Wet Age-related Macular Degeneration
Conditions
Keywords
AMD, Wet AMD, neovascularization secondary to age-related macular degeneration, KSI-301, Aflibercept, Vascular endothelial growth factor, VEGF, Anti-VEGF, Antibody biopolymer conjugate, Macular Degeneration, wAMD, Retinal Degeneration, Retinal Diseases, Eye Diseases, Vision Disorders, Vision, Low, Kodiak
Brief summary
This Phase 3 study will evaluate the efficacy and safety of KSI-301 compared to aflibercept, in participants with neovascular (wet) age-related macular degeneration (wAMD)
Detailed description
This is a Phase 3, prospective, randomized, double-masked, two-arm, multi-center non-inferiority study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with visual impairment due to treatment-naïve neovascular (wet) age-related macular degeneration (wAMD) The primary endpoint will be assessed as an average of Weeks 40, 44, and 48; additional secondary endpoints for efficacy will be assessed by visit over time
Interventions
DRUGKSI-301
Intravitreal Injection
DRUGAflibercept
Intravitreal Injection
OTHERSham Procedure
The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
Sponsors
Kodiak Sciences Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
For masking purposes, sham injections will be administered at every monthly visit if an active treatment is not administered. To preserve masking, two investigators are required for this study. The masked Investigator will be responsible for the examinations and safety assessments. The unmasked Investigator will perform the injections and post-treatment assessments.
Intervention model description
Participants will be randomized 1:1 into one of two treatment arms: KSI-301 or aflibercept.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent prior to participation in the study. * Treatment-naïve choroidal neovascularization (CNV) secondary to AMD. * BCVA ETDRS score between 83 and 25 letters, inclusive, in the Study Eye. * Decrease in vision in the Study Eye determined by the Investigator to be primarily the result of wAMD. * Other protocol-specified inclusion criteria may apply
Exclusion criteria
* BCVA of hand motion or worse in the non-Study Eye or non-physical presence of a non-Study Eye (i.e., monocular). * Active or suspected ocular or periocular infection or inflammation. * CNV secondary to other causes in the Study Eye. * Any history or evidence of a concurrent ocular condition present in the Study Eye, that in the opinion of the Investigator could require either medical or surgical intervention or affect macular edema or alter visual acuity during the study. * Uncontrolled glaucoma in the Study Eye. * Significant media opacities, including cataract, in the Study Eye that might interfere with visual acuity, assessment of safety, OCT or fundus photography. * Cataract in the Study Eye that in the judgment of the Investigator is expected to require surgical extraction within 12 months of screening. * Women who are pregnant or lactating or intending to become pregnant during the study. * Recent history (within the 6 months prior to screening) of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure or any acute coronary event. * History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product. * Uncontrolled blood pressure defined as a systolic value ≥180 mmHg or diastolic value ≥100 mmHg while at rest. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to the Average of Non-missing BCVA Values of Weeks 40, 44 and 48. | Day 1 to Week 48 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Day 1 to Week 48 | Categorical improvements in Best Corrected Visual Acuity (BCVA) of clinically relevant BCVA measurements corresponding to 1, 2 and 3 lines of the ETDRS vision testing chart |
| Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Day 1 to Week 48 | Categorical worsening in Best Corrected Visual Acuity (BCVA) of clinically relevant BCVA measurements corresponding to 1, 2 and 3 lines of the ETDRS vision testing chart |
| Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Day 1 to Week 48 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. |
| Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Day 1 to Week 48 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. |
| Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Day 1 to Week 48 | Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) as assessed by a central reading center. |
| Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Day 1 to Week 48 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
Participants were recruited based on physician referral at 94 medical centers between June 2021 and April 2022. The first participant was enrolled on 23 June 2021 and the last on 07 April 2022.
Pre-assignment details
Of 815 participants screened, 557 were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| KSI-301 (Treatment Group A) Intravitreal injection of KSI-301 (5 mg) at Day 1 once every 4 weeks via intravitreal injection through Week 44.
