Diabetic Macular Edema
Conditions
Keywords
Diabetic Macular Edema, intravitreal injection, brolucizumab, aflibercept, double-masked, Diabetic Macular edema (DME), macular edema, diabetic retinopathy
Brief summary
The purpose of this study was to evaluate the efficacy and safety of brolucizumab vs. aflibercept in the treatment of patients with visual impairment due to diabetic macular edema (DME).
Detailed description
This study was designed as a Phase III, multi-center, randomized, double-masked, active controlled, parallel group prospective study to evaluate if brolucizumab 6 mg dosed q4w is safe and effective in the treatment of subjects with visual impairment due to diabetic macular edema (DME). Subjects who met all the inclusion and none of the exclusion criteria were randomized in a 2:1 ratio to one of two treatment arms i.e., brolucizumab 6 mg and aflibercept 2 mg. Only one eye was selected as study eye and treated with study medication. The study included a screening period of up to 2 weeks to assess eligibility, followed by a double-masked treatment period (Day 1 to Week 48). For all subjects, the last study assessment was performed at the Week 52/end of study (EOS) visit. All subjects had study visits q4w through Week 52. The primary analysis was performed at the EOS visit (Week 52). To ensure masking was maintained, the investigational site had both masked and unmasked staff to perform the masked and unmasked study assessments/procedures accordingly.
Interventions
DRUGBrolucizumab
Intravitreal injection
DRUGAflibercept
Intravitreal injection
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 will be responsible for all aspects of the study except the injections and the safety assessment following the injections. An unmasked treating investigator was to perform the injections and assess 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 type 1 or type 2 diabetes mellitus (DM) and Hemoglobin A1c (HbA1c) ≤ 12% at screening. * Study eye: Visual impairment due to DME with: * Best-corrected visual acuity (BCVA) score between 73 and 23 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters * DME involving the center of the macula, with Central Subfield Thickness (CSFT) ≥ 320 µm on Spectral Domain Optical Coherence Tomography (SD-OCT)
Exclusion criteria
* High-risk proliferative diabetic retinopathy (PDR) in the study eye * Concomitant conditions or ocular disorders in the study eye which confound interpretation of study results, compromise visual acuity or require medical or surgical intervention * Any active intraocular or periocular infection or active intraocular inflammation in the either eye * Uncontrolled glaucoma in the study eye * Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA \<20/200 * Use of anti-VEGF therapies, intraocular surgery or laser photocoagulation (macular or panretinal) in the study eye during the 3-month period prior to baseline * Use of intraocular or periocular corticosteroids in the study eye during the 6-month period prior to baseline, and use of fluocinolone acetonide intravitreal (IVT) implant (Iluvien) at any time prior to baseline * Prior investigational drugs in either eye, vitreoretinal surgery in the study eye at any time prior to baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 | Baseline, Week 52 | BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 23 (per the inclusion criteria) (approximate Snellen equivalent of 20/40 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 | Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with simultaneous absence of SRF and IRF in the study eye by visit. Events and censoring after 52 weeks are included in week 52 row. |
| Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. |
| Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. Fluid status assessments after start of alternative DME treatment in the study eye are censored. Time to first fluid-free macula analysis is based on the subset of subjects with fluid present at baseline and at least one post-baseline assessment. Time (week) was calculated by (study day / 7). Events and censoring after 52 weeks were included in week 52 row. |
| Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. Fluid status assessments after start of alternative DME treatment in the study eye are censored. Time to first fluid-free macula analysis is based on the subset of subjects with fluid present at baseline and at least one post-baseline assessment. Time (week) was calculated by (study day / 7). Events and censoring after 52 weeks were included in week 52 row. |
| Gain in Best-corrected Visual Acuity (BCVA) (Letters Read): Number (%) of Subjects Who Gained ≥ 5, 10, or 15 Letters in BCVA From Baseline or Reached BCVA ≥ 84 Letters in the Study Eye at Week 52 | Baseline, Week 52 | BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 23 (per the inclusion criteria) (approximate Snellen equivalent of 20/40 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. |
| Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. CSFT assessments after start of alternative DME treatment in the study eye are censored. Time to first absence of DME based on subjects with valid baseline and at least one post-baseline CSFT assessment. Time (week) was calculated by (study day / 7). Events and censoring after 52 weeks were included in week 52 row. |
| Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 | Central Subfield Thickness assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. |
| Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 | BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 23 (per the inclusion criteria) (approximate Snellen equivalent of 20/40 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. |
| Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye | Baseline, Weeks 12, 24 and 52 | The Diabetic Retinopathy Disease Severity Scale measures the 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative. Severity of Diabetic retinopathy was evaluated using the ETDRS DRSS score assessed by the Central Reading Center based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on the original scale with scores varying from 10 (DR absent) to 85 (very advanced PDR). All DRSS values were then converted into a 12-level scale, allowing the derivation of the ≥2-step and ≥3-step change from baseline for each post-baseline assessment. A lower score represents better functioning. Subjects who had full/partial panretinal photocoagulation or local photocoagulation for new vessel (DRSS score 60) at any visit were excluded. DRSS scores after start of alternative DME treatment in the study eye are censored and replaced by the last value prior to start of this alternative treatment. |
| Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye | Baseline, Weeks 12, 24 and 52 | The Diabetic Retinopathy Disease Severity Scale measures the 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative. Severity of Diabetic retinopathy was evaluated using the ETDRS DRSS score assessed by the Central Reading Center based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on the original scale with scores varying from 10 (DR absent) to 85 (very advanced PDR). All DRSS values were then converted into a 12-level scale, allowing the derivation of the ≥2-step and ≥3-step change from baseline for each post-baseline assessment. A lower score represents better functioning. Subjects who had full/partial panretinal photocoagulation or local photocoagulation for new vessel (DRSS score 60) at any visit were excluded. DRSS scores after start of alternative DME treatment in the study eye are censored and replaced by the last value prior to start of this alternative treatment. |
| Anti-Drug Antibody (ADA): Frequency Distribution of Pre-existing ADA Status in the Brolucizumab Arm | Baseline | — |
| Ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term in the Study Eye | Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 52 weeks. | — |
| Number of Subjects With Non-ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) | Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 52 weeks. | — |
| Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52 | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. CSFT assessments after start of alternative DME treatment in the study eye are censored. Time to first absence of DME based on subjects with valid baseline and at least one post-baseline CSFT assessment. Time (week) was calculated by (study day / 7). Events and censoring after 52 weeks were included in week 52 row. |
Countries
Hungary, Israel, Puerto Rico, Slovakia, United States
Participant flow
Recruitment details
Study centers (no. of sites): Hungary (5), Israel (5), Slovakia (7), United States (78). Approximately, 495 subjects were planned to be randomized. Overall, 517 subjects were randomized either to brolucizumab 6 mg q4w arm (n=346) or aflibercept 2 mg q4w arm (n=171).
