEI VFQ-25) at Week 24, Week 52 and Week 76 | Week 52 | 6.9 score on a scale | Standard Deviation 13.21 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes (NEI VFQ-25) at Week 24, Week 52 and Week 76 | Week 52 | 7.6 score on a scale | Standard Deviation 10.47 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes (NEI VFQ-25) at Week 24, Week 52 and Week 76 | Week 76 | 7.5 score on a scale | Standard Deviation 11.55 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes (NEI VFQ-25) at Week 24, Week 52 and Week 76 | Week 24 | 6.4 score on a scale | Standard Deviation 11.92 |
Secondary
Number of Injections Between Week 24 and Week 52 and Between Week 24 and Week 72
Number of administered injections during the individualized flexible treatment (IFT) period, between Week 24 and Week 52 and between Week 24 and Week 72 are presented
Time frame: Week 24 to Week 52 and Week 24 to Week 72
Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who were on study treatment until week 52 and until week 72.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Number of Injections Between Week 24 and Week 52 and Between Week 24 and Week 72 | Between Week 24 and Week 52 | 2.2 Injections | Standard Deviation 1.69 |
| Brolucizumab 6 mg | Number of Injections Between Week 24 and Week 52 and Between Week 24 and Week 72 | Between Week 24 and Week 72 | 3.2 Injections | Standard Deviation 2.54 |
| Aflibercept 2 mg | Number of Injections Between Week 24 and Week 52 and Between Week 24 and Week 72 | Between Week 24 and Week 52 | 2.5 Injections | Standard Deviation 2.17 |
| Aflibercept 2 mg | Number of Injections Between Week 24 and Week 52 and Between Week 24 and Week 72 | Between Week 24 and Week 72 | 4.0 Injections | Standard Deviation 3.28 |
Secondary
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76
Anti-drug antibodies (ADA) levels were assessed from subjects assigned to brolucizumab treatment only.
Time frame: Baseline, Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76
Population: SAF-observed: Safety Analysis Set (SAF) included all subjects who received at least one intravitreal injection with brolucizumab. The number analyzed is the number of subjects from the SAF who had a value for ADA status on scheduled visits.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Baseline | 120 | 33 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Baseline | 360 | 37 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Baseline | 1080 | 31 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Baseline | 3240 | 15 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Baseline | Negative | 67 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Baseline | 40 | 29 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Baseline | 9720 | 1 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Baseline | 29200 | 6 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 4 | Negative | 76 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 4 | 40 | 29 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 4 | 120 | 31 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 4 | 360 | 28 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 4 | 1080 | 27 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 4 | 3240 | 9 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 4 | 9720 | 6 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 4 | 29200 | 2 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 12 | Negative | 58 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 12 | 40 | 17 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 12 | 120 | 31 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 12 | 360 | 25 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 12 | 1080 | 19 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 12 | 3240 | 11 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 12 | 9720 | 7 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 12 | 29200 | 2 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 24 | Negative | 44 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 24 | 40 | 14 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 24 | 120 | 23 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 24 | 360 | 17 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 24 | 1080 | 19 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 24 | 3240 | 11 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 24 | 9720 | 5 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 24 | 29200 | 1 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 36 | Negative | 33 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 36 | 40 | 18 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 36 | 120 | 19 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 36 | 360 | 17 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 36 | 1080 | 17 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 36 | 3240 | 8 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 36 | 9720 | 1 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 36 | 29200 | 1 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 52 | Negative | 28 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 52 | 40 | 18 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 52 | 120 | 19 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 52 | 360 | 16 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 52 | 1080 | 14 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 52 | 3240 | 5 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 52 | 9720 | 1 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 52 | 29200 | 0 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 76 | Negative | 17 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 76 | 40 | 6 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 76 | 120 | 18 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 76 | 360 | 14 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 76 | 1080 | 10 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 76 | 3240 | 2 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 76 | 9720 | 1 Participants |
| Brolucizumab 6 mg | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 | Week 76 | 29200 | 0 Participants |
Secondary
Number of Subjects With Ocular and Non-ocular AEs up to Week 52 and Week 76
Number of subjects with at least one ocular or non-ocular Adverse Events (AEs).