KSI-301: Intravitreal Injection | 276 |
| Aflibercept (Treatment Group B) Intravitreal injection of aflibercept (2 mg) once every 4 weeks for 3 monthly doses followed by intravitreal injection of aflibercept (2 mg) once every 8 weeks from Week 16 to Week 44. Sham injections will be administered at each monthly visit where an active treatment is not administered.
Aflibercept: Intravitreal Injection
Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking. | 281 |
| Total | 557 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 8 | 6 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Non-compliance with study schedule | 1 | 0 |
| Overall Study | Participant decided to discontinue | 0 | 1 |
| Overall Study | Participant did not want to continue study treatment | 1 | 0 |
| Overall Study | Participant moved to different state | 1 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Progressive disease | 4 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 5 |
Baseline characteristics
| Characteristic | Aflibercept (Treatment Group B) | Total | KSI-301 (Treatment Group A) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 263 Participants | 520 Participants | 257 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 37 Participants | 19 Participants |
| Age, Continuous | 77.2 years STANDARD_DEVIATION 7.84 | 77.0 years STANDARD_DEVIATION 8.02 | 76.9 years STANDARD_DEVIATION 8.21 |
| BCVA in the Study Eye | 64.0 Letters STANDARD_DEVIATION 13.09 | 63.8 Letters STANDARD_DEVIATION 13.07 | 63.7 Letters STANDARD_DEVIATION 13.06 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 30 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 267 Participants | 527 Participants | 260 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Geographic Region North America | 228 Participants | 453 Participants | 225 Participants |
| Geographic Region Rest of World | 53 Participants | 104 Participants | 51 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 276 Participants | 545 Participants | 269 Participants |
| Sex: Female, Male Female | 180 Participants | 339 Participants | 159 Participants |
| Sex: Female, Male Male | 101 Participants | 218 Participants | 117 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 276 | 3 / 281 |
| other Total, other adverse events | 110 / 276 | 80 / 281 |
| serious Total, serious adverse events | 39 / 276 | 39 / 281 |
Outcome results
Primary
Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to the Average of Non-missing BCVA Values of Weeks 40, 44 and 48.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
Time frame: Day 1 to Week 48
Population: Full analysis set defined as all randomized subjects who received at least one treatment injection. Subjects will be analyzed according to their randomized treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| KSI-301 (Treatment Group A) | Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to the Average of Non-missing BCVA Values of Weeks 40, 44 and 48. | 2.5 ETDRS Letters | Standard Error 0.78 |
| Aflibercept (Treatment Group B) | Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to the Average of Non-missing BCVA Values of Weeks 40, 44 and 48. | 4.6 ETDRS Letters | Standard Error 0.76 |
p-value: 0.008395.03% CI: [-3.88, -0.29]Mixed Models Analysis
Secondary
Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
Time frame: Day 1 to Week 48
Population: Full analysis set defined as all randomized subjects who received at least one treatment injection. Subjects will be analyzed according to their randomized treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KSI-301 (Treatment Group A) | Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Week 8 | 3.7 ETDRS Letters | Standard Deviation 8.52 |
| KSI-301 (Treatment Group A) | Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Week 28 | 4.5 ETDRS Letters | Standard Deviation 9.75 |
| KSI-301 (Treatment Group A) | Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Week 16 | 3.6 ETDRS Letters | Standard Deviation 9.09 |
| KSI-301 (Treatment Group A) | Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Week 32 | 3.9 ETDRS Letters | Standard Deviation 10.32 |
| KSI-301 (Treatment Group A) | Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Week 4 | 3.4 ETDRS Letters | Standard Deviation 7.05 |
| KSI-301 (Treatment Group A) | Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Week 36 | 3.7 ETDRS Letters | Standard Deviation 10.58 |
| KSI-301 (Treatment Group A) | Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Week 20 | 3.9 ETDRS Letters | Standard Deviation 9.6 |
| KSI-301 (Treatment Group A) | Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Week 40 | 4.0 ETDRS Letters | Standard Deviation 11.05 |
| KSI-301 (Treatment Group A) | Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Week 12 | 3.8 ETDRS Letters | Standard Deviation 8.83 |
| KSI-301 (Treatment Group A) | Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Week 44 | 4.7 ETDRS Letters | Standard Deviation 9.99 |
| KSI-301 (Treatment Group A) | Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Week 24 | 4.5 ETDRS Letters | Standard Deviation 9.29 |
