Choroidal Neovascularization (CNV)
Conditions
Keywords
Vision Impairment, Abnormal growth of blood vessels
Brief summary
This study was conducted to evaluate the efficacy and safety of 0.5 mg ranibizumab in adult and adolescent patients with visual impairment due to choridal neovascularization (CNV).
Interventions
DRUGRanibizumab
Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.
OTHERSham control
The sham vial did not contain active drug (empty sterile vial). The sham injection was an imitation of an intravitreal injection using an injection syringe without a needle touching the eye.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Diagnosis of active CNV secondary to any causes with the CNV or its sequelae affecting the fovea; * BCVA must be between ≥ 24 and ≤ 83 letters in the study eye; * Visual loss in the study eye should mainly be due to the presence of any eligible types of CNV; Key
Exclusion criteria
* Women of child-bearing potential; * Active malignancies; * History of stroke less than 6 months prior to screening; * Uncontrolled systemic inflammation or infection; * Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation; * CNV- conditions with a high likelihood of spontaneous resolution; * History of intravitreal treatment with steroids; * History of laser photocoagulation; * History of intraocular treatment with any anti-angiogenic drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2 | Baseline, Month 2 | BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. The data were analyzed using mixed model repeated measures (MMRM) which contained scheduled visit, the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate and treatment group by visit and visit by centered baseline BCVA interactions. A positive change from baseline indicated improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | CSFT was assessed by optical coherence tomography (OCT). A negative change from baseline indicates improvement. |
| Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | CSFV was assessed OCT. A negative change from baseline indicates improvement. |
| Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline | Baseline, Month 2, Month 6, Month 12 | The presence of intra-retinal fluid was assessed by OCT. |
| Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline | Baseline, Month 2, Month 6, Month 12 | Presence of subretinal fluid in study eye compared to baseline |
| Number of Participants With Presence of Active Chorioretinal Leakage | Baseline, Month 2, Month 6, Month 12 | The presence of active chorioretinal leakage was assessed by photography imaging, i.e. fluorescein angiography (FA). |
| Average Change From Baseline in BCVA | Baseline (BL), Month 1 through Month 6, Month 1 through Month 12 | BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. BCVA was assessed at each month from Month 1 through Month 6 or at each month from Month 1 through month 12, and the data were averaged. The outcome measure is reporting the change between baseline and average BCVA from Month 1 through Month 6 or from Month 1 through Month 12 (average BCVA - baseline BCVA). A positive change from baseline indicated improvement. |
| Change From Baseline in BCVA in Study Eye up to Month 2 | Baseline, Month 1, Month 2 | BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. The data were analyzed using analysis of covariance (ANCOVA) model which contained the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate. A positive change from baseline indicated improvement. |
| Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 2, Month 6, Month 12 | VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters. |
| Number of Participants With Requirement for Rescue Treatment at Month 1 | Month 1 | Rescue treatment with laser photocoagulation or periocular treatment could be administered at Month 1 only if the participant had a visual acuity loss of \> 5 letters due to disease activity from baseline to Month 1. |
| Number of Participants With Ranibizumab Treatments in Study Eye | Month 12 | The number of participants administered study treatments, according to treatment frequency, was assessed. |
| Number of Participants With Re-treatments | Month 12 | The number of participants, administered re-treatments according to treatment frequency, was assessed. Re-treatment was defined as an administration of study medication following at least one non-missed visit where treatment was not administered in the study eye. Up to month 12, the maximum number of retreatments was 5. |
| Number of Primary Reasons for Decision to Treat by Investigator | Month 12 | The total number of primary reasons for decisions to treat was assessed. A single participant could have had multiple primary reasons for treatment. |
| Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 2, Month 6, Month 12 | VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters. |
Countries
Australia, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Peru, Poland, Portugal, Russia, Singapore, Slovakia, South Korea, Spain, Switzerland, Turkey (Türkiye)
Participant flow
Pre-assignment details
A total of 183 participants were enrolled. Of these, 178 adults were randomized in a 2:1 ratio and considered for analysis. There were 5 adolescent participants, non-randomized, who received open-label treatment and were not included in the analyses. Therefore, the number enrolled = 183 differs from the participant flow number started = 178.