Pre-assignment details
The study included a screening period of up to 2 weeks to assess eligibility, followed by a double-masked treatment period (Day 1 to Week 48). For all subjects, the last study assessment was performed at the Week 52/end of study (EOS) visit. All subjects had study visits q4w through Week 52. The primary analysis was performed at the EOS visit (Week 52).
Participants by arm
| Arm | Count |
|---|---|
| Brolucizumab 6mg q4w Brolucizumab 6 mg/0.05 mL every 4 weeks. | 346 |
| Aflibercept 2mg q4w Aflibercept 2mg/0.05 mL every 4 weeks | 171 |
| Total | 517 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 1 |
| Overall Study | Death | 7 | 5 |
| Overall Study | Lost to Follow-up | 10 | 5 |
| Overall Study | Physician Decision | 4 | 0 |
| Overall Study | Withdrawal by Subject | 11 | 4 |
Baseline characteristics
| Characteristic | Brolucizumab 6mg q4w | Aflibercept 2mg q4w | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 138 Participants | 56 Participants | 194 Participants |
| Age, Categorical Between 18 and 65 years | 208 Participants | 115 Participants | 323 Participants |
| Age, Continuous | 60.9 years STANDARD_DEVIATION 10.59 | 60.2 years STANDARD_DEVIATION 9.31 | 60.7 years STANDARD_DEVIATION 10.18 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 14 Participants | 7 Participants | 21 Participants |
| Race (NIH/OMB) Black or African American | 40 Participants | 15 Participants | 55 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) White | 288 Participants | 145 Participants | 433 Participants |
| Sex: Female, Male Female | 152 Participants | 66 Participants | 218 Participants |
| Sex: Female, Male Male | 194 Participants | 105 Participants | 299 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 7 / 346 | 5 / 171 | 12 / 517 |
| other Total, other adverse events | 144 / 346 | 92 / 171 | 236 / 517 |
| serious Total, serious adverse events | 74 / 346 | 36 / 171 | 110 / 517 |
Outcome results
Primary
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52
BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 23 (per the inclusion criteria) (approximate Snellen equivalent of 20/40 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values.
Time frame: Baseline, Week 52
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Brolucizumab 6mg q4w | Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 | 12.2 Scores on a scale |
| Aflibercept 2mg q4w | Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 | 11.0 Scores on a scale |
p-value: 0.09995% CI: [-0.6, 2.9]ANOVA
p-value: <0.001ANOVA
Secondary
Anti-Drug Antibody (ADA): Frequency Distribution of Pre-existing ADA Status in the Brolucizumab Arm
Time frame: Baseline
Population: Safety Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6mg q4w | Anti-Drug Antibody (ADA): Frequency Distribution of Pre-existing ADA Status in the Brolucizumab Arm | Negative | 112 Participants |
| Brolucizumab 6mg q4w | Anti-Drug Antibody (ADA): Frequency Distribution of Pre-existing ADA Status in the Brolucizumab Arm | Positive | 230 Participants |
Secondary
Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye
BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 23 (per the inclusion criteria) (approximate Snellen equivalent of 20/40 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning.
Time frame: Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Brolucizumab 6mg q4w | Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | Week 12 | 9.1 scores on a scale |
| Brolucizumab 6mg q4w | Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | Week 32 | 11.5 scores on a scale |
| Brolucizumab 6mg q4w | Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | Week 20 | 10.2 scores on a scale |
| Brolucizumab 6mg q4w | Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | Week 36 | 11.6 scores on a scale |
| Brolucizumab 6mg q4w | Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | Week 8 | 7.7 scores on a scale |
| Brolucizumab 6mg q4w | Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | Week 40 | 11.7 scores on a scale |
| Brolucizumab 6mg q4w | Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | Week 24 | 10.7 scores on a scale |
| Brolucizumab 6mg q4w | Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | Week 44 | 12.0 scores on a scale |
| Brolucizumab 6mg q4w | Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | Week 16 | 9.6 scores on a scale |
| Brolucizumab 6mg q4w | Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | Week 48 | 12.2 scores on a scale |
| Brolucizumab 6mg q4w | Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | Week 28 | 10.9 scores on a scale |
| Brolucizumab 6mg q4w | Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | Week 52 | 12.2 scores on a scale |
| Brolucizumab 6mg q4w | Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | Week 4 | 5.7 scores on a scale |
| Aflibercept 2mg q4w | Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | Week 52 | 11.0 scores on a scale |
| Aflibercept 2mg q4w | Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | Week 4 | 5.4 scores on a scale |
| Aflibercept 2mg q4w | Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | Week 8 | 7.4 scores on a scale |
| Aflibercept 2mg q4w | Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | Week 12 | 8.0 scores on a scale |
| Aflibercept 2mg q4w | Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | Week 16 | 8.5 scores on a scale |
| Aflibercept 2mg q4w | Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | Week 20 | 9.2 scores on a scale |
| Aflibercept 2mg q4w | Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | Week 24 | 9.6 scores on a scale |
| Aflibercept 2mg q4w | Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | Week 28 | 10.7 scores on a scale |
| Aflibercept 2mg q4w | Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | Week 32 | 10.5 scores on a scale |
| Aflibercept 2mg q4w | Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | Week 36 | 10.8 scores on a scale |
| Aflibercept 2mg q4w | Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | Week 40 | 10.7 scores on a scale |
| Aflibercept 2mg q4w | Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | Week 44 | 10.6 scores on a scale |
| Aflibercept 2mg q4w | Best Corrected Visual Acuity (Letters Read): Change From Baseline in Best-corrected Visual Acuity (BCVA) at Each Post-baseline Visit for the Study Eye | Week 48 | 10.7 scores on a scale |
Secondary
Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit
Central Subfield Thickness assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.