| KSI-301 (Treatment Group A) | Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Week 48 | 3.7 ETDRS Letters | Standard Deviation 11.12 |
| KSI-301 (Treatment Group A) | Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Week 2 | 2.8 ETDRS Letters | Standard Deviation 6.48 |
| Aflibercept (Treatment Group B) | Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Week 48 | 5.4 ETDRS Letters | Standard Deviation 11.36 |
| Aflibercept (Treatment Group B) | Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Week 2 | 2.9 ETDRS Letters | Standard Deviation 7.12 |
| Aflibercept (Treatment Group B) | Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Week 4 | 4.2 ETDRS Letters | Standard Deviation 7.29 |
| Aflibercept (Treatment Group B) | Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Week 8 | 5.1 ETDRS Letters | Standard Deviation 7.86 |
| Aflibercept (Treatment Group B) | Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Week 12 | 5.4 ETDRS Letters | Standard Deviation 7.9 |
| Aflibercept (Treatment Group B) | Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Week 16 | 4.9 ETDRS Letters | Standard Deviation 8.54 |
| Aflibercept (Treatment Group B) | Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Week 20 | 5.7 ETDRS Letters | Standard Deviation 8.97 |
| Aflibercept (Treatment Group B) | Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Week 24 | 6.0 ETDRS Letters | Standard Deviation 9.45 |
| Aflibercept (Treatment Group B) | Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Week 28 | 6.1 ETDRS Letters | Standard Deviation 9.49 |
| Aflibercept (Treatment Group B) | Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Week 32 | 6.1 ETDRS Letters | Standard Deviation 9.86 |
| Aflibercept (Treatment Group B) | Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Week 36 | 6.1 ETDRS Letters | Standard Deviation 9.77 |
| Aflibercept (Treatment Group B) | Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Week 40 | 5.6 ETDRS Letters | Standard Deviation 10.75 |
| Aflibercept (Treatment Group B) | Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | Week 44 | 5.9 ETDRS Letters | Standard Deviation 10.71 |
Secondary
Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time
Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) as assessed by a central reading center.
Time frame: Day 1 to Week 48
Population: Full analysis set defined as all randomized subjects who received at least one treatment injection. Subjects will be analyzed according to their randomized treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KSI-301 (Treatment Group A) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Week 12 | -97.1 Microns | Standard Deviation 118.62 |
| KSI-301 (Treatment Group A) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Week 28 | -114.6 Microns | Standard Deviation 111.47 |
| KSI-301 (Treatment Group A) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Week 2 | -72.1 Microns | Standard Deviation 83.74 |
| KSI-301 (Treatment Group A) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Week 32 | -111.9 Microns | Standard Deviation 122.05 |
| KSI-301 (Treatment Group A) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Week 16 | -107.2 Microns | Standard Deviation 110.02 |
| KSI-301 (Treatment Group A) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Week 36 | -113.6 Microns | Standard Deviation 129.84 |
| KSI-301 (Treatment Group A) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Week 40 | -113.6 Microns | Standard Deviation 115.34 |
| KSI-301 (Treatment Group A) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Week 8 | -89.1 Microns | Standard Deviation 121.13 |
| KSI-301 (Treatment Group A) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Week 44 | -115.8 Microns | Standard Deviation 115.81 |
| KSI-301 (Treatment Group A) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Week 20 | -111 Microns | Standard Deviation 112.97 |
| KSI-301 (Treatment Group A) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Week 48 | -117 Microns | Standard Deviation 114 |
| KSI-301 (Treatment Group A) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Week 4 | -74.9 Microns | Standard Deviation 98.33 |
| KSI-301 (Treatment Group A) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Week 40-48 Average | -114.6 Microns | Standard Deviation 113.92 |
| KSI-301 (Treatment Group A) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Week 24 | -109.9 Microns | Standard Deviation 112.82 |
| Aflibercept (Treatment Group B) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Week 40-48 Average | -113.4 Microns | Standard Deviation 112.07 |
| Aflibercept (Treatment Group B) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Week 2 | -99.9 Microns | Standard Deviation 93.75 |
| Aflibercept (Treatment Group B) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Week 4 | -109.4 Microns | Standard Deviation 100.87 |
| Aflibercept (Treatment Group B) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Week 8 | -122.2 Microns | Standard Deviation 109.58 |