Time frame: Baseline to Week 76
Population: Safety Analysis Set (SAF) included all subjects who received at least one intravitreal injection.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6 mg | Number of Subjects With Ocular and Non-ocular AEs up to Week 52 and Week 76 | Ocular AEs up to week 52 | 93 Participants |
| Brolucizumab 6 mg | Number of Subjects With Ocular and Non-ocular AEs up to Week 52 and Week 76 | Non-Ocular AEs up to week 52 | 94 Participants |
| Brolucizumab 6 mg | Number of Subjects With Ocular and Non-ocular AEs up to Week 52 and Week 76 | Ocular AEs up to week 76 | 98 Participants |
| Brolucizumab 6 mg | Number of Subjects With Ocular and Non-ocular AEs up to Week 52 and Week 76 | Non-Ocular AEs up to week 76 | 103 Participants |
| Aflibercept 2 mg | Number of Subjects With Ocular and Non-ocular AEs up to Week 52 and Week 76 | Non-Ocular AEs up to week 76 | 120 Participants |
| Aflibercept 2 mg | Number of Subjects With Ocular and Non-ocular AEs up to Week 52 and Week 76 | Ocular AEs up to week 52 | 72 Participants |
| Aflibercept 2 mg | Number of Subjects With Ocular and Non-ocular AEs up to Week 52 and Week 76 | Ocular AEs up to week 76 | 75 Participants |
| Aflibercept 2 mg | Number of Subjects With Ocular and Non-ocular AEs up to Week 52 and Week 76 | Non-Ocular AEs up to week 52 | 112 Participants |
Secondary
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline
The summary by visit was conducted based on the BCVA observed from each of the corresponding visits. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning. Every 5 letters represents 1 line of vision on the reading chart.
Time frame: Baseline and every 4 weeks from baseline up to Week 76
Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 20; BCVA gain from baseline >=15 | 74 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 40; BCVA gain from baseline >=15 | 65 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 12; BCVA gain from baseline >=10 | 114 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 44; BCVA gain from baseline >=5 | 94 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 24; BCVA gain from baseline >=5 | 122 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 44; BCVA gain from baseline >=10 | 78 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 4; BCVA gain from baseline >=5 | 154 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 44; BCVA gain from baseline >=15 | 64 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 24; BCVA gain from baseline >=10 | 90 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 48; BCVA gain from baseline >=5 | 92 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 12; BCVA gain from baseline >=15 | 90 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 48; BCVA gain from baseline >=10 | 76 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 24; BCVA gain from baseline >=15 | 75 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 48; BCVA gain from baseline >=15 | 61 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 8; BCVA gain from baseline >=10 | 117 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 52; BCVA gain from baseline >=5 | 87 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 28; BCVA gain from baseline >=5 | 108 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 52; BCVA gain from baseline >=10 | 75 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 16; BCVA gain from baseline >=5 | 127 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 52; BCVA gain from baseline >=15 | 64 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 28; BCVA gain from baseline >=10 | 89 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 56; BCVA gain from baseline >=5 | 90 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 4; BCVA gain from baseline >=15 | 64 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 56; BCVA gain from baseline >=10 | 76 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 16; BCVA gain from baseline >=10 | 95 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 56; BCVA gain from baseline >=15 | 58 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 32; BCVA gain from baseline >=5 | 97 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 60; BCVA gain from baseline >=5 | 86 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 8; BCVA gain from baseline >=15 | 92 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 60; BCVA gain from baseline >=10 | 71 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 32; BCVA gain from baseline >=10 | 79 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 60; BCVA gain from baseline >=15 | 62 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 16; BCVA gain from baseline >=15 | 73 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 64; BCVA gain from baseline >=5 | 86 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 32; BCVA gain from baseline >=15 | 60 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 64; BCVA gain from baseline >=10 | 74 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 4; BCVA gain from baseline >=10 | 102 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 64; BCVA gain from baseline >=15 | 58 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 36; BCVA gain from baseline >=5 | 100 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 68; BCVA gain from baseline >=5 | 79 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 20; BCVA gain from baseline >=5 | 119 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 68; BCVA gain from baseline >=10 | 67 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 36; BCVA gain from baseline >=10 | 81 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 68; BCVA gain from baseline >=15 | 55 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 12; BCVA gain from baseline >=5 | 156 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 72; BCVA gain from baseline >=5 | 68 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 36; BCVA gain from baseline >=15 | 62 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 72; BCVA gain from baseline >=10 | 56 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 20; BCVA gain from baseline >=10 | 96 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 