Macular Edema (ME)
Conditions
Keywords
Vision Impairment
Brief summary
To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections in adult patients with visual impairment due to macular edema (ME).
Interventions
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.
DRUGRanibizumab
Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.
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
* Diagnosis of active ME secondary to any causes (for adult patients: except diabetic macular edema (DME), age-related macular degeneration (AMD) and retinal vein occlusion (RVO)); * BCVA must be between ≥ 24 and ≤ 83 letters; * Visual loss should be mainly due to the presence of any eligible types of ME.
Exclusion criteria
* Women of child-bearing potential, * Active malignancies; * History of stroke less than 6 months prior to screening; * Uncontrolled systemic inflammation or infection, related directly to the underlying causal disease of ME; * Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation; * Any type of advanced, severe or unstable ocular disease or its reatment; * ME with a high likelihood of spontaneous resolution. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye | 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. 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 wasassessed by optical coherence tomography (OCT). A negative change from baseline indicates improvement. |
| Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | 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 or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline | Month 2, Month 6, Month 12 | The presence of intra-retinal fluid was assessed by OCT. |
| Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline | Month 2, Month 6, Month 12 | The presence of subretinal fluid was assessed by OCT. |
| Number of Participants With Presence of Active Macular Edema (ME) Leakage | Month 2 | The presence of active ME leakage was assessed by fluorescein angiography (FA). |
| Number of Participants Requiring 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. |
| 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. A positive change from baseline indicated improvement. |
| 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. |
| 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 Ranibizumab Treatments | Month 12 | The number of participants administered study treatments, according to treatment frequency, was assessed. |
| Number of Participants With Re-treatments | Month 6, 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 | 12 months | The total number of primary reasons for decisions to treat was assessed. A single participant could have had multiple primary reasons for treatment. |
| 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. A positive change from baseline indicated improvement. |
Countries
Australia, Belgium, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Latvia, Netherlands, Russia, Singapore, Slovakia, South Korea, Spain, Switzerland, Turkey (Türkiye), United Kingdom
Participant flow
Recruitment details
A total of 181 participants were enrolled. Of these, 178 adults were randomized in a 2:1 ratio and considered for analysis. The 3 adolescent participants, non-randomized, received open-label treatment and were not included in the analyses. Therefore, the number enrolled = 181 differs from the number randomized = 178 in the participant flow.
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. | 118 |
| Sham 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. | 60 |
| Total | 178 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Death | 1 | 2 |
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Physician Decision | 4 | 2 |
| Overall Study | Protocol deviation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 6 |
Baseline characteristics
| Characteristic | Ranibizumab | Sham | Total |
|---|---|---|---|
| Age, Continuous | 63.5 Years STANDARD_DEVIATION 13.97 | 61.8 Years STANDARD_DEVIATION 15.55 | 62.9 Years STANDARD_DEVIATION 14.5 |
| Sex: Female, Male Female | 45 Participants | 23 Participants | 68 Participants |
| Sex: Female, Male Male | 73 Participants | 37 Participants | 110 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 | 58 / 119 | 21 / 56 | 0 / 2 |
| serious Total, serious adverse events | 15 / 119 | 6 / 56 | 1 / 2 |
Outcome results
Primary
Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye
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. A positive change from baseline indicated improvement.
Time frame: Baseline, Month 2
Population: Full analysis set: The full analysis set included all randomized participants who received at least one dose of study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab | Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye | 5.7 letters | Standard Error 0.81 |
| Sham With Ranibizumab | Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye | 2.9 letters | Standard Error 0.89 |
p-value: 0.011195% CI: [0.4, 5.16]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. A positive change from baseline indicated improvement.