| Aflibercept (Treatment Group B) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Week 12 | -126.3 Microns | Standard Deviation 111.55 |
| Aflibercept (Treatment Group B) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Week 16 | -99.2 Microns | Standard Deviation 110.47 |
| Aflibercept (Treatment Group B) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Week 20 | -125.5 Microns | Standard Deviation 117.39 |
| Aflibercept (Treatment Group B) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Week 24 | -101.8 Microns | Standard Deviation 113.21 |
| Aflibercept (Treatment Group B) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Week 28 | -124.1 Microns | Standard Deviation 111.51 |
| Aflibercept (Treatment Group B) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Week 32 | -104.3 Microns | Standard Deviation 116.09 |
| Aflibercept (Treatment Group B) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Week 40 | -103.1 Microns | Standard Deviation 109.25 |
| Aflibercept (Treatment Group B) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Week 44 | -129.4 Microns | Standard Deviation 114.7 |
| Aflibercept (Treatment Group B) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Week 48 | -109.2 Microns | Standard Deviation 120.75 |
| Aflibercept (Treatment Group B) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | Week 36 | -124.4 Microns | Standard Deviation 112.12 |
Secondary
Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters)
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
Time frame: Day 1 to Week 48
Population: Full analysis set defined as all randomized subjects who received at least one treatment injection. Subjects will be analyzed according to their randomized treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| KSI-301 (Treatment Group A) | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Snellen Equivalent of 20/200 or Worse at Baseline | 17 Participants |
| KSI-301 (Treatment Group A) | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Snellen Equivalent of 20/200 or Worse at Week 2 | 11 Participants |
| KSI-301 (Treatment Group A) | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Snellen Equivalent of 20/200 or Worse at Week 4 | 10 Participants |
| KSI-301 (Treatment Group A) | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Snellen Equivalent of 20/200 or Worse at Week 8 | 11 Participants |
| KSI-301 (Treatment Group A) | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Snellen Equivalent of 20/200 or Worse at Week 12 | 11 Participants |
| KSI-301 (Treatment Group A) | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Snellen Equivalent of 20/200 or Worse at Week 16 | 11 Participants |
| KSI-301 (Treatment Group A) | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Snellen Equivalent of 20/200 or Worse at Week 20 | 13 Participants |
| KSI-301 (Treatment Group A) | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Snellen Equivalent of 20/200 or Worse at Week 24 | 11 Participants |
| KSI-301 (Treatment Group A) | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Snellen Equivalent of 20/200 or Worse at Week 28 | 12 Participants |
| KSI-301 (Treatment Group A) | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Snellen Equivalent of 20/200 or Worse at Week 32 | 14 Participants |
| KSI-301 (Treatment Group A) | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Snellen Equivalent of 20/200 or Worse at Week 36 | 14 Participants |
| KSI-301 (Treatment Group A) | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Snellen Equivalent of 20/200 or Worse at Week 40 | 14 Participants |
| KSI-301 (Treatment Group A) | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Snellen Equivalent of 20/200 or Worse at Week 44 | 9 Participants |
| KSI-301 (Treatment Group A) | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Snellen Equivalent of 20/200 or Worse at Week 48 | 15 Participants |
| Aflibercept (Treatment Group B) | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Snellen Equivalent of 20/200 or Worse at Week 36 | 13 Participants |
| Aflibercept (Treatment Group B) | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Snellen Equivalent of 20/200 or Worse at Baseline | 15 Participants |
| Aflibercept (Treatment Group B) | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Snellen Equivalent of 20/200 or Worse at Week 24 | 13 Participants |
| Aflibercept (Treatment Group B) | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Snellen Equivalent of 20/200 or Worse at Week 2 | 12 Participants |
| Aflibercept (Treatment Group B) | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Snellen Equivalent of 20/200 or Worse at Week 44 | 15 Participants |
| Aflibercept (Treatment Group B) | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Snellen Equivalent of 20/200 or Worse at Week 4 | 14 Participants |
| Aflibercept (Treatment Group B) | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Snellen Equivalent of 20/200 or Worse at Week 28 | 13 Participants |
