Branch Retinal Vein Occlusion
Conditions
Keywords
Macular Edema, Branch Retinal Vein Occlusion, visual impairment
Brief summary
This study will generate comparative data for 0.5-mg ranibizumab using PRN dosing administered with or without adjunctive laser treatment versus laser photocoagulation (the current standard of care) up to Month 6 in patients with visual impairment due to ME secondary to BRVO. Additionally the results of this study will provide long-term (24-month) safety and efficacy data for ranibizumab, administered with or without adjunctive laser treatment in this indication.
Interventions
DRUGRanibizumab
PROCEDURELaser
laser photocoagulation
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent must be obtained before any study assessment is performed * Diagnosis of visual impairment exclusively due to ME secondary to BRVO * BCVA score at Screening and Baseline between 73 and 19 letters (ETDRS)
Exclusion criteria
* Pregnant or nursing (lactating) women * Stroke or myocardial infarction less than 3 months before Screening * Uncontrolled blood pressure defined as systolic value of \>160 mm Hg or diastolic value of \>100 mm Hg at Screening or Baseline. * Any active periocular or ocular infection or inflammation at Screening or Baseline in either eye * Uncontrolled glaucoma at Screening or Baseline or diagnosed within 6 months before Baseline in either eye * Neovascularization of the iris or neovascular glaucoma in the study eye * Use of any systemic antivascular endothelial growth factor (anti-VEGF) drugs within 6 months before Baseline * Panretinal laser photocoagulation within 3 months before Baseline or anticipated or scheduled within the next 3 months following Baseline in the study eye * Focal or grid laser photocoagulation within 4 months before Baseline in the study eye * Use of intra- or periocular corticosteroids (including sub-Tenon) within 3 months before Screening in the study eye * Any use of intraocular corticosteroid implants (eg, dexamethasone \[Ozurdex®\], fluocinolone acetonide \[Iluvien®\]) in the study eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) | Baseline, 6 Months | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 6 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and assessed by an ANOVA model. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Ranibizumab Treatments From Day 1 to Month 23 by Treatment Group | Day 1 through Month 23 | Number of injections provided to the patients during the 23 month period and conducted within FAS with LOCF and observed data. |
| Mean Average Change in Visual Acuity (BCVA Letters) From Month 1 Through Month 6 | From Baseline through Month 6 | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters.(A positive average change from baseline of BCVA indicates improvement): Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 6. Then, mean average change is calculated as the average of average changes across all patients. |
| The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24 | Baseline, Month 12 and Month 24 | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 12 and Month 24 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and were assessed by an ANOVA model. |
| The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | Baseline, Month 6 and Month 24 | BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters of visual acuity at Month 6 & Month 24 as compared with baseline, was assessed by an ANOVA model. Endpoints related to the proportion of patients with BCVA letter gain or loss from Baseline was analyzed via stratified Cochran-Mantel-Haenszel test with stratification based on baseline BCVA (baseline BCVA less than or equal to 39, 40 to 59, greater than or equal to 60 letters, treatment groups). |
| The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline | Baseline, 24 Months | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. (A positive average change from baseline of BCVA indicates improvement): Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 24. Then, mean average change is calculated as the average of average changes across all patients. |
| Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye | Month 24 | Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and Month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 24 indicates a positive outcome. |
| The Mean Change in Central Reading Center-assessed Central Subfield Thickness From Month 12 and Month 24 vs. Baseline by Treatment Arm | Month 12 and Month 24 | Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation. Stratification was done based on categories of baseline best corrected visual acuity & analysis was based on analysis of variance (ANOVA) |
| The Mean Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 6 and Month 24 Compared to Baseline | Months 6 and 24 | The survey consists of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. In this format scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score. |
| BCVA (Letters) Mean Average Change From First Ranibizumab Treatment to Month 24 in the Study Eye for Patients Randomized to the Laser Monotherapy Arm | Month 24 | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 24 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and assessed by an ANOVA model. |
| Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye | Month 6 | Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and Month 6 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 6 indicates a positive outcome. |
Countries
Australia, Canada, Czechia, Denmark, France, Greece, Hungary, Ireland, Italy, Netherlands, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1-ranibizumab Monotherapy laser therapy + Ranibizumab 0.5 mg | 183 |
| 2-ranibizumab With Laser Ranibizumab 0.5 mg + laser | 180 |
| 3-laser Monotherapy after 6 months, laser patients could be treated with ranibizumab | 92 |
| Total | 455 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative issue | 1 | 0 | 1 |
| Overall Study | Adverse Event | 3 | 8 | 4 |
| Overall Study | Death | 2 | 1 | 2 |
| Overall Study | Lost to Follow-up | 3 | 3 | 3 |
| Overall Study | Physician Decision | 2 | 0 | 7 |
| Overall Study | Protocol Violation | 0 | 3 | 0 |
| Overall Study | Withdrawal by Subject | 11 | 11 | 10 |
Baseline characteristics
| Characteristic | 1-ranibizumab Monotherapy | 2-ranibizumab With Laser | 3-laser Monotherapy | Total |
|---|---|---|---|---|
| Age, Continuous | 64.7 years STANDARD_DEVIATION 10.34 | 67.3 years STANDARD_DEVIATION 10.41 | 67.7 years STANDARD_DEVIATION 9.67 | 66.3 years STANDARD_DEVIATION 10.3 |
| Sex: Female, Male Female | 90 Participants | 84 Participants | 55 Participants | 229 Participants |
| Sex: Female, Male Male | 93 Participants | 96 Participants | 37 Participants | 226 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 112 / 180 | 121 / 183 | 40 / 63 | 14 / 25 |
| serious Total, serious adverse events | 30 / 180 | 33 / 183 | 10 / 63 | 3 / 25 |
Outcome results
Primary
Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO)
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 6 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and assessed by an ANOVA model.
Time frame: Baseline, 6 Months
Population: analysis for change consists of the group that had a baseline and 6 month data point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1-ranibizumab Monotherapy | Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) | Change from Baseline atMonth 6 | 14.8 letters | Standard Deviation 10.7 |
| 1-ranibizumab Monotherapy | Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) | Baseline | 59.5 letters | Standard Deviation 11.78 |
| 1-ranibizumab Monotherapy | Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) | Month 6 | 74.3 letters | Standard Deviation 12.27 |
| 2-ranibizumab With Laser | Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) | Month 6 | 71.4 letters | Standard Deviation 14.43 |
| 2-ranibizumab With Laser | Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) | Change from Baseline atMonth 6 | 14.8 letters | Standard Deviation 11.13 |
| 2-ranibizumab With Laser | Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) | Baseline | 56.6 letters | Standard Deviation 13.19 |
| 3-laser Monotherapy | Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) | Baseline | 56.8 letters | Standard Deviation 13.86 |
| 3-laser Monotherapy | Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) | Change from Baseline atMonth 6 | 6.0 letters | Standard Deviation 14.27 |
| 3-laser Monotherapy | Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) | Month 6 | 62.8 letters | Standard Deviation 14.08 |
p-value: <0.000195% CI: [7.3, 12.8]ANOVA
p-value: <0.000195% CI: [5.8, 11.6]ANOVA
Secondary
BCVA (Letters) Mean Average Change From First Ranibizumab Treatment to Month 24 in the Study Eye for Patients Randomized to the Laser Monotherapy Arm
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 24 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and assessed by an ANOVA model.
Time frame: Month 24
Population: Randomized set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1-ranibizumab Monotherapy | BCVA (Letters) Mean Average Change From First Ranibizumab Treatment to Month 24 in the Study Eye for Patients Randomized to the Laser Monotherapy Arm | Value at 1st Ranibizumab treatment | 61.7 BCVA letters | Standard Deviation 12.21 |
| 1-ranibizumab Monotherapy | BCVA (Letters) Mean Average Change From First Ranibizumab Treatment to Month 24 in the Study Eye for Patients Randomized to the Laser Monotherapy Arm | Average post 1st treatment through Month 24 | 68.16 BCVA letters | Standard Deviation 11.84 |
| 1-ranibizumab Monotherapy | BCVA (Letters) Mean Average Change From First Ranibizumab Treatment to Month 24 in the Study Eye for Patients Randomized to the Laser Monotherapy Arm | Change from 1st Ranibizumab treatment | 6.49 BCVA letters | Standard Deviation 7.83 |
Secondary
Mean Average Change in Visual Acuity (BCVA Letters) From Month 1 Through Month 6
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters.(A positive average change from baseline of BCVA indicates improvement): Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 6. Then, mean average change is calculated as the average of average changes across all patients.
