Macular Edema Secondary to Branch Retinal Vein Occlusion
Conditions
Keywords
BRVO, macular edema, vision impairment, retinal vein occlusion, ranibizumab, branch retinal vein occlusion, anti-VEGF therapy, RFB002
Brief summary
Provided efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to BRVO
Interventions
intravitreal injection of 0.05 ml
OTHERSham injection
Sham intravitreal injection
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Patients with visual impairment secondary to branch retinal vein occlusion (BRVO) with a BCVA between 19 and 73 letters in one eye and at least 35 letters in the other eye.
Exclusion criteria
* Pregnant or nursing women or women of child bearing potential without unless using an effective contraception * Stroke or myocard infarction within 3 months prior to study * History of malignancy within the past 5 years * Uncontrolled hypertension * Active infection or inflammation in any eye * use of corticosteroids for at least 30 days in the last 6 months * treatment with anti-angiogenic drugs in any eye within last 3 months * Panretinal or focal/drid laser photocoagulation within the last few months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 6 | Baseline to Month 1 through Month 6 | Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 6 and compared to Baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Corrected Visual Acuity (BCVA) Change Over Time | Month 1 through Month 12 | Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline |
| Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Baseline to month 12 | Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters |
| Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye | Baseline to 12 months | Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline. |
| Change in Central-Sub-Field- Thickness (CSFT) Over Time | Month 1 to month 12 | OCT (optical coherence tomography) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center |
| Average Change of Best Corrected Visual Acuity (BCVA) in Patients From Baseline to Month 1 Through Month 12 | Baseline to Month 1 through Month 12 | Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline |
| Change in Total Area of Fluorescein Leakage (Inner Subfield) From Baseline Over Time | Months 3, 6 and 12 | Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes |
| Change in Total Area of Fluorescein Leakage (Outer Subfield) From Baseline Over Time | Months 3, 6 and 12 | Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes |
| Change From Baseline in NEI-VFQ-25 Composite and Subscale Scores at Month 3, Month 6 and Month 12 | Baseline, months 3, 6 and 12 | The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning. |
| Change in Total Area of Fluorescein Leakage (Center Subfield) From Baseline Over Time | month 3, 6 and 12 | Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes |
Countries
China, Hong Kong, Indonesia, Philippines, Taiwan, Vietnam
Participant flow
Pre-assignment details
This study consisted of the following three periods (Screening period: Day -14 to Day -1; treatment period: Day 1 to Month 11; post-treatment Follow-Up period: Month 11 to Month 12). At Baseline (Visit 2, Day 1), eligible patients were randomized in a 2:1 ratio into respective treatment arms
Participants by arm
| Arm | Count |
|---|---|
| Ranibizumab 0.5 mg PRN Intravitreal injection | 190 |
| Sham Injection As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection | 93 |
| Total | 283 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 1 |
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 2 |
Baseline characteristics
| Characteristic | Ranibizumab 0.5 mg | Sham Injection | Total |
|---|---|---|---|
| Age, Continuous | 57.0 Years STANDARD_DEVIATION 10.14 | 56.8 Years STANDARD_DEVIATION 10.03 | 56.9 Years STANDARD_DEVIATION 10.09 |
| Sex: Female, Male Female | 101 Participants | 38 Participants | 139 Participants |
| Sex: Female, Male Male | 89 Participants | 55 Participants | 144 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 | 119 / 190 | 46 / 66 | 14 / 26 |
| serious Total, serious adverse events | 13 / 190 | 3 / 66 | 3 / 26 |
Outcome results
Primary
Average Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 6
Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 6 and compared to Baseline.