| Aflibercept (Treatment Group B) | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Snellen Equivalent of 20/200 or Worse at Week 8 | 13 Participants |
| Aflibercept (Treatment Group B) | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Snellen Equivalent of 20/200 or Worse at Week 40 | 17 Participants |
| Aflibercept (Treatment Group B) | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Snellen Equivalent of 20/200 or Worse at Week 12 | 12 Participants |
| Aflibercept (Treatment Group B) | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Snellen Equivalent of 20/200 or Worse at Week 32 | 18 Participants |
| Aflibercept (Treatment Group B) | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Snellen Equivalent of 20/200 or Worse at Week 16 | 10 Participants |
| Aflibercept (Treatment Group B) | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Snellen Equivalent of 20/200 or Worse at Week 48 | 15 Participants |
| Aflibercept (Treatment Group B) | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters) | Snellen Equivalent of 20/200 or Worse at Week 20 | 13 Participants |
Secondary
Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters)
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
Time frame: Day 1 to Week 48
Population: Full analysis set defined as all randomized subjects who received at least one treatment injection. Subjects will be analyzed according to their randomized treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| KSI-301 (Treatment Group A) | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Snellen Equivalent of 20/40 or Better at Baseline | 122 Participants |
| KSI-301 (Treatment Group A) | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Snellen Equivalent of 20/40 or Better at Week 2 | 148 Participants |
| KSI-301 (Treatment Group A) | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Snellen Equivalent of 20/40 or Better at Week 4 | 156 Participants |
| KSI-301 (Treatment Group A) | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Snellen Equivalent of 20/40 or Better at Week 8 | 156 Participants |
| KSI-301 (Treatment Group A) | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Snellen Equivalent of 20/40 or Better at Week 12 | 148 Participants |
| KSI-301 (Treatment Group A) | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Snellen Equivalent of 20/40 or Better at Week 16 | 149 Participants |
| KSI-301 (Treatment Group A) | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Snellen Equivalent of 20/40 or Better at Week 20 | 151 Participants |
| KSI-301 (Treatment Group A) | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Snellen Equivalent of 20/40 or Better at Week 24 | 158 Participants |
| KSI-301 (Treatment Group A) | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Snellen Equivalent of 20/40 or Better at Week 28 | 151 Participants |
| KSI-301 (Treatment Group A) | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Snellen Equivalent of 20/40 or Better at Week 32 | 147 Participants |
| KSI-301 (Treatment Group A) | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Snellen Equivalent of 20/40 or Better at Week 36 | 147 Participants |
| KSI-301 (Treatment Group A) | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Snellen Equivalent of 20/40 or Better at Week 40 | 151 Participants |
| KSI-301 (Treatment Group A) | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Snellen Equivalent of 20/40 or Better at Week 44 | 149 Participants |
| KSI-301 (Treatment Group A) | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Snellen Equivalent of 20/40 or Better at Week 48 | 144 Participants |
| Aflibercept (Treatment Group B) | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Snellen Equivalent of 20/40 or Better at Week 36 | 179 Participants |
| Aflibercept (Treatment Group B) | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Snellen Equivalent of 20/40 or Better at Baseline | 129 Participants |
| Aflibercept (Treatment Group B) | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Snellen Equivalent of 20/40 or Better at Week 24 | 183 Participants |
| Aflibercept (Treatment Group B) | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Snellen Equivalent of 20/40 or Better at Week 2 | 152 Participants |
| Aflibercept (Treatment Group B) | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Snellen Equivalent of 20/40 or Better at Week 44 | 178 Participants |
| Aflibercept (Treatment Group B) | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Snellen Equivalent of 20/40 or Better at Week 4 | 165 Participants |
| Aflibercept (Treatment Group B) | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Snellen Equivalent of 20/40 or Better at Week 28 | 175 Participants |
| Aflibercept (Treatment Group B) | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Snellen Equivalent of 20/40 or Better at Week 8 | 165 Participants |
| Aflibercept (Treatment Group B) | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Snellen Equivalent of 20/40 or Better at Week 40 | 174 Participants |