Participants by arm
| Arm | Count |
|---|---|
| Ranibizumab A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity. | 119 |
| Sham Control Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis. | 59 |
| Total | 178 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Physician Decision | 1 | 2 |
| Overall Study | Pregnancy | 1 | 0 |
| Overall Study | Protocol deviation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Ranibizumab | Sham Control | Total |
|---|---|---|---|
| Age, Continuous | 54.6 Years STANDARD_DEVIATION 15.07 | 51.9 Years STANDARD_DEVIATION 17.29 | 53.7 Years STANDARD_DEVIATION 15.85 |
| Sex: Female, Male Female | 60 Participants | 30 Participants | 90 Participants |
| Sex: Female, Male Male | 59 Participants | 29 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 42 / 119 | 19 / 52 | 4 / 7 |
| serious Total, serious adverse events | 9 / 119 | 4 / 52 | 0 / 7 |
Outcome results
Primary
Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2
BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. The data were analyzed using mixed model repeated measures (MMRM) which contained scheduled visit, the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate and treatment group by visit and visit by centered baseline BCVA interactions. A positive change from baseline indicated improvement.
Time frame: Baseline, Month 2
Population: The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and Month 2, were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab | Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2 | 9.5 letters | Standard Error 0.95 |
| Sham Control | Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2 | -0.4 letters | Standard Error 1.16 |
p-value: <0.00195% CI: [6.97, 12.91]Mixed Models Analysis
Secondary
Average Change From Baseline in BCVA
BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. BCVA was assessed at each month from Month 1 through Month 6 or at each month from Month 1 through month 12, and the data were averaged. The outcome measure is reporting the change between baseline and average BCVA from Month 1 through Month 6 or from Month 1 through Month 12 (average BCVA - baseline BCVA). A positive change from baseline indicated improvement.
Time frame: Baseline (BL), Month 1 through Month 6, Month 1 through Month 12
Population: The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab | Average Change From Baseline in BCVA | Average change from BL, month 1 through month 6 | 9.53 letters | Standard Deviation 10.467 |
| Ranibizumab | Average Change From Baseline in BCVA | Average change from BL, month 1 through month 12 | 9.99 letters | Standard Deviation 11.528 |
| Sham Control | Average Change From Baseline in BCVA | Average change from BL, month 1 through month 6 | 4.68 letters | Standard Deviation 8.786 |
| Sham Control | Average Change From Baseline in BCVA | Average change from BL, month 1 through month 12 | 6.59 letters | Standard Deviation 10.666 |
Secondary
Change From Baseline in BCVA in Study Eye up to Month 2
BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. The data were analyzed using analysis of covariance (ANCOVA) model which contained the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate. A positive change from baseline indicated improvement.
Time frame: Baseline, Month 1, Month 2
Population: The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab | Change From Baseline in BCVA in Study Eye up to Month 2 | Month 1 | 7.1 letters | Standard Error 0.75 |
| Ranibizumab | Change From Baseline in BCVA in Study Eye up to Month 2 | Month 2 | 9.5 letters | Standard Error 0.91 |
| Sham Control | Change From Baseline in BCVA in Study Eye up to Month 2 | Month 1 | 0.1 letters | Standard Error 1.08 |
| Sham Control | Change From Baseline in BCVA in Study Eye up to Month 2 | Month 2 | -0.4 letters | Standard Error 1.31 |
Secondary
Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye
CSFT was assessed by optical coherence tomography (OCT). A negative change from baseline indicates improvement.