Time frame: From Baseline through Month 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1-ranibizumab Monotherapy | Mean Average Change in Visual Acuity (BCVA Letters) From Month 1 Through Month 6 | Change from Baseline | 13.2 letters | Standard Deviation 9.6 |
| 1-ranibizumab Monotherapy | Mean Average Change in Visual Acuity (BCVA Letters) From Month 1 Through Month 6 | Baseline | 59.5 letters | Standard Deviation 11.78 |
| 1-ranibizumab Monotherapy | Mean Average Change in Visual Acuity (BCVA Letters) From Month 1 Through Month 6 | Average Month 1 to Month 6 | 72.7 letters | Standard Deviation 11.49 |
| 2-ranibizumab With Laser | Mean Average Change in Visual Acuity (BCVA Letters) From Month 1 Through Month 6 | Change from Baseline | 13.2 letters | Standard Deviation 9.89 |
| 2-ranibizumab With Laser | Mean Average Change in Visual Acuity (BCVA Letters) From Month 1 Through Month 6 | Baseline | 56.6 letters | Standard Deviation 13.19 |
| 2-ranibizumab With Laser | Mean Average Change in Visual Acuity (BCVA Letters) From Month 1 Through Month 6 | Average Month 1 to Month 6 | 69.7 letters | Standard Deviation 13.38 |
| 3-laser Monotherapy | Mean Average Change in Visual Acuity (BCVA Letters) From Month 1 Through Month 6 | Change from Baseline | 4.8 letters | Standard Deviation 11.69 |
| 3-laser Monotherapy | Mean Average Change in Visual Acuity (BCVA Letters) From Month 1 Through Month 6 | Baseline | 56.8 letters | Standard Deviation 13.86 |
| 3-laser Monotherapy | Mean Average Change in Visual Acuity (BCVA Letters) From Month 1 Through Month 6 | Average Month 1 to Month 6 | 61.7 letters | Standard Deviation 12.66 |
Secondary
Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye
Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and Month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 24 indicates a positive outcome.
Time frame: Month 24
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1-ranibizumab Monotherapy | Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye | BCVA improvement of ≥ 1 letter | 161 participants |
| 1-ranibizumab Monotherapy | Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye | BCVA improvement of ≥ 5 letters | 150 participants |
| 1-ranibizumab Monotherapy | Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye | BCVA improvement of ≥ 10 letters | 129 participants |
| 1-ranibizumab Monotherapy | Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye | BCVA improvement of ≥ 15 letters | 95 participants |
| 1-ranibizumab Monotherapy | Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye | BCVA improvement of ≥ 30 letters | 24 participants |
| 1-ranibizumab Monotherapy | Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye | BCVA score ≥ 73 letters | 119 participants |
| 2-ranibizumab With Laser | Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye | BCVA score ≥ 73 letters | 114 participants |
| 2-ranibizumab With Laser | Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye | BCVA improvement of ≥ 1 letter | 167 participants |
| 2-ranibizumab With Laser | Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye | BCVA improvement of ≥ 15 letters | 106 participants |
| 2-ranibizumab With Laser | Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye | BCVA improvement of ≥ 30 letters | 25 participants |
| 2-ranibizumab With Laser | Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye | BCVA improvement of ≥ 5 letters | 159 participants |
| 2-ranibizumab With Laser | Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye | BCVA improvement of ≥ 10 letters | 135 participants |
| 3-laser Monotherapy | Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye | BCVA improvement of ≥ 5 letters | 63 participants |
| 3-laser Monotherapy | Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye | BCVA improvement of ≥ 10 letters | 54 participants |
| 3-laser Monotherapy | Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye | BCVA score ≥ 73 letters | 41 participants |
| 3-laser Monotherapy | Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye | BCVA improvement of ≥ 15 letters | 39 participants |
| 3-laser Monotherapy | Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye | BCVA improvement of ≥ 1 letter | 70 participants |
| 3-laser Monotherapy | Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye | BCVA improvement of ≥ 30 letters | 10 participants |
Secondary
Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye
Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and Month 6 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 6 indicates a positive outcome.