| Aflibercept (Treatment Group B) | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Snellen Equivalent of 20/40 or Better at Week 12 | 171 Participants |
| Aflibercept (Treatment Group B) | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Snellen Equivalent of 20/40 or Better at Week 32 | 174 Participants |
| Aflibercept (Treatment Group B) | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Snellen Equivalent of 20/40 or Better at Week 16 | 172 Participants |
| Aflibercept (Treatment Group B) | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Snellen Equivalent of 20/40 or Better at Week 48 | 175 Participants |
| Aflibercept (Treatment Group B) | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) | Snellen Equivalent of 20/40 or Better at Week 20 | 179 Participants |
Secondary
Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time
Categorical improvements in Best Corrected Visual Acuity (BCVA) of clinically relevant BCVA measurements corresponding to 1, 2 and 3 lines of the ETDRS vision testing chart
Time frame: Day 1 to Week 48
Population: Full analysis set defined as all randomized subjects who received at least one treatment injection. Subjects will be analyzed according to their randomized treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥5 ETDRS Letters at Week 2 | 100 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥5 ETDRS Letters at Week 4 | 110 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥5 ETDRS Letters at Week 8 | 119 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥5 ETDRS Letters at Week 12 | 124 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥5 ETDRS Letters at Week 16 | 119 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥5 ETDRS Letters at Week 20 | 121 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥5 ETDRS Letters at Week 24 | 130 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥5 ETDRS Letters at Week 28 | 122 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥5 ETDRS Letters at Week 32 | 132 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥5 ETDRS Letters at Week 36 | 120 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥5 ETDRS Letters at Week 40 | 116 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥5 ETDRS Letters at Week 44 | 126 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥5 ETDRS Letters at Week 48 | 111 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥10 ETDRS Letters at Week 2 | 31 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥10 ETDRS Letters at Week 4 | 44 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥10 ETDRS Letters at Week 8 | 52 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥10 ETDRS Letters at Week 12 | 55 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥10 ETDRS Letters at Week 16 | 62 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥10 ETDRS Letters at Week 20 | 66 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥10 ETDRS Letters at Week 24 | 70 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥10 ETDRS Letters at Week 28 | 66 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥10 ETDRS Letters at Week 32 | 57 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥10 ETDRS Letters at Week 36 | 66 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥10 ETDRS Letters at Week 40 | 67 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥10 ETDRS Letters at Week 44 | 67 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥10 ETDRS Letters at Week 48 | 65 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥15 ETDRS Letters at Week 2 | 12 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥15 ETDRS Letters at Week 4 | 18 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥15 ETDRS Letters at Week 8 | 24 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥15 ETDRS Letters at Week 12 | 20 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥15 ETDRS Letters at Week 16 | 24 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥15 ETDRS Letters at Week 20 | 28 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥15 ETDRS Letters at Week 24 | 33 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥15 ETDRS Letters at Week 28 | 36 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥15 ETDRS Letters at Week 32 | 32 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥15 ETDRS Letters at Week 36 | 32 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥15 ETDRS Letters at Week 40 | 33 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥15 ETDRS Letters at Week 44 | 34 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥15 ETDRS Letters at Week 48 | 35 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥10 ETDRS Letters at Week 24 | 90 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥5 ETDRS Letters at Week 2 | 96 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥15 ETDRS Letters at Week 12 | 29 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥5 ETDRS Letters at Week 4 | 129 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥10 ETDRS Letters at Week 28 | 87 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥5 ETDRS Letters at Week 8 | 151 