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Population: The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 1 (n=115,56) | -74.4 micrometer (um) | Standard Deviation 81.25 |
| Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 2 (n=114,54) | -76.4 micrometer (um) | Standard Deviation 108.24 |
| Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 3 (n=114,56) | -82.9 micrometer (um) | Standard Deviation 114.26 |
| Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 4 (n=114,56) | -83.5 micrometer (um) | Standard Deviation 104.71 |
| Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 5 (n=116,55) | -83.8 micrometer (um) | Standard Deviation 112.41 |
| Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 6 (n=112,54) | -89.1 micrometer (um) | Standard Deviation 109.19 |
| Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 7 (n=114,55) | -83.1 micrometer (um) | Standard Deviation 105.97 |
| Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 8 (n=111,55) | -94.7 micrometer (um) | Standard Deviation 111.54 |
| Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 9 (n=110,55) | -90.0 micrometer (um) | Standard Deviation 112.44 |
| Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 10 (n=108,53) | -100.5 micrometer (um) | Standard Deviation 119.45 |
| Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 11 (n=110,55) | -99.5 micrometer (um) | Standard Deviation 112.38 |
| Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 12 (n=109,55) | -102.7 micrometer (um) | Standard Deviation 117.27 |
| Sham Control | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 11 (n=110,55) | -82.8 micrometer (um) | Standard Deviation 158.78 |
| Sham Control | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 1 (n=115,56) | 3.3 micrometer (um) | Standard Deviation 89.43 |
| Sham Control | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 7 (n=114,55) | -84.5 micrometer (um) | Standard Deviation 141.36 |
| Sham Control | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 2 (n=114,54) | 1.9 micrometer (um) | Standard Deviation 119.44 |
| Sham Control | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 10 (n=108,53) | -85.4 micrometer (um) | Standard Deviation 136.9 |
| Sham Control | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 3 (n=114,56) | -59.1 micrometer (um) | Standard Deviation 142.37 |
| Sham Control | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 8 (n=111,55) | -97.9 micrometer (um) | Standard Deviation 118.34 |
| Sham Control | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 4 (n=114,56) | -68.4 micrometer (um) | Standard Deviation 155.26 |
| Sham Control | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 12 (n=109,55) | -91.7 micrometer (um) | Standard Deviation 152.36 |
| Sham Control | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 5 (n=116,55) | -89.4 micrometer (um) | Standard Deviation 130.68 |
| Sham Control | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 9 (n=110,55) | -93.5 micrometer (um) | Standard Deviation 113.88 |
| Sham Control | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 6 (n=112,54) | -85.9 micrometer (um) | Standard Deviation 117.54 |
Secondary
Change From Baseline in Central Subfield Volume (CSFV) in Study Eye
CSFV was assessed OCT. A negative change from baseline indicates improvement.
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Population: The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 1 (n=115,56) | -0.354 microliter (ul) | Standard Deviation 0.4103 |
| Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 2 (n=114,54) | -0.357 microliter (ul) | Standard Deviation 0.548 |
| Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 3 (n=114,56) | -0.369 microliter (ul) | Standard Deviation 0.5506 |
| Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 4 (n=114,56) | -0.371 microliter (ul) | Standard Deviation 0.4798 |
| Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 5 (n=116,55) | -0.392 microliter (ul) | Standard Deviation 0.5404 |
| Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 6 (n=112,54) | -0.409 microliter (ul) | Standard Deviation 0.5305 |
| Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 7 (n=114,54) | -0.366 microliter (ul) | Standard Deviation 0.4905 |
| Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 8 (n=110,55) | -0.414 microliter (ul) | Standard Deviation 0.5021 |
| Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 9 (n=110,55) | -0.404 microliter (ul) | Standard Deviation 0.5182 |
| Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 10 (n=108,53) | -0.437 microliter (ul) | Standard Deviation 0.5506 |
| Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 11 (n=110,55) | -0.448 microliter (ul) | Standard Deviation 0.5285 |
| Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 12 (n=109,55) | -0.441 microliter (ul) | Standard Deviation 0.546 |
| Sham Control | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 11 (n=110,55) | -0.352 microliter (ul) | Standard Deviation 0.7021 |
| Sham Control | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 1 (n=115,56) | 0.012 microliter (ul) | Standard Deviation 0.3608 |
| Sham Control | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 7 (n=114,54) | -0.374 microliter (ul) | Standard Deviation 0.5966 |
| Sham Control | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 2 (n=114,54) | -0.006 microliter (ul) | Standard Deviation 0.5792 |
| Sham Control | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 10 (n=108,53) | -0.385 microliter (ul) | Standard Deviation 0.5688 |
| Sham Control | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 3 (n=114,56) | -0.269 microliter (ul) | Standard Deviation 0.6583 |
| Sham Control | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 8 (n=110,55) | -0.411 microliter (ul) | Standard Deviation 0.497 |
| Sham Control | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 4 (n=114,56) | -0.291 microliter (ul) | Standard Deviation 0.7647 |
| Sham Control | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 12 (n=109,55) | -0.378 microliter (ul) | Standard Deviation 0.6704 |
| Sham Control | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 5 (n=116,55) | -0.381 microliter (ul) | Standard Deviation 0.575 |
| Sham Control | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 9 (n=110,55) | -0.413 microliter (ul) | Standard Deviation 0.5251 |
| Sham Control | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 6 (n=112,54) | -0.375 microliter (ul) | Standard Deviation 0.531 |
Secondary
Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters
VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.