72; BCVA gain from baseline >=15 | 45 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 40; BCVA gain from baseline >=5 | 96 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 76; BCVA gain from baseline >=5 | 62 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 8; BCVA gain from baseline >=5 | 158 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 76; BCVA gain from baseline >=10 | 52 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 40; BCVA gain from baseline >=10 | 79 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 76; BCVA gain from baseline >=15 | 43 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 28; BCVA gain from baseline >=15 | 75 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 76; BCVA gain from baseline >=15 | 53 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 4; BCVA gain from baseline >=5 | 150 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 4; BCVA gain from baseline >=10 | 110 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 4; BCVA gain from baseline >=15 | 79 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 8; BCVA gain from baseline >=5 | 155 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 8; BCVA gain from baseline >=10 | 118 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 8; BCVA gain from baseline >=15 | 93 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 12; BCVA gain from baseline >=5 | 156 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 12; BCVA gain from baseline >=10 | 125 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 12; BCVA gain from baseline >=15 | 102 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 16; BCVA gain from baseline >=5 | 143 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 16; BCVA gain from baseline >=10 | 118 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 16; BCVA gain from baseline >=15 | 100 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 20; BCVA gain from baseline >=5 | 131 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 20; BCVA gain from baseline >=10 | 108 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 20; BCVA gain from baseline >=15 | 92 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 24; BCVA gain from baseline >=5 | 126 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 24; BCVA gain from baseline >=10 | 109 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 24; BCVA gain from baseline >=15 | 91 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 28; BCVA gain from baseline >=5 | 121 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 28; BCVA gain from baseline >=10 | 107 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 28; BCVA gain from baseline >=15 | 87 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 32; BCVA gain from baseline >=5 | 110 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 32; BCVA gain from baseline >=10 | 94 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 32; BCVA gain from baseline >=15 | 78 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 36; BCVA gain from baseline >=5 | 112 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 36; BCVA gain from baseline >=10 | 98 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 36; BCVA gain from baseline >=15 | 83 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 40; BCVA gain from baseline >=5 | 114 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 40; BCVA gain from baseline >=10 | 98 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 40; BCVA gain from baseline >=15 | 85 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 44; BCVA gain from baseline >=5 | 111 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 44; BCVA gain from baseline >=10 | 97 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 44; BCVA gain from baseline >=15 | 88 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 48; BCVA gain from baseline >=5 | 112 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 48; BCVA gain from baseline >=10 | 95 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 48; BCVA gain from baseline >=15 | 80 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 52; BCVA gain from baseline >=5 | 117 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 52; BCVA gain from baseline >=10 | 99 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 52; BCVA gain from baseline >=15 | 87 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 56; BCVA gain from baseline >=5 | 113 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 56; BCVA gain from baseline >=10 | 106 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 56; BCVA gain from baseline >=15 | 84 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 60; BCVA gain from baseline >=5 | 116 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 60; BCVA gain from baseline >=10 | 104 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 60; BCVA gain from baseline >=15 | 88 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 64; BCVA gain from baseline >=5 | 112 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 64; BCVA gain from baseline >=10 | 98 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 64; BCVA gain from baseline >=15 | 82 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 68; BCVA gain from baseline >=5 | 103 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 68; BCVA gain from baseline >=10 | 88 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 68; BCVA gain from baseline >=15 | 76 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 72; BCVA gain from baseline >=5 | 89 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 72; BCVA gain from baseline >=10 | 75 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 72; BCVA gain from baseline >=15 | 63 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 76; BCVA gain from baseline >=5 | 67 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 76; BCVA gain from baseline >=10 | 61 Participants |
Secondary
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline
The summary by visit was conducted based on the BCVA observed from each of the corresponding visit. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning. Every 5 letters represents 1 line of vision on the reading chart.