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥15 ETDRS Letters at Week 32 | 37 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥5 ETDRS Letters at Week 12 | 148 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥10 ETDRS Letters at Week 32 | 95 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥5 ETDRS Letters at Week 16 | 143 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥15 ETDRS Letters at Week 16 | 33 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥5 ETDRS Letters at Week 20 | 161 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥10 ETDRS Letters at Week 36 | 81 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥5 ETDRS Letters at Week 24 | 156 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥15 ETDRS Letters at Week 48 | 49 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥5 ETDRS Letters at Week 28 | 154 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥10 ETDRS Letters at Week 40 | 80 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥5 ETDRS Letters at Week 32 | 168 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥15 ETDRS Letters at Week 20 | 33 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥5 ETDRS Letters at Week 36 | 158 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥10 ETDRS Letters at Week 44 | 86 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥5 ETDRS Letters at Week 40 | 156 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥15 ETDRS Letters at Week 36 | 44 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥5 ETDRS Letters at Week 44 | 151 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥10 ETDRS Letters at Week 48 | 85 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥5 ETDRS Letters at Week 48 | 150 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥15 ETDRS Letters at Week 24 | 42 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥10 ETDRS Letters at Week 2 | 37 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥15 ETDRS Letters at Week 2 | 11 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥10 ETDRS Letters at Week 4 | 54 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥15 ETDRS Letters at Week 44 | 48 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥10 ETDRS Letters at Week 8 | 72 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥15 ETDRS Letters at Week 4 | 21 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥10 ETDRS Letters at Week 12 | 72 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥15 ETDRS Letters at Week 28 | 46 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥10 ETDRS Letters at Week 16 | 68 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥15 ETDRS Letters at Week 8 | 28 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥10 ETDRS Letters at Week 20 | 86 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Gain ≥15 ETDRS Letters at Week 40 | 45 Participants |
Secondary
Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time
Categorical worsening in Best Corrected Visual Acuity (BCVA) of clinically relevant BCVA measurements corresponding to 1, 2 and 3 lines of the ETDRS vision testing chart
Time frame: Day 1 to Week 48
Population: Full analysis set defined as all randomized subjects who received at least one treatment injection. Subjects will be analyzed according to their randomized treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 5 ETDRS Letters at Week 2 | 20 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 5 ETDRS Letters at Week 4 | 27 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 5 ETDRS Letters at Week 8 | 41 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 5 ETDRS Letters at Week 12 | 35 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 5 ETDRS Letters at Week 16 | 35 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 5 ETDRS Letters at Week 20 | 35 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 5 ETDRS Letters at Week 24 | 34 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 5 ETDRS Letters at Week 28 | 38 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 5 ETDRS Letters at Week 32 | 41 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 5 ETDRS Letters at Week 36 | 47 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 5 ETDRS Letters at Week 40 | 33 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 5 ETDRS Letters at Week 44 | 33 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 5 ETDRS Letters at Week 48 | 39 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 10 ETDRS Letters at Week 2 | 6 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 10 ETDRS Letters at Week 4 | 6 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 10 ETDRS Letters at Week 8 | 10 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 10 ETDRS Letters at Week 12 | 15 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 10 ETDRS Letters at Week 16 | 15 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 10 ETDRS Letters at Week 20 | 16 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 10 ETDRS Letters at Week 24 | 17 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 