Time frame: Month 6
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1-ranibizumab Monotherapy | Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye | BCVA improvement of ≥ 1 letter | 168 participants |
| 1-ranibizumab Monotherapy | Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye | BCVA improvement of ≥ 5 letters N | 155 participants |
| 1-ranibizumab Monotherapy | Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye | BCVA improvement of ≥ 10 letters | 120 participants |
| 1-ranibizumab Monotherapy | Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye | BCVA improvement of ≥ 15 letters | 81 participants |
| 1-ranibizumab Monotherapy | Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye | BCVA improvement of ≥ 30 letters | 18 participants |
| 1-ranibizumab Monotherapy | Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye | BCVA score ≥ 73 letters | 118 participants |
| 2-ranibizumab With Laser | Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye | BCVA score ≥ 73 letters | 97 participants |
| 2-ranibizumab With Laser | Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye | BCVA improvement of ≥ 1 letter | 171 participants |
| 2-ranibizumab With Laser | Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye | BCVA improvement of ≥ 15 letters | 84 participants |
| 2-ranibizumab With Laser | Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye | BCVA improvement of ≥ 30 letters | 17 participants |
| 2-ranibizumab With Laser | Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye | BCVA improvement of ≥ 5 letters N | 157 participants |
| 2-ranibizumab With Laser | Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye | BCVA improvement of ≥ 10 letters | 122 participants |
| 3-laser Monotherapy | Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye | BCVA improvement of ≥ 5 letters N | 45 participants |
| 3-laser Monotherapy | Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye | BCVA improvement of ≥ 10 letters | 37 participants |
| 3-laser Monotherapy | Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye | BCVA score ≥ 73 letters | 28 participants |
| 3-laser Monotherapy | Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye | BCVA improvement of ≥ 15 letters | 25 participants |
| 3-laser Monotherapy | Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye | BCVA improvement of ≥ 1 letter | 57 participants |
| 3-laser Monotherapy | Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye | BCVA improvement of ≥ 30 letters | 3 participants |
Secondary
Number of Ranibizumab Treatments From Day 1 to Month 23 by Treatment Group
Number of injections provided to the patients during the 23 month period and conducted within FAS with LOCF and observed data.
Time frame: Day 1 through Month 23
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1-ranibizumab Monotherapy | Number of Ranibizumab Treatments From Day 1 to Month 23 by Treatment Group | 11.4 treatments | Standard Deviation 5.76 |
| 2-ranibizumab With Laser | Number of Ranibizumab Treatments From Day 1 to Month 23 by Treatment Group | 11.3 treatments | Standard Deviation 6.03 |
Secondary
The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. (A positive average change from baseline of BCVA indicates improvement): Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 24. Then, mean average change is calculated as the average of average changes across all patients.
Time frame: Baseline, 24 Months
Population: analysis for change consists of the group that had a baseline and 24 month data point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1-ranibizumab Monotherapy | The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline | Average Month 1 toMonth 24 | 74.5 letters | Standard Deviation 12.11 |
| 1-ranibizumab Monotherapy | The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline | Baseline | 59.5 letters | Standard Deviation 11.78 |
| 1-ranibizumab Monotherapy | The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline | Change from Baseline | 15.0 letters | Standard Deviation 10.86 |
| 2-ranibizumab With Laser | The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline | Average Month 1 toMonth 24 | 72.0 letters | Standard Deviation 13.56 |
| 2-ranibizumab With Laser | The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline | Baseline | 56.6 letters | Standard Deviation 13.19 |
| 2-ranibizumab With Laser | The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline | Change from Baseline | 15.4 letters | Standard Deviation 10.76 |
| 3-laser Monotherapy | The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline | Baseline | 56.8 letters | Standard Deviation 13.86 |
| 3-laser Monotherapy | The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline | Change from Baseline | 9.1 letters | Standard Deviation 13.49 |
| 3-laser Monotherapy | The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline | Average Month 1 toMonth 24 | 65.9 letters | Standard Deviation 13.24 |
Secondary
The Mean Change in Central Reading Center-assessed Central Subfield Thickness From Month 12 and Month 24 vs. Baseline by Treatment Arm
Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation. Stratification was done based on categories of baseline best corrected visual acuity & analysis was based on analysis of variance (ANOVA)
Time frame: Month 12 and Month 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1-ranibizumab Monotherapy | The Mean Change in Central Reading Center-assessed Central Subfield Thickness From Month 12 and Month 24 vs. Baseline by Treatment Arm | month 12 | -215.9 microns | Standard Error 12.83 |