Time frame: Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Brolucizumab 6mg q4w | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Week 12 | -191.3 μm |
| Brolucizumab 6mg q4w | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Week 32 | -227.2 μm |
| Brolucizumab 6mg q4w | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Week 20 | -209.5 μm |
| Brolucizumab 6mg q4w | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Week 36 | -229.7 μm |
| Brolucizumab 6mg q4w | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Week 8 | -174.4 μm |
| Brolucizumab 6mg q4w | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Week 40 | -233.6 μm |
| Brolucizumab 6mg q4w | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Week 24 | -217.5 μm |
| Brolucizumab 6mg q4w | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Week 44 | -237.5 μm |
| Brolucizumab 6mg q4w | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Week 16 | -200.5 μm |
| Brolucizumab 6mg q4w | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Week 48 | -237.7 μm |
| Brolucizumab 6mg q4w | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Week 28 | -222.4 μm |
| Brolucizumab 6mg q4w | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Week 52 | -237.8 μm |
| Brolucizumab 6mg q4w | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Week 4 | -146.9 μm |
| Aflibercept 2mg q4w | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Week 52 | -196.5 μm |
| Aflibercept 2mg q4w | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Week 4 | -119.5 μm |
| Aflibercept 2mg q4w | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Week 8 | -144.1 μm |
| Aflibercept 2mg q4w | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Week 12 | -156.7 μm |
| Aflibercept 2mg q4w | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Week 16 | -162.4 μm |
| Aflibercept 2mg q4w | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Week 20 | -168.7 μm |
| Aflibercept 2mg q4w | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Week 24 | -178.8 μm |
| Aflibercept 2mg q4w | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Week 28 | -183.6 μm |
| Aflibercept 2mg q4w | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Week 32 | -185.9 μm |
| Aflibercept 2mg q4w | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Week 36 | -186.7 μm |
| Aflibercept 2mg q4w | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Week 40 | -188.4 μm |
| Aflibercept 2mg q4w | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Week 44 | -188.1 μm |
| Aflibercept 2mg q4w | Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit | Week 48 | -192.0 μm |
p-value: <0.00195% CI: [-58.9, -23.8]ANOVA
Secondary
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye
The Diabetic Retinopathy Disease Severity Scale measures the 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative. Severity of Diabetic retinopathy was evaluated using the ETDRS DRSS score assessed by the Central Reading Center based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on the original scale with scores varying from 10 (DR absent) to 85 (very advanced PDR). All DRSS values were then converted into a 12-level scale, allowing the derivation of the ≥2-step and ≥3-step change from baseline for each post-baseline assessment. A lower score represents better functioning. Subjects who had full/partial panretinal photocoagulation or local photocoagulation for new vessel (DRSS score 60) at any visit were excluded. DRSS scores after start of alternative DME treatment in the study eye are censored and replaced by the last value prior to start of this alternative treatment.
Time frame: Baseline, Weeks 12, 24 and 52
Population: Full analysis set (FAS) - Last observation carried forward (LOCF). Subjects who had full/partial panretinal photocoagulation or local photocoagulation for new vessel (DRSS score 60) at any visit were excluded from analysis.~DRSS scores after start of alternative DME treatment in the study eye are censored and replaced by the last value prior to start of this alternative treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6mg q4w | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye | Week 12 | 56 Participants |
| Brolucizumab 6mg q4w | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye | Week 24 | 82 Participants |
| Brolucizumab 6mg q4w | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye | Week 52 | 95 Participants |
| Aflibercept 2mg q4w | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye | Week 12 | 21 Participants |
| Aflibercept 2mg q4w | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye | Week 24 | 38 Participants |
| Aflibercept 2mg q4w | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye | Week 52 | 45 Participants |
95% CI: [0.2, 16.5]Clopper-Pearson exact method
95% CI: [-3, 14.9]Clopper-Pearson exact method
p-value: 0.00295% CI: [-3.9, 16.1]Clopper-Pearson exact method
Secondary
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye
The Diabetic Retinopathy Disease Severity Scale measures the 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative. Severity of Diabetic retinopathy was evaluated using the ETDRS DRSS score assessed by the Central Reading Center based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on the original scale with scores varying from 10 (DR absent) to 85 (very advanced PDR). All DRSS values were then converted into a 12-level scale, allowing the derivation of the ≥2-step and ≥3-step change from baseline for each post-baseline assessment. A lower score represents better functioning. Subjects who had full/partial panretinal photocoagulation or local photocoagulation for new vessel (DRSS score 60) at any visit were excluded. DRSS scores after start of alternative DME treatment in the study eye are censored and replaced by the last value prior to start of this alternative treatment.