Time frame: Baseline to Month 1 through Month 6
Population: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab 0.5 mg | Average Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 6 | 12.5 Letters | Standard Deviation 8.34 |
| Sham Injection | Average Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 6 | 5.0 Letters | Standard Deviation 9.18 |
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Average Change of Best Corrected Visual Acuity (BCVA) in Patients From Baseline to Month 1 Through Month 12
Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline
Time frame: Baseline to Month 1 through Month 12
Population: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab 0.5 mg | Average Change of Best Corrected Visual Acuity (BCVA) in Patients From Baseline to Month 1 Through Month 12 | 14.0 Letters | Standard Deviation 8.99 |
| Sham Injection | Average Change of Best Corrected Visual Acuity (BCVA) in Patients From Baseline to Month 1 Through Month 12 | 7.7 Letters | Standard Deviation 9.41 |
Secondary
Best Corrected Visual Acuity (BCVA) Change Over Time
Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline
Time frame: Month 1 through Month 12
Population: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab 0.5 mg | Best Corrected Visual Acuity (BCVA) Change Over Time | Month 5 | 13.6 Letters | Standard Deviation 10.24 |
| Ranibizumab 0.5 mg | Best Corrected Visual Acuity (BCVA) Change Over Time | Month 9 | 14.8 Letters | Standard Deviation 10.43 |
| Ranibizumab 0.5 mg | Best Corrected Visual Acuity (BCVA) Change Over Time | Month 1 | 9.5 Letters | Standard Deviation 8.26 |
| Ranibizumab 0.5 mg | Best Corrected Visual Acuity (BCVA) Change Over Time | Month 2 | 11.7 Letters | Standard Deviation 8.39 |
| Ranibizumab 0.5 mg | Best Corrected Visual Acuity (BCVA) Change Over Time | Month 3 | 12.9 Letters | Standard Deviation 8.81 |
| Ranibizumab 0.5 mg | Best Corrected Visual Acuity (BCVA) Change Over Time | Month 4 | 13.4 Letters | Standard Deviation 9.72 |
| Ranibizumab 0.5 mg | Best Corrected Visual Acuity (BCVA) Change Over Time | Month 6 | 14.0 Letters | Standard Deviation 10.75 |
| Ranibizumab 0.5 mg | Best Corrected Visual Acuity (BCVA) Change Over Time | Month 7 | 14.7 Letters | Standard Deviation 10.62 |
| Ranibizumab 0.5 mg | Best Corrected Visual Acuity (BCVA) Change Over Time | Month 8 | 14.9 Letters | Standard Deviation 10.52 |
| Ranibizumab 0.5 mg | Best Corrected Visual Acuity (BCVA) Change Over Time | Month 10 | 15.8 Letters | Standard Deviation 10.67 |
| Ranibizumab 0.5 mg | Best Corrected Visual Acuity (BCVA) Change Over Time | Month 11 | 15.8 Letters | Standard Deviation 10.42 |
| Ranibizumab 0.5 mg | Best Corrected Visual Acuity (BCVA) Change Over Time | Month 12 | 16.4 Letters | Standard Deviation 10.95 |
| Sham Injection | Best Corrected Visual Acuity (BCVA) Change Over Time | Month 11 | 11.1 Letters | Standard Deviation 10.48 |
| Sham Injection | Best Corrected Visual Acuity (BCVA) Change Over Time | Month 5 | 6.5 Letters | Standard Deviation 11.53 |
| Sham Injection | Best Corrected Visual Acuity (BCVA) Change Over Time | Month 6 | 7.0 Letters | Standard Deviation 12.75 |
| Sham Injection | Best Corrected Visual Acuity (BCVA) Change Over Time | Month 9 | 10.3 Letters | Standard Deviation 10.78 |
| Sham Injection | Best Corrected Visual Acuity (BCVA) Change Over Time | Month 10 | 11.2 Letters | Standard Deviation 11.12 |
| Sham Injection | Best Corrected Visual Acuity (BCVA) Change Over Time | Month 1 | 1.7 Letters | Standard Deviation 8.7 |
| Sham Injection | Best Corrected Visual Acuity (BCVA) Change Over Time | Month 7 | 8.5 Letters | Standard Deviation 10.97 |
| Sham Injection | Best Corrected Visual Acuity (BCVA) Change Over Time | Month 2 | 3.7 Letters | Standard Deviation 8.81 |
| Sham Injection | Best Corrected Visual Acuity (BCVA) Change Over Time | Month 12 | 11.3 Letters | Standard Deviation 11.11 |
| Sham Injection | Best Corrected Visual Acuity (BCVA) Change Over Time | Month 3 | 5.1 Letters | Standard Deviation 10.1 |
| Sham Injection | Best Corrected Visual Acuity (BCVA) Change Over Time | Month 8 | 10.4 Letters | Standard Deviation 10.97 |
| Sham Injection | Best Corrected Visual Acuity (BCVA) Change Over Time | Month 4 | 6.0 Letters | Standard Deviation 10.44 |
Secondary
Change From Baseline in NEI-VFQ-25 Composite and Subscale Scores at Month 3, Month 6 and Month 12
The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning.