Time frame: Month 2, Month 6, Month 12
Population: The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 2,>=15 letters or reaching 84 let.(n=118,57) | 37 Participants |
| Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 2, >=10 letters (n=118,57) | 50 Participants |
| Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 2, >=5 letters (n=118,57) | 83 Participants |
| Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 2, >=1 letter (118,57) | 101 Participants |
| Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 6,>=15 letters or reaching 84 let.(n=118,54) | 53 Participants |
| Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 6, >=10 letters (n=118,54) | 67 Participants |
| Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 6, >= 5 letters (n=118,54) | 88 Participants |
| Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 6, >= 1 letter (n=118,54) | 104 Participants |
| Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 12,>=15 letters or reaching 84 let.;n=113,55 | 55 Participants |
| Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 12, >=10 letters (n=113,55) | 64 Participants |
| Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 12, >=5 letters (n=113,55) | 81 Participants |
| Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 12, >=1 letter (n=113,55) | 100 Participants |
| Sham Control | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 12, >=5 letters (n=113,55) | 34 Participants |
| Sham Control | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 2,>=15 letters or reaching 84 let.(n=118,57) | 7 Participants |
| Sham Control | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 6, >= 5 letters (n=118,54) | 34 Participants |
| Sham Control | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 2, >=10 letters (n=118,57) | 8 Participants |
| Sham Control | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 12, >=10 letters (n=113,55) | 28 Participants |
| Sham Control | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 2, >=5 letters (n=118,57) | 16 Participants |
| Sham Control | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 6, >= 1 letter (n=118,54) | 39 Participants |
| Sham Control | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 2, >=1 letter (118,57) | 27 Participants |
| Sham Control | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 12, >=1 letter (n=113,55) | 42 Participants |
| Sham Control | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 6,>=15 letters or reaching 84 let.(n=118,54) | 20 Participants |
| Sham Control | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 12,>=15 letters or reaching 84 let.;n=113,55 | 23 Participants |
| Sham Control | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 6, >=10 letters (n=118,54) | 24 Participants |
Secondary
Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss
VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.
Time frame: Month 2, Month 6, Month 12
Population: The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 2, loss of >1 letter (n=118,57) | 10 Participants |
| Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 2, loss of >5 letters (n=118,57) | 3 Participants |
| Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 2, loss of >10 letters (n=118,57) | 1 Participants |
| Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 2, loss of >15 letters (n=118,57) | 1 Participants |
| Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 6, loss of >1 letter (n=118,54) | 10 Participants |
| Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 6, loss of >5 letters (n=118,54) | 7 Participants |
| Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 6, loss of >10 letters (n=118,54) | 6 Participants |
| Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 6, loss of >15 letters (n=118,54) | 3 Participants |
| Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 12, loss of >1 letter (n=113,55) | 9 Participants |
| Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 12, loss of >5 letters (n=113,55) | 6 Participants |
| Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 12, loss of >10 letters (n=113,55) | 5 Participants |
| Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 12,loss of >15 letters (n=113,55) | 3 Participants |
| Sham Control | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 12, loss of >10 letters (n=113,55) | 4 Participants |
| Sham Control | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 2, loss of >1 letter (n=118,57) | 24 Participants |
| Sham Control | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 6, loss of >10 letters (n=118,54) | 2 Participants |
| Sham Control | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 2, loss of >5 letters (n=118,57) | 12 Participants |
| Sham Control | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 12, loss of >5 letters (n=113,55) | 6 Participants |
| Sham Control | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 2, loss of >10 letters (n=118,57) | 5 Participants |
| Sham Control | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 6, loss of >15 letters (n=118,54) | 2 Participants |
| Sham Control | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 2, loss of >15 letters (n=118,57) | 3 Participants |
| Sham Control | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 12,loss of >15 letters (n=113,55) | 2 Participants |
| Sham Control | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 6, loss of >1 letter (n=118,54) | 9 Participants |
| Sham Control | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 12, loss of >1 letter (n=113,55) | 10 Participants |
| Sham Control | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 6, loss of >5 letters (n=118,54) | 5 Participants |
Secondary
Number of Participants With Presence of Active Chorioretinal Leakage
The presence of active chorioretinal leakage was assessed by photography imaging, i.e. fluorescein angiography (FA).