Time frame: Baseline, Weeks 12, 24 and 52
Population: Full analysis set (FAS) - Last observation carried forward (LOCF). Subjects who had full/partial panretinal photocoagulation or local photocoagulation for new vessel (DRSS score 60) at any visit were excluded from analysis.~DRSS scores after start of alternative DME treatment in the study eye are censored and replaced by the last value prior to start of this alternative treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6mg q4w | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye | Week 12 | 18 Participants |
| Brolucizumab 6mg q4w | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye | Week 24 | 33 Participants |
| Brolucizumab 6mg q4w | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye | Week 52 | 40 Participants |
| Aflibercept 2mg q4w | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye | Week 12 | 8 Participants |
| Aflibercept 2mg q4w | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye | Week 24 | 16 Participants |
| Aflibercept 2mg q4w | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye | Week 52 | 18 Participants |
95% CI: [-2.5, 6.6]Clopper-Pearson exact method
95% CI: [-3, 7.7]Clopper-Pearson exact method
95% CI: [-2, 9.8]Clopper-Pearson exact method
Secondary
Gain in Best-corrected Visual Acuity (BCVA) (Letters Read): Number (%) of Subjects Who Gained ≥ 5, 10, or 15 Letters in BCVA From Baseline or Reached BCVA ≥ 84 Letters in the Study Eye at Week 52
BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 23 (per the inclusion criteria) (approximate Snellen equivalent of 20/40 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning.
Time frame: Baseline, Week 52
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6mg q4w | Gain in Best-corrected Visual Acuity (BCVA) (Letters Read): Number (%) of Subjects Who Gained ≥ 5, 10, or 15 Letters in BCVA From Baseline or Reached BCVA ≥ 84 Letters in the Study Eye at Week 52 | ≥ 5 letters gain from baseline or BCVA ≥ 84 letters at Week 52 | 286 Participants |
| Brolucizumab 6mg q4w | Gain in Best-corrected Visual Acuity (BCVA) (Letters Read): Number (%) of Subjects Who Gained ≥ 5, 10, or 15 Letters in BCVA From Baseline or Reached BCVA ≥ 84 Letters in the Study Eye at Week 52 | ≥ 10 letters gain from baseline or BCVA ≥ 84 letters at Week 52 | 211 Participants |
| Brolucizumab 6mg q4w | Gain in Best-corrected Visual Acuity (BCVA) (Letters Read): Number (%) of Subjects Who Gained ≥ 5, 10, or 15 Letters in BCVA From Baseline or Reached BCVA ≥ 84 Letters in the Study Eye at Week 52 | ≥ 15 letters gain from baseline or BCVA ≥ 84 letters at Week 52 | 151 Participants |
| Aflibercept 2mg q4w | Gain in Best-corrected Visual Acuity (BCVA) (Letters Read): Number (%) of Subjects Who Gained ≥ 5, 10, or 15 Letters in BCVA From Baseline or Reached BCVA ≥ 84 Letters in the Study Eye at Week 52 | ≥ 5 letters gain from baseline or BCVA ≥ 84 letters at Week 52 | 127 Participants |
| Aflibercept 2mg q4w | Gain in Best-corrected Visual Acuity (BCVA) (Letters Read): Number (%) of Subjects Who Gained ≥ 5, 10, or 15 Letters in BCVA From Baseline or Reached BCVA ≥ 84 Letters in the Study Eye at Week 52 | ≥ 10 letters gain from baseline or BCVA ≥ 84 letters at Week 52 | 95 Participants |
| Aflibercept 2mg q4w | Gain in Best-corrected Visual Acuity (BCVA) (Letters Read): Number (%) of Subjects Who Gained ≥ 5, 10, or 15 Letters in BCVA From Baseline or Reached BCVA ≥ 84 Letters in the Study Eye at Week 52 | ≥ 15 letters gain from baseline or BCVA ≥ 84 letters at Week 52 | 69 Participants |
Comparison: ≥ 15 letters gain from baseline or BCVA ≥ 84 letters at Week 5295% CI: [-2.7, 14.3]Clopper-Pearson exact method
Comparison: ≥ 5 letters gain from baseline or BCVA ≥ 84 letters at Week 5295% CI: [1.7, 17]Clopper-Pearson exact method
Comparison: ≥ 10 letters gain from baseline or BCVA ≥ 84 letters at Week 5295% CI: [-1.5, 17]Clopper-Pearson exact method
Secondary
Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye
Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.
Time frame: Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6mg q4w | Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Week 4 | 61 Participants |
| Brolucizumab 6mg q4w | Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Week 8 | 93 Participants |
| Brolucizumab 6mg q4w | Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Week 12 | 124 Participants |
| Brolucizumab 6mg q4w | Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Week 16 | 147 Participants |
| Brolucizumab 6mg q4w | Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Week 20 | 167 Participants |
| Brolucizumab 6mg q4w | Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Week 24 | 177 Participants |
| Brolucizumab 6mg q4w | Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Week 28 | 186 Participants |
| Brolucizumab 6mg q4w | Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Week 32 | 195 Participants |
| Brolucizumab 6mg q4w | Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Week 36 | 206 Participants |
| Brolucizumab 6mg q4w | Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Week 40 | 211 Participants |
| Brolucizumab 6mg q4w | Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Week 44 | 216 Participants |
| Brolucizumab 6mg q4w | Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Week 48 | 222 Participants |
| Brolucizumab 6mg q4w | Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Week 52 | 229 Participants |
| Aflibercept 2mg q4w | Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Week 44 | 69 Participants |
| Aflibercept 2mg q4w | Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Week 4 | 9 Participants |
| Aflibercept 2mg q4w | Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Week 32 | 62 Participants |
| Aflibercept 2mg q4w | Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Week 8 | 24 Participants |
| Aflibercept 2mg q4w | Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Week 52 | 71 Participants |
| Aflibercept 2mg q4w | Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Week 12 | 33 Participants |
| Aflibercept 2mg q4w | Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Week 36 | 63 Participants |
| Aflibercept 2mg q4w | Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Week 16 | 42 Participants |
| Aflibercept 2mg q4w | Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Week 48 | 68 Participants |
| Aflibercept 2mg q4w | Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Week 20 | 47 Participants |
| Aflibercept 2mg q4w | Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Week 40 | 65 Participants |
| Aflibercept 2mg q4w | Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Week 24 | 52 Participants |
| Aflibercept 2mg q4w | Number and Percentage of Participants With Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) at Each Post-baseline Visit for the Study Eye | Week 28 | 57 Participants |
Secondary
Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit
Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with simultaneous absence of SRF and IRF in the study eye by visit. Events and censoring after 52 weeks are included in week 52 row.