| 1-ranibizumab Monotherapy | The Mean Change in Central Reading Center-assessed Central Subfield Thickness From Month 12 and Month 24 vs. Baseline by Treatment Arm | month 24 | -228.1 microns | Standard Error 12.65 |
| 2-ranibizumab With Laser | The Mean Change in Central Reading Center-assessed Central Subfield Thickness From Month 12 and Month 24 vs. Baseline by Treatment Arm | month 24 | -261.7 microns | Standard Error 15.2 |
| 2-ranibizumab With Laser | The Mean Change in Central Reading Center-assessed Central Subfield Thickness From Month 12 and Month 24 vs. Baseline by Treatment Arm | month 12 | -242.5 microns | Standard Error 14.14 |
| 3-laser Monotherapy | The Mean Change in Central Reading Center-assessed Central Subfield Thickness From Month 12 and Month 24 vs. Baseline by Treatment Arm | month 24 | -232.7 microns | Standard Error 24.38 |
| 3-laser Monotherapy | The Mean Change in Central Reading Center-assessed Central Subfield Thickness From Month 12 and Month 24 vs. Baseline by Treatment Arm | month 12 | -203.9 microns | Standard Error 22.22 |
Secondary
The Mean Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 6 and Month 24 Compared to Baseline
The survey consists of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. In this format scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score.
Time frame: Months 6 and 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1-ranibizumab Monotherapy | The Mean Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 6 and Month 24 Compared to Baseline | month 6 composite score | 5.6 score on a scale | Standard Deviation 9.56 |
| 1-ranibizumab Monotherapy | The Mean Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 6 and Month 24 Compared to Baseline | month 24 composite score | 8.0 score on a scale | Standard Deviation 11.78 |
| 2-ranibizumab With Laser | The Mean Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 6 and Month 24 Compared to Baseline | month 6 composite score | 4.2 score on a scale | Standard Deviation 10.41 |
| 2-ranibizumab With Laser | The Mean Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 6 and Month 24 Compared to Baseline | month 24 composite score | 5.0 score on a scale | Standard Deviation 11.44 |
| 3-laser Monotherapy | The Mean Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 6 and Month 24 Compared to Baseline | month 6 composite score | 3.7 score on a scale | Standard Deviation 12.12 |
| 3-laser Monotherapy | The Mean Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 6 and Month 24 Compared to Baseline | month 24 composite score | 4.9 score on a scale | Standard Deviation 14.79 |
Secondary
The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 12 and Month 24 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and were assessed by an ANOVA model.
Time frame: Baseline, Month 12 and Month 24
Population: Full Analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1-ranibizumab Monotherapy | The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24 | Month 24 | 75.0 letters | Standard Deviation 14.65 |
| 1-ranibizumab Monotherapy | The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24 | Change from baseline Month 12 | 15.4 letters | Standard Deviation 12.25 |
| 1-ranibizumab Monotherapy | The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24 | Month 12 | 74.9 letters | Standard Deviation 12.87 |
| 1-ranibizumab Monotherapy | The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24 | Change from baseline Month 24 | 15.5 letters | Standard Deviation 13.91 |
| 1-ranibizumab Monotherapy | The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24 | Baseline | 59.5 letters | Standard Deviation 11.78 |
| 2-ranibizumab With Laser | The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24 | Change from baseline Month 12 | 15.7 letters | Standard Deviation 13.12 |
| 2-ranibizumab With Laser | The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24 | Baseline | 56.6 letters | Standard Deviation 13.19 |
| 2-ranibizumab With Laser | The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24 | Month 12 | 72.3 letters | Standard Deviation 15.31 |
| 2-ranibizumab With Laser | The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24 | Month 24 | 73.9 letters | Standard Deviation 14.59 |
| 2-ranibizumab With Laser | The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24 | Change from baseline Month 24 | 17.3 letters | Standard Deviation 12.61 |
| 3-laser Monotherapy | The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24 | Change from baseline Month 24 | 11.6 letters | Standard Deviation 16.09 |
| 3-laser Monotherapy | The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24 | Month 24 | 68.4 letters | Standard Deviation 15.26 |
| 3-laser Monotherapy | The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24 | Baseline | 56.8 letters | Standard Deviation 13.86 |
| 3-laser Monotherapy | The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24 | Change from baseline Month 12 | 10.0 letters | Standard Deviation 14.33 |
| 3-laser Monotherapy | The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24 | Month 12 | 66.8 letters | Standard Deviation 13.87 |
Secondary
The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit
BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters of visual acuity at Month 6 & Month 24 as compared with baseline, was assessed by an ANOVA model. Endpoints related to the proportion of patients with BCVA letter gain or loss from Baseline was analyzed via stratified Cochran-Mantel-Haenszel test with stratification based on baseline BCVA (baseline BCVA less than or equal to 39, 40 to 59, greater than or equal to 60 letters, treatment groups).