Time frame: Baseline, Month 2, Month 6, Month 12
Population: The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab | Number of Participants With Presence of Active Chorioretinal Leakage | Baseline, Absent (n=106,50) | 2 Participants |
| Ranibizumab | Number of Participants With Presence of Active Chorioretinal Leakage | Month 6, Absent (n=108,45) | 64 Participants |
| Ranibizumab | Number of Participants With Presence of Active Chorioretinal Leakage | Month 2, Absent (n=106,50) | 37 Participants |
| Ranibizumab | Number of Participants With Presence of Active Chorioretinal Leakage | Month 6, Definite (n=108,45) | 44 Participants |
| Ranibizumab | Number of Participants With Presence of Active Chorioretinal Leakage | Month 12, Absent (n=103,47) | 81 Participants |
| Ranibizumab | Number of Participants With Presence of Active Chorioretinal Leakage | Baseline, Definite (n=106,50) | 104 Participants |
| Ranibizumab | Number of Participants With Presence of Active Chorioretinal Leakage | Month 12, Definite (n=103,47) | 22 Participants |
| Ranibizumab | Number of Participants With Presence of Active Chorioretinal Leakage | Month 2, Definite (n=106,50) | 69 Participants |
| Sham Control | Number of Participants With Presence of Active Chorioretinal Leakage | Month 12, Definite (n=103,47) | 10 Participants |
| Sham Control | Number of Participants With Presence of Active Chorioretinal Leakage | Baseline, Absent (n=106,50) | 1 Participants |
| Sham Control | Number of Participants With Presence of Active Chorioretinal Leakage | Baseline, Definite (n=106,50) | 49 Participants |
| Sham Control | Number of Participants With Presence of Active Chorioretinal Leakage | Month 2, Absent (n=106,50) | 4 Participants |
| Sham Control | Number of Participants With Presence of Active Chorioretinal Leakage | Month 2, Definite (n=106,50) | 46 Participants |
| Sham Control | Number of Participants With Presence of Active Chorioretinal Leakage | Month 6, Absent (n=108,45) | 29 Participants |
| Sham Control | Number of Participants With Presence of Active Chorioretinal Leakage | Month 12, Absent (n=103,47) | 37 Participants |
| Sham Control | Number of Participants With Presence of Active Chorioretinal Leakage | Month 6, Definite (n=108,45) | 16 Participants |
Secondary
Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline
The presence of intra-retinal fluid was assessed by OCT.
Time frame: Baseline, Month 2, Month 6, Month 12
Population: The FAS was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants (n), with values 'Absent' or 'Definite' for both the baseline and corresponding post-baseline time point, were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab | Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline | Baseline, Absent (n=116,56) | 70 Participants |
| Ranibizumab | Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline | Baseline, Definite (n=116,56) | 46 Participants |
| Ranibizumab | Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline | Month 2, Absent (n=116,56) | 97 Participants |
| Ranibizumab | Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline | Month 2, Definite (n=116,56) | 19 Participants |
| Ranibizumab | Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline | Month 6, Absent (n=116,54) | 100 Participants |
| Ranibizumab | Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline | Month 6, Definite (n=116,54) | 16 Participants |
| Ranibizumab | Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline | Month 12, Absent (n=111,55) | 95 Participants |
| Ranibizumab | Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline | Month 12, Definite (n=111,55) | 16 Participants |
| Sham Control | Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline | Month 12, Definite (n=111,55) | 10 Participants |
| Sham Control | Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline | Baseline, Absent (n=116,56) | 32 Participants |
| Sham Control | Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline | Month 6, Absent (n=116,54) | 43 Participants |
| Sham Control | Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline | Baseline, Definite (n=116,56) | 24 Participants |
| Sham Control | Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline | Month 12, Absent (n=111,55) | 45 Participants |
| Sham Control | Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline | Month 2, Absent (n=116,56) | 29 Participants |
| Sham Control | Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline | Month 6, Definite (n=116,54) | 11 Participants |
| Sham Control | Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline | Month 2, Definite (n=116,56) | 27 Participants |
Secondary
Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline
Presence of subretinal fluid in study eye compared to baseline
Time frame: Baseline, Month 2, Month 6, Month 12
Population: The FAS was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants (n), with values 'Absent' or 'Definite' for both the baseline and corresponding post-baseline time point, were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab | Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline | Baseline, Absent (n=116,56) | 16 Participants |
| Ranibizumab | Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline | Baseline, Definite (n=116,56) | 100 Participants |
| Ranibizumab | Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline | Month 2, Absent (n=116,56) | 72 Participants |
| Ranibizumab | Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline | Month 2, Definite (n=116,56) | 44 Participants |
| Ranibizumab | Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline | Month 6, Absent (n=116,54) | 77 Participants |
| Ranibizumab | Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline | Month 6, Definite (n=116,54) | 39 Participants |