Time frame: Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52
Population: Full analysis set (FAS) - Last observation carried forward (LOCF).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6mg q4w | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | Week 12 | 38 Participants |
| Brolucizumab 6mg q4w | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | Week 32 | 76 Participants |
| Brolucizumab 6mg q4w | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | Week 20 | 54 Participants |
| Brolucizumab 6mg q4w | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | Week 36 | 91 Participants |
| Brolucizumab 6mg q4w | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | Week 8 | 31 Participants |
| Brolucizumab 6mg q4w | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | Week 40 | 96 Participants |
| Brolucizumab 6mg q4w | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | Week 24 | 84 Participants |
| Brolucizumab 6mg q4w | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | Week 44 | 96 Participants |
| Brolucizumab 6mg q4w | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | Week 16 | 48 Participants |
| Brolucizumab 6mg q4w | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | week 48 | 92 Participants |
| Brolucizumab 6mg q4w | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | Week 28 | 65 Participants |
| Brolucizumab 6mg q4w | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | Week 52 | 144 Participants |
| Brolucizumab 6mg q4w | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | Week 4 | 23 Participants |
| Aflibercept 2mg q4w | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | Week 52 | 38 Participants |
| Aflibercept 2mg q4w | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | Week 4 | 4 Participants |
| Aflibercept 2mg q4w | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | Week 8 | 4 Participants |
| Aflibercept 2mg q4w | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | Week 12 | 10 Participants |
| Aflibercept 2mg q4w | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | Week 16 | 11 Participants |
| Aflibercept 2mg q4w | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | Week 20 | 9 Participants |
| Aflibercept 2mg q4w | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | Week 24 | 19 Participants |
| Aflibercept 2mg q4w | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | Week 28 | 13 Participants |
| Aflibercept 2mg q4w | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | Week 32 | 17 Participants |
| Aflibercept 2mg q4w | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | Week 36 | 21 Participants |
| Aflibercept 2mg q4w | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | Week 40 | 23 Participants |
| Aflibercept 2mg q4w | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | Week 44 | 20 Participants |
| Aflibercept 2mg q4w | Number and Percentage of Participants With Fluid-free Macula in the Study Eye at Each Post-baseline Visit | week 48 | 23 Participants |
p-value: <0.00195% CI: [12.5, 28.6]Clopper-Pearson exact method.
Secondary
Number of Subjects With Non-ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm)
Time frame: Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 52 weeks.
Population: Safety Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brolucizumab 6mg q4w | Number of Subjects With Non-ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) | 209 Participants |
| Aflibercept 2mg q4w | Number of Subjects With Non-ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) | 96 Participants |
Secondary
Ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term in the Study Eye
Time frame: Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 52 weeks.
Population: Safety Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6mg q4w | Ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term in the Study Eye | Punctate keratitis | 9 Participants |
| Brolucizumab 6mg q4w | Ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term in the Study Eye | Dry eye | 7 Participants |
| Brolucizumab 6mg q4w | Ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term in the Study Eye | Conjunctival haemorrhage | 9 Participants |
| Brolucizumab 6mg q4w | Ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term in the Study Eye | Eye pain | 6 Participants |
| Brolucizumab 6mg q4w | Ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term in the Study Eye | Uveitis | 8 Participants |
| Brolucizumab 6mg q4w | Ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term in the Study Eye | Corneal abrasion | 0 Participants |
| Brolucizumab 6mg q4w | Ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term in the Study Eye | Vitreous detachment | 10 Participants |
| Brolucizumab 6mg q4w | Ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term in the Study Eye | Diabetic retinal oedema | 0 Participants |
| Brolucizumab 6mg q4w | Ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term in the Study Eye | Vitreous floaters | 8 Participants |
| Brolucizumab 6mg q4w | Ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term in the Study Eye | Cataract | 9 Participants |
| Brolucizumab 6mg q4w | Ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term in the Study Eye | Number of subjects with at least one AE | 105 Participants |
| Aflibercept 2mg q4w | Ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term in the Study Eye | Vitreous floaters | 5 Participants |
| Aflibercept 2mg q4w | Ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term in the Study Eye | Vitreous detachment | 7 Participants |
| Aflibercept 2mg q4w | Ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term in the Study Eye | Cataract | 6 Participants |
| Aflibercept 2mg q4w | Ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term in the Study Eye | Conjunctival haemorrhage | 7 Participants |
| Aflibercept 2mg q4w | Ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term in the Study Eye | Punctate keratitis | 2 Participants |
| Aflibercept 2mg q4w | Ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term in the Study Eye | Uveitis | 1 Participants |
| Aflibercept 2mg q4w | Ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term in the Study Eye | Number of subjects with at least one AE | 59 Participants |
| Aflibercept 2mg q4w | Ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term in the Study Eye | Dry eye | 4 Participants |
| Aflibercept 2mg q4w | Ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term in the Study Eye | Eye pain | 5 Participants |
| Aflibercept 2mg q4w | Ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term in the Study Eye | Corneal abrasion | 5 Participants |
| Aflibercept 2mg q4w | Ocular AEs (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term in the Study Eye | Diabetic retinal oedema | 4 Participants |
Secondary
Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit
Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. CSFT assessments after start of alternative DME treatment in the study eye are censored. Time to first absence of DME based on subjects with valid baseline and at least one post-baseline CSFT assessment. Time (week) was calculated by (study day / 7). Events and censoring after 52 weeks were included in week 52 row.