Time frame: Baseline (BL), month 1 through month 6, month 1 through month 12
Population: The FAS was used for this analysis. The FAS included randomized participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab | Average Change From Baseline in BCVA | Average change from BL, month 1 through month 6 | 6.39 letters | Standard Deviation 8.405 |
| Ranibizumab | Average Change From Baseline in BCVA | Average change from BL, month 1 through month 12 | 7.40 letters | Standard Deviation 9.052 |
| Sham With Ranibizumab | Average Change From Baseline in BCVA | Average change from BL, month 1 through month 6 | 4.50 letters | Standard Deviation 8.095 |
| Sham With Ranibizumab | Average Change From Baseline in BCVA | Average change from BL, month 1 through month 12 | 5.82 letters | Standard Deviation 8.927 |
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. 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. The FAS included all randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that 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 (n=116,59) | 4.7 letters | Standard Error 0.7 |
| Ranibizumab | Change From Baseline in BCVA in Study Eye up to Month 2 | Month 2 (n=114,59) | 5.8 letters | Standard Error 0.76 |
| Sham With Ranibizumab | Change From Baseline in BCVA in Study Eye up to Month 2 | Month 1 (n=116,59) | 1.4 letters | Standard Error 0.98 |
| Sham With Ranibizumab | Change From Baseline in BCVA in Study Eye up to Month 2 | Month 2 (n=114,59) | 2.8 letters | Standard Error 1.05 |
Secondary
Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye
CSFT wasassessed 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 randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 1 (n=112,59) | -83.6 micrometers (um) | Standard Deviation 127.45 |
| Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 6 (n=109,54) | -110.6 micrometers (um) | Standard Deviation 133.1 |
| Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 3 (n=113,59) | -86.5 micrometers (um) | Standard Deviation 136.43 |
| Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 7 (n=105,52) | -113.3 micrometers (um) | Standard Deviation 130.84 |
| Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 9 (n=105,52) | -111.6 micrometers (um) | Standard Deviation 127.99 |
| Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 4 (n=109,57) | -94.5 micrometers (um) | Standard Deviation 141.55 |
| Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 10 (n=103,50) | -114.1 micrometers (um) | Standard Deviation 131.12 |
| Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 2 (n=112,59) | -82.5 micrometers (um) | Standard Deviation 140.06 |
| Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 11 (n=101,49) | -112.1 micrometers (um) | Standard Deviation 124 |
| Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 5 (n=105,57) | -98.6 micrometers (um) | Standard Deviation 136.28 |
| Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 12 (n=103,50) | -121.0 micrometers (um) | Standard Deviation 124.67 |
| Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 8 (n=105,51) | -113.1 micrometers (um) | Standard Deviation 127.11 |
| Sham With Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 12 (n=103,50) | -116.8 micrometers (um) | Standard Deviation 137.99 |
| Sham With Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 8 (n=105,51) | -107.7 micrometers (um) | Standard Deviation 157.4 |
| Sham With Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 1 (n=112,59) | -14.3 micrometers (um) | Standard Deviation 97.36 |
| Sham With Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 2 (n=112,59) | -30.6 micrometers (um) | Standard Deviation 102.77 |
| Sham With Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 3 (n=113,59) | -92.2 micrometers (um) | Standard Deviation 129.85 |
| Sham With Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 4 (n=109,57) | -95.5 micrometers (um) | Standard Deviation 140.68 |
| Sham With Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 5 (n=105,57) | -107.6 micrometers (um) | Standard Deviation 142.22 |
| Sham With Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 6 (n=109,54) | -84.1 micrometers (um) | Standard Deviation 137.86 |
| Sham With Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 7 (n=105,52) | -112.9 micrometers (um) | Standard Deviation 148.13 |
| Sham With Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 9 (n=105,52) | -116.3 micrometers (um) | Standard Deviation 146.43 |
| Sham With Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 10 (n=103,50) | -116.6 micrometers (um) | Standard Deviation 147.26 |
| Sham With Ranibizumab | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Month 11 (n=101,49) | -123.5 micrometers (um) | Standard Deviation 140.65 |
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: 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 randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 1 (n=112,59) | -0.296 microliters (ul) | Standard Deviation 0.457 |
| Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 12 (n=103,50) | -0.447 microliters (ul) | Standard Deviation 0.4837 |
| Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 2 (n=112,59) | -0.276 microliters (ul) | Standard Deviation 0.5362 |
| Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 3 (n=113,59) | -0.322 microliters (ul) | Standard Deviation 0.5812 |
| Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 4 (n=109,57) | -0.333 microliters (ul) | Standard Deviation 0.5568 |
| Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 5 (n=105,57) | -0.383 microliters (ul) | Standard Deviation 0.5592 |
| Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 6 (n=109,54) | -0.388 microliters (ul) | Standard Deviation 0.5167 |
| Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 7 (n=105,52) | -0.438 microliters (ul) | Standard Deviation 0.5267 |
| Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 8 (n=105,51) | -0.405 microliters (ul) | Standard Deviation 0.5074 |
| Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 9 (n=105,52) | -0.446 microliters (ul) | Standard Deviation 0.6066 |
| Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 10 (n=103,50) | -0.439 microliters (ul) | Standard Deviation 0.6241 |
| Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 11 (n=101,49) | -0.406 microliters (ul) | Standard Deviation 0.4871 |
| Sham With Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 10 (n=103,50) | -0.433 microliters (ul) | Standard Deviation 0.6407 |
| Sham With Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 6 (n=109,54) | -0.344 microliters (ul) | Standard Deviation 0.553 |
| Sham With Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 12 (n=103,50) | -0.455 microliters (ul) | Standard Deviation 0.591 |
| Sham With Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 1 (n=112,59) | -0.032 microliters (ul) | Standard Deviation 0.3969 |
| Sham With Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 9 (n=105,52) | -0.444 microliters (ul) | Standard Deviation 0.621 |
| Sham With Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 2 (n=112,59) | -0.104 microliters (ul) | Standard Deviation 0.3958 |
| Sham With Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 7 (n=105,52) | -0.438 microliters (ul) | Standard Deviation 0.6098 |
| Sham With Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 3 (n=113,59) | -0.348 microliters (ul) | Standard Deviation 0.5075 |
| Sham With Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 11 (n=101,49) | -0.459 microliters (ul) | Standard Deviation 0.6157 |
| Sham With Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 4 (n=109,57) | -0.378 microliters (ul) | Standard Deviation 0.5436 |
| Sham With Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 8 (n=105,51) | -0.421 microliters (ul) | Standard Deviation 0.6484 |
| Sham With Ranibizumab | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Month 5 (n=105,57) | -0.401 microliters (ul) | Standard Deviation 0.5893 |
Secondary
Number of Participants Requiring 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 FAS was used for this analysis. The FAS included all randomized participants who received at least one dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ranibizumab | Number of Participants Requiring Rescue Treatment at Month 1 | 0 Participants |
| Sham With Ranibizumab | Number of Participants Requiring Rescue Treatment at Month 1 | 0 Participants |
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 randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 12, Gain of >= 10 letters (n=106,50) | 55 Participants |
| Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 2, Gain of >= 15 letters (n=114,59) | 26 Participants |
| Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 2, Gain of >= 10 letters (n=114,59) | 35 Participants |
| Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 2, Gain of >= 5 letters (n=114,59) | 55 Participants |
| Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 2, Gain of >= 1 letter (n=114,59) | 80 Participants |
| Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 6, Gain of >= 15 letters (n=111,55) | 30 Participants |
| Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 6, Gain of >= 10 letters (n=111,55) | 41 Participants |
| Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 6, Gain of >= 5 letters (n=111,55) | 67 Participants |
| Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 6, Gain of >= 1 letters (n=111,55) | 87 Participants |
| Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 12, Gain of >= 15 letters (n=106,50) | 44 Participants |
| Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 12, Gain of >= 5 letters (n=106,50) | 72 Participants |
| Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 12, Gain of >= 1 letters (n=106,50) | 86 Participants |