| Ranibizumab | Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline | Month 12, Absent (n=111,55) | 78 Participants |
| Ranibizumab | Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline | Month 12, Definite (n=111,55) | 33 Participants |
| Sham Control | Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline | Month 12, Definite (n=111,55) | 14 Participants |
| Sham Control | Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline | Baseline, Absent (n=116,56) | 6 Participants |
| Sham Control | Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline | Month 6, Absent (n=116,54) | 34 Participants |
| Sham Control | Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline | Baseline, Definite (n=116,56) | 50 Participants |
| Sham Control | Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline | Month 12, Absent (n=111,55) | 41 Participants |
| Sham Control | Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline | Month 2, Absent (n=116,56) | 11 Participants |
| Sham Control | Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline | Month 6, Definite (n=116,54) | 20 Participants |
| Sham Control | Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline | Month 2, Definite (n=116,56) | 45 Participants |
Secondary
Number of Participants With Ranibizumab Treatments in Study Eye
The number of participants administered study treatments, according to treatment frequency, was assessed.
Time frame: Month 12
Population: Safety set: The safety set included randomized participants who received at least one dose of study treatment and was based on the actual treatment received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 11 | 6 Participants |
| Ranibizumab | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 8 | 8 Participants |
| Ranibizumab | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 5 | 9 Participants |
| Ranibizumab | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 2 | 12 Participants |
| Ranibizumab | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 7 | 2 Participants |
| Ranibizumab | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 6 | 11 Participants |
| Ranibizumab | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 0 | 0 Participants |
| Ranibizumab | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 1 | 12 Participants |
| Ranibizumab | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 10 | 7 Participants |
| Ranibizumab | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 3 | 19 Participants |
| Ranibizumab | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 12 | 15 Participants |
| Ranibizumab | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 9 | 5 Participants |
| Ranibizumab | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 4 | 13 Participants |
| Sham Control | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 6 | 6 Participants |
| Sham Control | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 0 | 0 Participants |
| Sham Control | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 1 | 5 Participants |
| Sham Control | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 2 | 6 Participants |
| Sham Control | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 3 | 7 Participants |
| Sham Control | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 4 | 6 Participants |
| Sham Control | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 5 | 5 Participants |
| Sham Control | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 7 | 2 Participants |
| Sham Control | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 8 | 1 Participants |
| Sham Control | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 9 | 4 Participants |
| Sham Control | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 10 | 10 Participants |
| Sham Control | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 11 | 0 Participants |
| Sham Control | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 12 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 8 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 3 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 11 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 9 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 2 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 0 | 7 Participants |
| Sham Without Ranibizumab | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 10 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 6 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 5 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 1 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 7 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 4 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Ranibizumab Treatments in Study Eye | Frequency of injections = 12 | 0 Participants |
Secondary
Number of Participants With Requirement for Rescue Treatment at Month 1
Rescue treatment with laser photocoagulation or periocular treatment could be administered at Month 1 only if the participant had a visual acuity loss of \> 5 letters due to disease activity from baseline to Month 1.
Time frame: Month 1
Population: The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at Month 1, were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ranibizumab | Number of Participants With Requirement for Rescue Treatment at Month 1 | 0 Participants |
| Sham Control | Number of Participants With Requirement for Rescue Treatment at Month 1 | 1 Participants |
Secondary
Number of Participants With Re-treatments
The number of participants, administered re-treatments according to treatment frequency, was assessed. Re-treatment was defined as an administration of study medication following at least one non-missed visit where treatment was not administered in the study eye. Up to month 12, the maximum number of retreatments was 5.