Time frame: Baseline and every 4 weeks from baseline up to Week 76
Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 20; BCVA loss from baseline >=10 | 2 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 40; BCVA loss from baseline >=10 | 4 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 12; BCVA loss from baseline >=5 | 3 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 40; BCVA loss from baseline >=15 | 2 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 20; BCVA loss from baseline >=15 | 2 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 44; BCVA loss from baseline >=5 | 4 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 68; BCVA loss from baseline >=10 | 3 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 44; BCVA loss from baseline >=10 | 3 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 24; BCVA loss from baseline >=5 | 8 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 44; BCVA loss from baseline >=15 | 2 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 12; BCVA loss from baseline >=10 | 2 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 48; BCVA loss from baseline >=5 | 5 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 24; BCVA loss from baseline >=10 | 3 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 48; BCVA loss from baseline >=10 | 3 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 8; BCVA loss from baseline >=5 | 2 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 48; BCVA loss from baseline >=15 | 1 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 24; BCVA loss from baseline >=15 | 3 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 52; BCVA loss from baseline >=5 | 5 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 12; BCVA loss from baseline >=15 | 1 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 52; BCVA loss from baseline >=10 | 3 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 28; BCVA loss from baseline >=5 | 9 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 52; BCVA loss from baseline >=15 | 2 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 4; BCVA loss from baseline >=10 | 1 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 56; BCVA loss from baseline >=5 | 3 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 28; BCVA loss from baseline >=10 | 6 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 56; BCVA loss from baseline >=10 | 1 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 16; BCVA loss from baseline >=5 | 9 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 56; BCVA loss from baseline >=15 | 0 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 28; BCVA loss from baseline >=15 | 6 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 60; BCVA loss from baseline >=5 | 7 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 8; BCVA loss from baseline >=10 | 1 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 32; BCVA loss from baseline >=5 | 8 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 60; BCVA loss from baseline >=15 | 1 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 16; BCVA loss from baseline >=10 | 5 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 64; BCVA loss from baseline >=5 | 5 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 32; BCVA loss from baseline >=10 | 5 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 64; BCVA loss from baseline >=10 | 1 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 4; BCVA loss from baseline >=5 | 6 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 64; BCVA loss from baseline >=15 | 1 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 32; BCVA loss from baseline >=15 | 3 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 68; BCVA loss from baseline >=5 | 6 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 16; BCVA loss from baseline >=15 | 3 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 36; BCVA loss from baseline >=5 | 9 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 68; BCVA loss from baseline >=15 | 1 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 8; BCVA loss from baseline >=15 | 1 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 72; BCVA loss from baseline >=5 | 1 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 36; BCVA loss from baseline >=10 | 7 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 72; BCVA loss from baseline >=10 | 1 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 20; BCVA loss from baseline >=5 | 6 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 72; BCVA loss from baseline >=15 | 1 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 36; BCVA loss from baseline >=15 | 5 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 76; BCVA loss from baseline >=5 | 2 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 4; BCVA loss from baseline >=15 | 0 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 76; BCVA loss from baseline >=10 | 1 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 40; BCVA loss from baseline >=5 | 5 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 76; BCVA loss from baseline >=15 | 1 Participants |