Time frame: Baseline, Month 6 and Month 24
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1-ranibizumab Monotherapy | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 5 lettersmonth 24 | 83.3 percent patients gaining improvement |
| 1-ranibizumab Monotherapy | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 15 lettersmonth 24 | 52.8 percent patients gaining improvement |
| 1-ranibizumab Monotherapy | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 1 lettermonth 24 | 89.4 percent patients gaining improvement |
| 1-ranibizumab Monotherapy | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 10 lettersmonth 6 | 66.7 percent patients gaining improvement |
| 1-ranibizumab Monotherapy | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 5 lettersmonth 6 | 86.1 percent patients gaining improvement |
| 1-ranibizumab Monotherapy | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 30 lettersmonth 24 | 13.3 percent patients gaining improvement |
| 1-ranibizumab Monotherapy | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 10 lettersmonth 24 | 71.1 percent patients gaining improvement |
| 1-ranibizumab Monotherapy | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 30 lettersmonth 6 | 10.0 percent patients gaining improvement |
| 1-ranibizumab Monotherapy | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 15 lettersmonth 6 | 45.0 percent patients gaining improvement |
| 1-ranibizumab Monotherapy | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 1 lettermonth 6 | 93.3 percent patients gaining improvement |
| 2-ranibizumab With Laser | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 15 lettersmonth 6 | 47.2 percent patients gaining improvement |
| 2-ranibizumab With Laser | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 15 lettersmonth 24 | 59.6 percent patients gaining improvement |
| 2-ranibizumab With Laser | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 30 lettersmonth 6 | 9.6 percent patients gaining improvement |
| 2-ranibizumab With Laser | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 5 lettersmonth 6 | 88.2 percent patients gaining improvement |
| 2-ranibizumab With Laser | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 30 lettersmonth 24 | 14.0 percent patients gaining improvement |
| 2-ranibizumab With Laser | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 5 lettersmonth 24 | 89.3 percent patients gaining improvement |
| 2-ranibizumab With Laser | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 10 lettersmonth 6 | 68.5 percent patients gaining improvement |
| 2-ranibizumab With Laser | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 1 lettermonth 24 | 93.8 percent patients gaining improvement |
| 2-ranibizumab With Laser | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 10 lettersmonth 24 | 75.8 percent patients gaining improvement |
| 2-ranibizumab With Laser | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 1 lettermonth 6 | 96.1 percent patients gaining improvement |
| 3-laser Monotherapy | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 30 lettersmonth 24 | 11.1 percent patients gaining improvement |
| 3-laser Monotherapy | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 1 lettermonth 6 | 63.3 percent patients gaining improvement |
| 3-laser Monotherapy | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 1 lettermonth 24 | 77.8 percent patients gaining improvement |
| 3-laser Monotherapy | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 5 lettersmonth 6 | 50.0 percent patients gaining improvement |
| 3-laser Monotherapy | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 5 lettersmonth 24 | 70.0 percent patients gaining improvement |
| 3-laser Monotherapy | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 10 lettersmonth 6 | 41.1 percent patients gaining improvement |
| 3-laser Monotherapy | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 15 lettersmonth 6 | 27.8 percent patients gaining improvement |
| 3-laser Monotherapy | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 15 lettersmonth 24 | 43.3 percent patients gaining improvement |
| 3-laser Monotherapy | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 30 lettersmonth 6 | 3.3 percent patients gaining improvement |
| 3-laser Monotherapy | The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit | BCVA improvement of >= 10 lettersmonth 24 | 60.0 percent patients gaining improvement |