Time frame: Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Probability of absence of DME at Week 0 (n=346,171) | 0.000 Probability of absence of DME |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Probability of absence of DME at Week 4 (n=346,171) | 0.041 Probability of absence of DME |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Probability of absence of DME at Week 8 (n=329,169) | 0.199 Probability of absence of DME |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Probability of absence of DME at Week 12 (n=272, 157) | 0.293 Probability of absence of DME |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Probability of absence of DME at Week 16 (n=239, 142) | 0.391 Probability of absence of DME |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Probability of absence of DME at Week 20 (n=204, 130) | 0.470 Probability of absence of DME |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Probability of absence of DME at Week 24 (n=174,120) | 0.506 Probability of absence of DME |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Probability of absence of DME at Week 28 (n=161,115) | 0.547 Probability of absence of DME |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Probability of absence of DME at Week 32 (n=146,107) | 0.575 Probability of absence of DME |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Probability of absence of DMEE at Week 36 (n=135,102) | 0.606 Probability of absence of DME |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Probability of absence of DME at Week 40 (n=125, 98) | 0.628 Probability of absence of DME |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Probability of absence of DME at Week 44 (117, 96) | 0.663 Probability of absence of DME |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Probability of absence of DME at Week 48 (n=106, 92) | 0.682 Probability of absence of DME |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Probability of absence of DME at Week 52 (n=99, 88) | 0.866 Probability of absence of DME |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Probability of absence of DME at Week 40 (n=125, 98) | 0.395 Probability of absence of DME |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Probability of absence of DME at Week 0 (n=346,171) | 0.000 Probability of absence of DME |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Probability of absence of DME at Week 28 (n=161,115) | 0.346 Probability of absence of DME |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Probability of absence of DME at Week 4 (n=346,171) | 0.006 Probability of absence of DME |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Probability of absence of DME at Week 48 (n=106, 92) | 0.427 Probability of absence of DME |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Probability of absence of DME at Week 8 (n=329,169) | 0.076 Probability of absence of DME |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Probability of absence of DME at Week 32 (n=146,107) | 0.376 Probability of absence of DME |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Probability of absence of DME at Week 12 (n=272, 157) | 0.153 Probability of absence of DME |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Probability of absence of DME at Week 44 (117, 96) | 0.408 Probability of absence of DME |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Probability of absence of DME at Week 16 (n=239, 142) | 0.219 Probability of absence of DME |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Probability of absence of DMEE at Week 36 (n=135,102) | 0.389 Probability of absence of DME |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Probability of absence of DME at Week 20 (n=204, 130) | 0.279 Probability of absence of DME |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Probability of absence of DME at Week 52 (n=99, 88) | 0.516 Probability of absence of DME |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Kaplan-Meier Analysis - Probability of Absence of DME by Visit | Probability of absence of DME at Week 24 (n=174,120) | 0.303 Probability of absence of DME |
Secondary
Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit
Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. CSFT assessments after start of alternative DME treatment in the study eye are censored. Time to first absence of DME based on subjects with valid baseline and at least one post-baseline CSFT assessment. Time (week) was calculated by (study day / 7). Events and censoring after 52 weeks were included in week 52 row.
Time frame: Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number censored at Week 0 (n=346,171) | 0 Participants |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number of subjects with Probability of absence of DME at Week 16 (n=239, 142) | 33 Participants |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number censored at Week 4 (n=346,171) | 3 Participants |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number of subjects with Probability of absence of DME at Week 32 (n=146,107) | 9 Participants |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number censored at Week 8 (n=329,169) | 3 Participants |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number of subjects with Probability of absence of DME at Week 4 (n=346,171) | 14 Participants |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number censored at Week 12 (n=272, 157) | 1 Participants |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number of subjects with Probability of absence of DME at Week 36 (n=135,102) | 10 Participants |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number censored at Week 16 (n=239, 142) | 2 Participants |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number of subjects with Probability of absence of DME at Week 20 (n=204, 130) | 26 Participants |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number censored at Week 20 (n=204, 130) | 4 Participants |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number of subjects with Probability of absence of DME at Week 40 (n=125, 98) | 7 Participants |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number censored at Week 24 (n=174,120) | 1 Participants |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number of subjects with Probability of absence of DME at Week 12 (n=272, 157) | 32 Participants |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number censored at Week 28 (n=161,115) | 2 Participants |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number of subjects with Probability of absence of DME at Week 44 (117, 96) | 11 Participants |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number censored at Week 32 (n=146,107) | 2 Participants |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number of subjects with Probability of absence of DME at Week 24 (n=174,120) | 12 Participants |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number censored at Week 36 (n=135,102) | 0 Participants |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number of subjects with Probability of absence of DME at Week 48 (n=106, 92) | 6 Participants |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number censored at Week 40 (n=125, 98) | 1 Participants |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number of subjects with Probability of absence of DME at Week 8 (n=329,169) | 54 Participants |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number censored at Week 44 (117, 96) | 0 Participants |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number of subjects with Probability of absence of DME at Week 52 (n=99, 88) | 13 Participants |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number censored at Week 48 (n=106, 92) | 1 Participants |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number of subjects with Probability of absence of DME at Week 28 (n=161,115) | 13 Participants |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number censored at Week 52 (n=99, 88) | 86 Participants |