10 ETDRS Letters at Week 28 | 21 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 10 ETDRS Letters at Week 32 | 23 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 10 ETDRS Letters at Week 36 | 22 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 10 ETDRS Letters at Week 40 | 21 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 10 ETDRS Letters at Week 44 | 18 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 10 ETDRS Letters at Week 48 | 24 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 15 ETDRS Letters at Week 2 | 3 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 15 ETDRS Letters at Week 4 | 4 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 15 ETDRS Letters at Week 8 | 4 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 15 ETDRS Letters at Week 12 | 6 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 15 ETDRS Letters at Week 16 | 9 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 15 ETDRS Letters at Week 20 | 7 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 15 ETDRS Letters at Week 24 | 7 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 15 ETDRS Letters at Week 28 | 7 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 15 ETDRS Letters at Week 32 | 10 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 15 ETDRS Letters at Week 36 | 14 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 15 ETDRS Letters at Week 40 | 18 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 15 ETDRS Letters at Week 44 | 8 Participants |
| KSI-301 (Treatment Group A) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 15 ETDRS Letters at Week 48 | 15 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 10 ETDRS Letters at Week 24 | 12 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 5 ETDRS Letters at Week 2 | 28 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 15 ETDRS Letters at Week 12 | 3 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 5 ETDRS Letters at Week 4 | 19 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 10 ETDRS Letters at Week 28 | 14 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 5 ETDRS Letters at Week 8 | 22 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 15 ETDRS Letters at Week 32 | 9 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 5 ETDRS Letters at Week 12 | 24 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 10 ETDRS Letters at Week 32 | 16 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 5 ETDRS Letters at Week 16 | 31 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 15 ETDRS Letters at Week 16 | 5 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 5 ETDRS Letters at Week 20 | 27 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 10 ETDRS Letters at Week 36 | 18 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 5 ETDRS Letters at Week 24 | 31 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 15 ETDRS Letters at Week 48 | 13 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 5 ETDRS Letters at Week 28 | 31 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 10 ETDRS Letters at Week 40 | 24 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 5 ETDRS Letters at Week 32 | 35 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 15 ETDRS Letters at Week 20 | 6 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 5 ETDRS Letters at Week 36 | 32 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 10 ETDRS Letters at Week 44 | 21 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 5 ETDRS Letters at Week 40 | 41 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 15 ETDRS Letters at Week 36 | 9 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 5 ETDRS Letters at Week 44 | 33 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 10 ETDRS Letters at Week 48 | 25 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 5 ETDRS Letters at Week 48 | 38 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 15 ETDRS Letters at Week 24 | 6 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 10 ETDRS Letters at Week 2 | 10 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 15 ETDRS Letters at Week 2 | 4 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 10 ETDRS Letters at Week 4 | 4 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 15 ETDRS Letters at Week 44 | 11 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 10 ETDRS Letters at Week 8 | 8 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 15 ETDRS Letters at Week 4 | 4 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 10 ETDRS Letters at Week 12 | 9 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 15 ETDRS Letters at Week 28 | 5 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 10 ETDRS Letters at Week 16 | 15 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 15 ETDRS Letters at Week 8 | 4 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 10 ETDRS Letters at Week 20 | 14 Participants |
| Aflibercept (Treatment Group B) | Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time | Loss ≥ 15 ETDRS Letters at Week 40 | 13 Participants |