| Brolucizumab 6 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 60; BCVA loss from baseline >=10 | 3 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 76; BCVA loss from baseline >=15 | 0 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 4; BCVA loss from baseline >=5 | 7 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 4; BCVA loss from baseline >=10 | 3 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 4; BCVA loss from baseline >=15 | 0 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 8; BCVA loss from baseline >=5 | 4 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 8; BCVA loss from baseline >=10 | 2 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 8; BCVA loss from baseline >=15 | 0 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 12; BCVA loss from baseline >=5 | 2 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 12; BCVA loss from baseline >=10 | 1 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 12; BCVA loss from baseline >=15 | 0 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 16; BCVA loss from baseline >=5 | 4 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 16; BCVA loss from baseline >=10 | 2 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 16; BCVA loss from baseline >=15 | 2 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 20; BCVA loss from baseline >=5 | 4 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 20; BCVA loss from baseline >=10 | 3 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 20; BCVA loss from baseline >=15 | 1 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 24; BCVA loss from baseline >=5 | 3 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 24; BCVA loss from baseline >=10 | 3 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 24; BCVA loss from baseline >=15 | 1 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 28; BCVA loss from baseline >=5 | 2 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 28; BCVA loss from baseline >=10 | 1 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 28; BCVA loss from baseline >=15 | 1 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 32; BCVA loss from baseline >=5 | 3 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 32; BCVA loss from baseline >=10 | 2 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 32; BCVA loss from baseline >=15 | 0 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 36; BCVA loss from baseline >=5 | 2 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 36; BCVA loss from baseline >=10 | 1 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 36; BCVA loss from baseline >=15 | 1 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 40; BCVA loss from baseline >=5 | 4 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 40; BCVA loss from baseline >=10 | 1 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 40; BCVA loss from baseline >=15 | 1 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 44; BCVA loss from baseline >=5 | 5 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 44; BCVA loss from baseline >=10 | 3 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 44; BCVA loss from baseline >=15 | 2 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 48; BCVA loss from baseline >=5 | 3 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 48; BCVA loss from baseline >=10 | 1 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 48; BCVA loss from baseline >=15 | 1 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 52; BCVA loss from baseline >=5 | 2 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 52; BCVA loss from baseline >=10 | 1 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 52; BCVA loss from baseline >=15 | 1 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 56; BCVA loss from baseline >=5 | 3 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 56; BCVA loss from baseline >=10 | 1 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 56; BCVA loss from baseline >=15 | 0 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 60; BCVA loss from baseline >=5 | 2 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 60; BCVA loss from baseline >=10 | 0 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 60; BCVA loss from baseline >=15 | 0 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 64; BCVA loss from baseline >=5 | 2 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 64; BCVA loss from baseline >=10 | 1 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 64; BCVA loss from baseline >=15 | 1 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 68; BCVA loss from baseline >=5 | 3 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 68; BCVA loss from baseline >=10 | 1 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 68; BCVA loss from baseline >=15 | 0 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 72; BCVA loss from baseline >=5 | 2 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 72; BCVA loss from baseline >=10 | 2 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 72; BCVA loss from baseline >=15 | 1 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 76; BCVA loss from baseline >=5 | 2 Participants |
| Aflibercept 2 mg | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline | Week 76; BCVA loss from baseline >=10 | 0 Participants |
Secondary
Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76
Central subfield thickness (CSFT) is measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT)
Time frame: Every 4 weeks from Week 4 up to Week 76
Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had non-missing CSFT assessment at the corresponding visit
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 4 | 167 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 44 | 95 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 24 | 127 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 48 | 89 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 12 | 156 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 52 | 86 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 28 | 109 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 56 | 86 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 16 | 137 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 60 | 83 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 32 | 92 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 64 | 85 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 8 | 172 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 68 | 82 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 36 | 96 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 72 | 70 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 20 | 120 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 76 | 59 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 40 | 94 Participants |