| Brolucizumab 6mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number of subjects with Probability of absence of DME at Week 0 (n=346,171) | 0 Participants |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number censored at Week 52 (n=99, 88) | 84 Participants |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number of subjects with Probability of absence of DME at Week 0 (n=346,171) | 0 Participants |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number of subjects with Probability of absence of DME at Week 4 (n=346,171) | 1 Participants |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number of subjects with Probability of absence of DME at Week 8 (n=329,169) | 12 Participants |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number of subjects with Probability of absence of DME at Week 12 (n=272, 157) | 13 Participants |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number of subjects with Probability of absence of DME at Week 16 (n=239, 142) | 11 Participants |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number of subjects with Probability of absence of DME at Week 20 (n=204, 130) | 10 Participants |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number of subjects with Probability of absence of DME at Week 24 (n=174,120) | 4 Participants |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number of subjects with Probability of absence of DME at Week 28 (n=161,115) | 7 Participants |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number of subjects with Probability of absence of DME at Week 32 (n=146,107) | 5 Participants |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number of subjects with Probability of absence of DME at Week 36 (n=135,102) | 2 Participants |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number of subjects with Probability of absence of DME at Week 40 (n=125, 98) | 1 Participants |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number of subjects with Probability of absence of DME at Week 44 (117, 96) | 2 Participants |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number of subjects with Probability of absence of DME at Week 48 (n=106, 92) | 3 Participants |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number of subjects with Probability of absence of DME at Week 52 (n=99, 88) | 4 Participants |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number censored at Week 0 (n=346,171) | 0 Participants |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number censored at Week 4 (n=346,171) | 1 Participants |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number censored at Week 8 (n=329,169) | 0 Participants |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number censored at Week 12 (n=272, 157) | 2 Participants |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number censored at Week 16 (n=239, 142) | 1 Participants |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number censored at Week 20 (n=204, 130) | 0 Participants |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number censored at Week 24 (n=174,120) | 1 Participants |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number censored at Week 28 (n=161,115) | 1 Participants |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number censored at Week 32 (n=146,107) | 0 Participants |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number censored at Week 36 (n=135,102) | 2 Participants |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number censored at Week 40 (n=125, 98) | 1 Participants |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number censored at Week 44 (117, 96) | 2 Participants |
| Aflibercept 2mg q4w | Time to First Absence of Diabetic Macular Edema (DME) (CSFT < 280 μm) in the Study Eye at Each Post-baseline Visit - Number of Subjects With Probability of Absence of DME and Number Censored by Visit | Number censored at Week 48 (n=106, 92) | 1 Participants |
Secondary
Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit
Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. Fluid status assessments after start of alternative DME treatment in the study eye are censored. Time to first fluid-free macula analysis is based on the subset of subjects with fluid present at baseline and at least one post-baseline assessment. Time (week) was calculated by (study day / 7). Events and censoring after 52 weeks were included in week 52 row.
Time frame: Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52
Population: Full Analysis Set. Time to first fluid-free macula analysis is based on the subset of subjects with fluid present at baseline and at least one post-baseline assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Probability of absence of SRF/IRF at Week 0 (n=344,170) | 0.000 Probability of absence of SRF/IRF |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Probability of absence of SRF/IRF at Week 4 (n=344,170) | 0.018 Probability of absence of SRF/IRF |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Probability of absence of SRF/IRF at Week 8 (n=335,168) | 0.071 Probability of absence of SRF/IRF |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Probability of absence of SRF/IRF at Week 12 (n=314, 165) | 0.109 Probability of absence of SRF/IRF |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Probability of absence of SRF/IRF at Week 16 (n=297, 161) | 0.161 Probability of absence of SRF/IRF |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Probability of absence of SRF/IRF at Week 20 (n=277, 156) | 0.185 Probability of absence of SRF/IRF |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Probability of absence of SRF/IRF at Week 24 (n=265,150) | 0.234 Probability of absence of SRF/IRF |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Probability of absence of SRF/IRF at Week 28 (n=246,146) | 0.291 Probability of absence of SRF/IRF |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Probability of absence of SRF/IRF at Week 32 (n=224,139) | 0.300 Probability of absence of SRF/IRF |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Probability of absence of SRF/IRF at Week 36 (n=220,138) | 0.326 Probability of absence of SRF/IRF |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Probability of absence of SRF/IRF at Week 40 (n=211, 134) | 0.377 Probability of absence of SRF/IRF |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Probability of absence of SRF/IRF at Week 44 (194, 129) | 0.412 Probability of absence of SRF/IRF |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Probability of absence of SRF/IRF at Week 48 (n=181, 125) | 0.422 Probability of absence of SRF/IRF |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Probability of absence of SRF/IRF at Week 52 (n=177, 122) | 0.653 Probability of absence of SRF/IRF |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Probability of absence of SRF/IRF at Week 40 (n=211, 134) | 0.194 Probability of absence of SRF/IRF |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Probability of absence of SRF/IRF at Week 0 (n=344,170) | 0.000 Probability of absence of SRF/IRF |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Probability of absence of SRF/IRF at Week 28 (n=246,146) | 0.151 Probability of absence of SRF/IRF |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Probability of absence of SRF/IRF at Week 4 (n=344,170) | 0.006 Probability of absence of SRF/IRF |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Probability of absence of SRF/IRF at Week 48 (n=181, 125) | 0.206 Probability of absence of SRF/IRF |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Probability of absence of SRF/IRF at Week 8 (n=335,168) | 0.024 Probability of absence of SRF/IRF |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Probability of absence of SRF/IRF at Week 32 (n=224,139) | 0.157 Probability of absence of SRF/IRF |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Probability of absence of SRF/IRF at Week 12 (n=314, 165) | 0.036 Probability of absence of SRF/IRF |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Probability of absence of SRF/IRF at Week 44 (194, 129) | 0.206 Probability of absence of SRF/IRF |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Probability of absence of SRF/IRF at Week 16 (n=297, 161) | 0.060 Probability of absence of SRF/IRF |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Probability of absence of SRF/IRF at Week 36 (n=220,138) | 0.169 Probability of absence of SRF/IRF |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Probability of absence of SRF/IRF at Week 20 (n=277, 156) | 0.096 Probability of absence of SRF/IRF |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Probability of absence of SRF/IRF at Week 52 (n=177, 122) | 0.328 Probability of absence of SRF/IRF |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Kaplan-Meier Analysis - Probability of Absence of SRF/IRF by Visit | Probability of absence of SRF/IRF at Week 24 (n=265,150) | 0.108 Probability of absence of SRF/IRF |
Secondary
Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit
Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. Fluid status assessments after start of alternative DME treatment in the study eye are censored. Time to first fluid-free macula analysis is based on the subset of subjects with fluid present at baseline and at least one post-baseline assessment. Time (week) was calculated by (study day / 7). Events and censoring after 52 weeks were included in week 52 row.