Time frame: Month 12
Population: Safety set: The safety set included randomized participants who received at least one dose of study treatment and was based on the actual treatment received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab | Number of Participants With Re-treatments | Frequency of re-treatment = 1 | 25 Paticipants |
| Ranibizumab | Number of Participants With Re-treatments | Frequency of re-treatment = 2 | 22 Paticipants |
| Ranibizumab | Number of Participants With Re-treatments | Frequency of re-treatment = 3 | 9 Paticipants |
| Ranibizumab | Number of Participants With Re-treatments | Frequency of re-treatment = 4 | 5 Paticipants |
| Sham Control | Number of Participants With Re-treatments | Frequency of re-treatment = 4 | 2 Paticipants |
| Sham Control | Number of Participants With Re-treatments | Frequency of re-treatment = 1 | 21 Paticipants |
| Sham Control | Number of Participants With Re-treatments | Frequency of re-treatment = 3 | 4 Paticipants |
| Sham Control | Number of Participants With Re-treatments | Frequency of re-treatment = 2 | 10 Paticipants |
| Sham Without Ranibizumab | Number of Participants With Re-treatments | Frequency of re-treatment = 4 | 0 Paticipants |
| Sham Without Ranibizumab | Number of Participants With Re-treatments | Frequency of re-treatment = 2 | 0 Paticipants |
| Sham Without Ranibizumab | Number of Participants With Re-treatments | Frequency of re-treatment = 3 | 0 Paticipants |
| Sham Without Ranibizumab | Number of Participants With Re-treatments | Frequency of re-treatment = 1 | 0 Paticipants |
Secondary
Number of Primary Reasons for Decision to Treat by Investigator
The total number of primary reasons for decisions to treat was assessed. A single participant could have had multiple primary reasons for treatment.
Time frame: Month 12
Population: Safety set: The safety set included randomized participants who received at least one dose of study treatment and was based on the actual treatment received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab | Number of Primary Reasons for Decision to Treat by Investigator | Vision impairment | 29 Number of primary reasons |
| Ranibizumab | Number of Primary Reasons for Decision to Treat by Investigator | OCT abnormality | 522 Number of primary reasons |
| Ranibizumab | Number of Primary Reasons for Decision to Treat by Investigator | FA abnormality | 21 Number of primary reasons |
| Ranibizumab | Number of Primary Reasons for Decision to Treat by Investigator | Color fundus photography abnormality | 1 Number of primary reasons |
| Ranibizumab | Number of Primary Reasons for Decision to Treat by Investigator | Clinical abnormality | 6 Number of primary reasons |
| Ranibizumab | Number of Primary Reasons for Decision to Treat by Investigator | Without documentation | 1 Number of primary reasons |
| Sham Control | Number of Primary Reasons for Decision to Treat by Investigator | Without documentation | 0 Number of primary reasons |
| Sham Control | Number of Primary Reasons for Decision to Treat by Investigator | Vision impairment | 9 Number of primary reasons |
| Sham Control | Number of Primary Reasons for Decision to Treat by Investigator | Color fundus photography abnormality | 0 Number of primary reasons |
| Sham Control | Number of Primary Reasons for Decision to Treat by Investigator | Clinical abnormality | 0 Number of primary reasons |
| Sham Control | Number of Primary Reasons for Decision to Treat by Investigator | OCT abnormality | 306 Number of primary reasons |
| Sham Control | Number of Primary Reasons for Decision to Treat by Investigator | FA abnormality | 13 Number of primary reasons |
| Sham Without Ranibizumab | Number of Primary Reasons for Decision to Treat by Investigator | OCT abnormality | 1 Number of primary reasons |
| Sham Without Ranibizumab | Number of Primary Reasons for Decision to Treat by Investigator | FA abnormality | 0 Number of primary reasons |
| Sham Without Ranibizumab | Number of Primary Reasons for Decision to Treat by Investigator | Without documentation | 0 Number of primary reasons |
| Sham Without Ranibizumab | Number of Primary Reasons for Decision to Treat by Investigator | Color fundus photography abnormality | 0 Number of primary reasons |
| Sham Without Ranibizumab | Number of Primary Reasons for Decision to Treat by Investigator | Vision impairment | 0 Number of primary reasons |
| Sham Without Ranibizumab | Number of Primary Reasons for Decision to Treat by Investigator | Clinical abnormality | 0 Number of primary reasons |