| Aflibercept 2 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 76 | 59 Participants |
| Aflibercept 2 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 4 | 153 Participants |
| Aflibercept 2 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 8 | 166 Participants |
| Aflibercept 2 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 16 | 131 Participants |
| Aflibercept 2 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 20 | 118 Participants |
| Aflibercept 2 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 24 | 114 Participants |
| Aflibercept 2 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 28 | 103 Participants |
| Aflibercept 2 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 32 | 97 Participants |
| Aflibercept 2 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 36 | 91 Participants |
| Aflibercept 2 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 40 | 92 Participants |
| Aflibercept 2 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 44 | 93 Participants |
| Aflibercept 2 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 48 | 97 Participants |
| Aflibercept 2 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 52 | 95 Participants |
| Aflibercept 2 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 56 | 91 Participants |
| Aflibercept 2 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 60 | 90 Participants |
| Aflibercept 2 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 64 | 90 Participants |
| Aflibercept 2 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 68 | 79 Participants |
| Aflibercept 2 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 72 | 76 Participants |
| Aflibercept 2 mg | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 | Week 12 | 155 Participants |
Secondary
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76
Presence of retinal fluid (intra- and/or subretinal fluid) assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)
Time frame: Every 4 weeks from baseline up to Week 76
Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had data at each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 24 | 35 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 44 | 43 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 16 | 34 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 48 | 44 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 28 | 47 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 52 | 34 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 12 | 41 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 56 | 34 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 32 | 58 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 60 | 39 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 20 | 33 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 64 | 31 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 36 | 48 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 68 | 34 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 8 | 56 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 72 | 33 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 40 | 42 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 76 | 16 Participants |
| Brolucizumab 6 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 4 | 83 Participants |
| Aflibercept 2 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 76 | 38 Participants |
| Aflibercept 2 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 4 | 101 Participants |
| Aflibercept 2 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 8 | 68 Participants |
| Aflibercept 2 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 12 | 49 Participants |
| Aflibercept 2 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 16 | 50 Participants |
| Aflibercept 2 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 20 | 45 Participants |
| Aflibercept 2 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 24 | 42 Participants |
| Aflibercept 2 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 28 | 56 Participants |
| Aflibercept 2 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 32 | 50 Participants |
| Aflibercept 2 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 36 | 57 Participants |
| Aflibercept 2 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 40 | 56 Participants |
| Aflibercept 2 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 44 | 54 Participants |
| Aflibercept 2 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 48 | 49 Participants |
| Aflibercept 2 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 52 | 57 Participants |
| Aflibercept 2 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 56 | 54 Participants |
| Aflibercept 2 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 60 | 63 Participants |
| Aflibercept 2 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 64 | 52 Participants |
| Aflibercept 2 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 68 | 52 Participants |
| Aflibercept 2 mg | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 | Week 72 | 39 Participants |
Secondary
Time to Recurrence After Week 20 and up to Week 76
Recurrence is defined as the need for injection while showing a lack of disease stability for the first time after Week 20 and up to Week 76. For subjects with recurrence after the Week 20 visit, time-to-event is calculated as (first time with the lack of disease stability - the injection date on Week 20 visit + 1). For subjects without recurrence after Week 20, the censoring time will be calculated as (last visit with disease stability assessment - the injection date on Week 20 visit + 1).
Time frame: Week 20 to Week 76
Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed is the number of subjects from the FAS who did not discontinue from study treatment on or before Week 20.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Brolucizumab 6 mg | Time to Recurrence After Week 20 and up to Week 76 | 12.9 Weeks |
| Aflibercept 2 mg | Time to Recurrence After Week 20 and up to Week 76 | 13.1 Weeks |