| Sham With Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 12, Gain of >= 5 letters (n=106,50) | 37 Participants |
| Sham With Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 12, Gain of >= 10 letters (n=106,50) | 27 Participants |
| Sham With Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 6, Gain of >= 10 letters (n=111,55) | 21 Participants |
| Sham With Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 2, Gain of >= 15 letters (n=114,59) | 7 Participants |
| Sham With Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 12, Gain of >= 15 letters (n=106,50) | 22 Participants |
| Sham With Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 2, Gain of >= 10 letters (n=114,59) | 11 Participants |
| Sham With Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 6, Gain of >= 5 letters (n=111,55) | 34 Participants |
| Sham With Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 2, Gain of >= 5 letters (n=114,59) | 19 Participants |
| Sham With Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 12, Gain of >= 1 letters (n=106,50) | 42 Participants |
| Sham With Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 2, Gain of >= 1 letter (n=114,59) | 38 Participants |
| Sham With Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 6, Gain of >= 1 letters (n=111,55) | 40 Participants |
| Sham With Ranibizumab | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 6, Gain of >= 15 letters (n=111,55) | 15 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 randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 12, Loss of >= 1 letter (n=106,50) | 10 Participants |
| Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 2, Loss of >1 letter (n=114,59) | 17 Participants |
| Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 2, Loss of >5 letters (n=114,59) | 8 Participants |
| Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 2, Loss of >10 letters (n=114,59) | 2 Participants |
| Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 2, Loss of >15 letters (n=114,59) | 0 Participants |
| Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 6, Loss of >1 letter (n=111,55) | 14 Participants |
| Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 6, Loss of >5 letters (n=111,55) | 5 Participants |
| Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 6, Loss of >10 letters (n=111,55) | 3 Participants |
| Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 6, Loss of >15 letters (n=111,55) | 1 Participants |
| Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 12, Loss of >= 5 letters (n=106,50) | 6 Participants |
| Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 12, Loss of >= 10 letters (n=106,50) | 2 Participants |
| Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 12, Loss of >= 15 letters (n=106,50) | 1 Participants |
| Sham With Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 12, Loss of >= 10 letters (n=106,50) | 3 Participants |
| Sham With Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 12, Loss of >= 1 letter (n=106,50) | 5 Participants |
| Sham With Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 6, Loss of >5 letters (n=111,55) | 7 Participants |
| Sham With Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 2, Loss of >1 letter (n=114,59) | 9 Participants |
| Sham With Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 12, Loss of >= 5 letters (n=106,50) | 3 Participants |
| Sham With Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 2, Loss of >5 letters (n=114,59) | 4 Participants |
| Sham With Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 6, Loss of >10 letters (n=111,55) | 4 Participants |
| Sham With Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 2, Loss of >10 letters (n=114,59) | 3 Participants |
| Sham With Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 12, Loss of >= 15 letters (n=106,50) | 2 Participants |
| Sham With Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 2, Loss of >15 letters (n=114,59) | 0 Participants |
| Sham With Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 6, Loss of >15 letters (n=111,55) | 1 Participants |
| Sham With Ranibizumab | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 6, Loss of >1 letter (n=111,55) | 12 Participants |
Secondary
Number of Participants With Presence of Active Macular Edema (ME) Leakage
The presence of active ME leakage was assessed by fluorescein angiography (FA).
Time frame: Month 2
Population: The FAS was used this analysis. The FAS included randomized participants who received at least one dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ranibizumab | Number of Participants With Presence of Active Macular Edema (ME) Leakage | 96 Participants |
| Sham With Ranibizumab | Number of Participants With Presence of Active Macular Edema (ME) Leakage | 53 Participants |
Secondary
Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline
The presence of intra-retinal fluid was assessed by OCT.