Time frame: Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52
Population: Full Analysis Set. Time to first fluid-free macula analysis is based on the subset of subjects with fluid present at baseline and at least one post-baseline assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects with absence of SRF / IRF at Week 48 (n=181, 125) | 3 Participants |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects with absence of SRF / IRF at Week 8 (n=335,168) | 18 Participants |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects with absence of SRF / IRF at Week 52 (n=177, 122) | 30 Participants |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects with absence of SRF / IRF at Week 24 (n=265,150) | 16 Participants |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects censored at Week 0 (n=344, 170) | 0 Participants |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects censored at Week 52 (n=177, 122) | 147 Participants |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects censored at Week 4 (n-344, 170) | 3 Participants |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects with absence of SRF / IRF at Week 28 (n=246,146) | 18 Participants |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects censored at Week 8 (n=335,168) | 3 Participants |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects with absence of SRF / IRF at Week 12 (n=314, 165) | 13 Participants |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects censored at Week 12 (n=314, 165) | 4 Participants |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects with absence of SRF / IRF at Week 32 (n=224,139) | 3 Participants |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects censored at Week 16 (n=297, 161) | 3 Participants |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects with absence of SRF / IRF at Week 4 (n=344,170) | 6 Participants |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects censored at Week 20 (n=277, 156) | 4 Participants |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects with absence of SRF / IRF at Week 36 (n=220,138) | 8 Participants |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects censored at Week 24 (n=265, 150) | 3 Participants |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects with absence of SRF / IRF at Week 16 (n=297, 161) | 17 Participants |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects censored at Week 28 (n=246, 146) | 4 Participants |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects with absence of SRF / IRF at Week 40 (n=211, 134) | 16 Participants |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects censored at Week 32 (n=224,139) | 1 Participants |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects with absence of SRF / IRF at Week 0 (n=344,170) | 0 Participants |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects censored at Week 36 (220, 138) | 1 Participants |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects with absence of SRF / IRF at Week 44 (194, 129) | 11 Participants |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects censored at Week 40 (n=211,134) | 1 Participants |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects with absence of SRF / IRF at Week 20 (n=277, 156) | 8 Participants |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects censored at Week 44 (n=194,129) | 2 Participants |
| Brolucizumab 6mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects censored at Week 48 (n=181, 125) | 1 Participants |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects censored at Week 44 (n=194,129) | 2 Participants |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects censored at Week 48 (n=181, 125) | 3 Participants |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects censored at Week 52 (n=177, 122) | 110 Participants |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects with absence of SRF / IRF at Week 0 (n=344,170) | 0 Participants |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects with absence of SRF / IRF at Week 4 (n=344,170) | 1 Participants |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects with absence of SRF / IRF at Week 8 (n=335,168) | 3 Participants |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects with absence of SRF / IRF at Week 12 (n=314, 165) | 2 Participants |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects with absence of SRF / IRF at Week 16 (n=297, 161) | 4 Participants |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects with absence of SRF / IRF at Week 20 (n=277, 156) | 6 Participants |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects with absence of SRF / IRF at Week 24 (n=265,150) | 2 Participants |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects with absence of SRF / IRF at Week 28 (n=246,146) | 7 Participants |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects with absence of SRF / IRF at Week 32 (n=224,139) | 1 Participants |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects with absence of SRF / IRF at Week 36 (n=220,138) | 2 Participants |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects with absence of SRF / IRF at Week 40 (n=211, 134) | 4 Participants |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects with absence of SRF / IRF at Week 44 (194, 129) | 2 Participants |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects with absence of SRF / IRF at Week 48 (n=181, 125) | 0 Participants |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects with absence of SRF / IRF at Week 52 (n=177, 122) | 12 Participants |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects censored at Week 0 (n=344, 170) | 0 Participants |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects censored at Week 4 (n-344, 170) | 1 Participants |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects censored at Week 8 (n=335,168) | 0 Participants |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects censored at Week 12 (n=314, 165) | 2 Participants |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects censored at Week 16 (n=297, 161) | 1 Participants |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects censored at Week 20 (n=277, 156) | 0 Participants |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects censored at Week 24 (n=265, 150) | 2 Participants |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects censored at Week 28 (n=246, 146) | 0 Participants |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects censored at Week 32 (n=224,139) | 0 Participants |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects censored at Week 36 (220, 138) | 2 Participants |
| Aflibercept 2mg q4w | Time to First Fluid-free Macula - Time-to-first Absence of Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) in the Study Eye - Number of Subjects With Absence of SRF / IRF and Number of Subjects Censored by Visit | Number of subjects censored at Week 40 (n=211,134) | 1 Participants |