Time frame: 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 or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline | Month 2, Absent (n=112,59) | 98 Participants |
| Ranibizumab | Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline | Month 2, Definite (n=112,59) | 14 Participants |
| Ranibizumab | Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline | Month 6, Absent (n=109,55) | 97 Participants |
| Ranibizumab | Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline | Month 6, Definite (n=109,55) | 12 Participants |
| Ranibizumab | Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline | Month 12, Absent (n=103,50) | 78 Participants |
| Ranibizumab | Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline | Month 12, Definite (n=103,50) | 25 Participants |
| Sham With Ranibizumab | Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline | Month 12, Absent (n=103,50) | 39 Participants |
| Sham With Ranibizumab | Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline | Month 2, Absent (n=112,59) | 46 Participants |
| Sham With Ranibizumab | Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline | Month 6, Definite (n=109,55) | 12 Participants |
| Sham With Ranibizumab | Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline | Month 2, Definite (n=112,59) | 13 Participants |
| Sham With Ranibizumab | Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline | Month 12, Definite (n=103,50) | 11 Participants |
| Sham With Ranibizumab | Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline | Month 6, Absent (n=109,55) | 43 Participants |
Secondary
Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline
The presence of subretinal fluid was assessed by OCT.
Time frame: 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 or Absence of Subretinal Fluid in Study Eye Compared to Baseline | Month 12, Absent (n=104,50) | 77 Participants |
| Ranibizumab | Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline | Month 2, Absent (n=113,59) | 77 Participants |
| Ranibizumab | Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline | Month 6, Absent (n=109,55) | 75 Participants |
| Ranibizumab | Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline | Month 2, Definite (n=110,55) | 36 Participants |
| Ranibizumab | Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline | Month 6, Definite (n=109,55) | 35 Participants |
| Ranibizumab | Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline | Month 12, Definite (n=103,50) | 27 Participants |
| Sham With Ranibizumab | Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline | Month 6, Definite (n=109,55) | 20 Participants |
| Sham With Ranibizumab | Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline | Month 6, Absent (n=109,55) | 35 Participants |
| Sham With Ranibizumab | Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline | Month 12, Absent (n=104,50) | 37 Participants |
| Sham With Ranibizumab | Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline | Month 12, Definite (n=103,50) | 13 Participants |
| Sham With Ranibizumab | Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline | Month 2, Absent (n=113,59) | 33 Participants |
| Sham With Ranibizumab | Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline | Month 2, Definite (n=110,55) | 26 Participants |
Secondary
Number of Participants With Ranibizumab Treatments
The number of participants administered study treatments, according to treatment frequency, was assessed.
Time frame: Month 12
Population: The safety set was used for this analysis. The safety set included randomized participants who received at least one dose of study treatment. Two participants from the sham group were included in the ranibizumab group based on the actual treatment received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 12 | 20 Participants |
| Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 10 | 12 Participants |
| Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 3 | 14 Participants |
| Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 5 | 17 Participants |
| Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 0 | 0 Participants |
| Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 1 | 13 Participants |
| Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 2 | 5 Participants |
| Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 8 | 13 Participants |
| Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 6 | 7 Participants |
| Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 11 | 6 Participants |
| Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 7 | 6 Participants |
| Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 9 | 3 Participants |
| Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 4 | 3 Participants |
| Sham With Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 1 | 6 Participants |
| Sham With Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 2 | 3 Participants |
| Sham With Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 5 | 7 Participants |
| Sham With Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 8 | 0 Participants |
| Sham With Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 12 | 0 Participants |
| Sham With Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 0 | 0 Participants |
| Sham With Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 3 | 7 Participants |
| Sham With Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 4 | 5 Participants |
| Sham With Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 6 | 11 Participants |
| Sham With Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 7 | 0 Participants |
| Sham With Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 9 | 6 Participants |
| Sham With Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 10 | 11 Participants |
| Sham With Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 11 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 11 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 6 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 8 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 10 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 7 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 5 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 0 | 2 Participants |
| Sham Without Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 12 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 1 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 3 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 9 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 2 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Ranibizumab Treatments | Frequency of injections = 4 | 0 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 6, month 12
Population: The safety set was used for this analysis. The safety set included randomized participants who received at least one dose of study treatment. Two participants from the sham group were included in the ranibizumab group based on the actual treatment received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab | Number of Participants With Re-treatments | Month 12, Frequency of re-treatment = 1 | 21 Participants |
| Ranibizumab | Number of Participants With Re-treatments | Month 12, Frequency of re-treatment = 3 | 13 Participants |
| Ranibizumab | Number of Participants With Re-treatments | Month 12, Frequency of re-treatment = 2 | 24 Participants |
| Ranibizumab | Number of Participants With Re-treatments | Month 6, Frequency of re-treatment = 1 | 34 Participants |
| Ranibizumab | Number of Participants With Re-treatments | Month 12, Frequency of re-treatment = 5 | 3 Participants |
| Ranibizumab | Number of Participants With Re-treatments | Month 12, Frequency of re-treatment = 4 | 5 Participants |
| Ranibizumab | Number of Participants With Re-treatments | Month 6, Frequency of re-treatment = 2 | 15 Participants |
| Sham With Ranibizumab | Number of Participants With Re-treatments | Month 6, Frequency of re-treatment = 2 | 3 Participants |
| Sham With Ranibizumab | Number of Participants With Re-treatments | Month 6, Frequency of re-treatment = 1 | 15 Participants |
| Sham With Ranibizumab | Number of Participants With Re-treatments | Month 12, Frequency of re-treatment = 1 | 12 Participants |
| Sham With Ranibizumab | Number of Participants With Re-treatments | Month 12, Frequency of re-treatment = 2 | 7 Participants |
| Sham With Ranibizumab | Number of Participants With Re-treatments | Month 12, Frequency of re-treatment = 3 | 5 Participants |
| Sham With Ranibizumab | Number of Participants With Re-treatments | Month 12, Frequency of re-treatment = 4 | 5 Participants |
| Sham With Ranibizumab | Number of Participants With Re-treatments | Month 12, Frequency of re-treatment = 5 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Re-treatments | Month 12, Frequency of re-treatment = 3 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Re-treatments | Month 6, Frequency of re-treatment = 1 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Re-treatments | Month 12, Frequency of re-treatment = 5 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Re-treatments | Month 12, Frequency of re-treatment = 4 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Re-treatments | Month 12, Frequency of re-treatment = 2 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Re-treatments | Month 12, Frequency of re-treatment = 1 | 0 Participants |
| Sham Without Ranibizumab | Number of Participants With Re-treatments | Month 6, Frequency of re-treatment = 2 | 0 Participants |
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: 12 months
Population: The safety set was used for this analysis. The safety set included randomized participants who received at least one dose of study treatment. Two participants from the sham group were included in the ranibizumab group based on the actual treatment received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab | Number of Primary Reasons for Decision to Treat by Investigator | Vision impairment | 38 Number of primary reasons |
| Ranibizumab | Number of Primary Reasons for Decision to Treat by Investigator | OCT abnormality | 637 Number of primary reasons |
| Ranibizumab | Number of Primary Reasons for Decision to Treat by Investigator | FA abnormality | 11 Number of primary reasons |
| Ranibizumab | Number of Primary Reasons for Decision to Treat by Investigator | Color fundus photography abnormality | 0 Number of primary reasons |
| Ranibizumab | Number of Primary Reasons for Decision to Treat by Investigator | Clinical abnormality | 3 Number of primary reasons |
| Ranibizumab | Number of Primary Reasons for Decision to Treat by Investigator | Without documentation (missing reason) | 0 Number of primary reasons |
| Sham With Ranibizumab | Number of Primary Reasons for Decision to Treat by Investigator | Without documentation (missing reason) | 0 Number of primary reasons |
| Sham With Ranibizumab | Number of Primary Reasons for Decision to Treat by Investigator | Vision impairment | 22 Number of primary reasons |
| Sham With Ranibizumab | Number of Primary Reasons for Decision to Treat by Investigator | Color fundus photography abnormality | 0 Number of primary reasons |
| Sham With Ranibizumab | Number of Primary Reasons for Decision to Treat by Investigator | Clinical abnormality | 0 Number of primary reasons |
| Sham With Ranibizumab | Number of Primary Reasons for Decision to Treat by Investigator | OCT abnormality | 345 Number of primary reasons |
| Sham With Ranibizumab | Number of Primary Reasons for Decision to Treat by Investigator | FA abnormality | 5 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 (missing reason) | 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 |