Time frame: Baseline, months 3, 6 and 12
Population: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. n=the number of patients with a value for both baseline and the specific post-baseline visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab 0.5 mg | Change From Baseline in NEI-VFQ-25 Composite and Subscale Scores at Month 3, Month 6 and Month 12 | Change from Baseline at M3 (n=187,91) | 5.8 Scores on a Scale | Standard Deviation 10.85 |
| Ranibizumab 0.5 mg | Change From Baseline in NEI-VFQ-25 Composite and Subscale Scores at Month 3, Month 6 and Month 12 | Change from Baseline at M6 (n=185,88) | 7.7 Scores on a Scale | Standard Deviation 11.88 |
| Ranibizumab 0.5 mg | Change From Baseline in NEI-VFQ-25 Composite and Subscale Scores at Month 3, Month 6 and Month 12 | Change from Baseline at M12 (n=176,88) | 9.6 Scores on a Scale | Standard Deviation 13.45 |
| Sham Injection | Change From Baseline in NEI-VFQ-25 Composite and Subscale Scores at Month 3, Month 6 and Month 12 | Change from Baseline at M12 (n=176,88) | 3.3 Scores on a Scale | Standard Deviation 13.52 |
| Sham Injection | Change From Baseline in NEI-VFQ-25 Composite and Subscale Scores at Month 3, Month 6 and Month 12 | Change from Baseline at M3 (n=187,91) | -1.1 Scores on a Scale | Standard Deviation 11.21 |
| Sham Injection | Change From Baseline in NEI-VFQ-25 Composite and Subscale Scores at Month 3, Month 6 and Month 12 | Change from Baseline at M6 (n=185,88) | 0.1 Scores on a Scale | Standard Deviation 13.95 |
Secondary
Change in Central-Sub-Field- Thickness (CSFT) Over Time
OCT (optical coherence tomography) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center
Time frame: Month 1 to month 12
Population: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab 0.5 mg | Change in Central-Sub-Field- Thickness (CSFT) Over Time | Month 10 | -268.4 µm | Standard Deviation 173.71 |
| Ranibizumab 0.5 mg | Change in Central-Sub-Field- Thickness (CSFT) Over Time | Month 1 | -261.1 µm | Standard Deviation 171.95 |
| Ranibizumab 0.5 mg | Change in Central-Sub-Field- Thickness (CSFT) Over Time | Month 2 | -274.8 µm | Standard Deviation 174.17 |
| Ranibizumab 0.5 mg | Change in Central-Sub-Field- Thickness (CSFT) Over Time | Month 3 | -282.2 µm | Standard Deviation 175.86 |
| Ranibizumab 0.5 mg | Change in Central-Sub-Field- Thickness (CSFT) Over Time | Month 4 | -254.7 µm | Standard Deviation 183.87 |
| Ranibizumab 0.5 mg | Change in Central-Sub-Field- Thickness (CSFT) Over Time | Month 5 | -258.6 µm | Standard Deviation 180.57 |
| Ranibizumab 0.5 mg | Change in Central-Sub-Field- Thickness (CSFT) Over Time | Month 6 | -264.1 µm | Standard Deviation 168.64 |
| Ranibizumab 0.5 mg | Change in Central-Sub-Field- Thickness (CSFT) Over Time | Month 7 | -265.4 µm | Standard Deviation 179.06 |
| Ranibizumab 0.5 mg | Change in Central-Sub-Field- Thickness (CSFT) Over Time | Month 8 | -263.8 µm | Standard Deviation 179.38 |
| Ranibizumab 0.5 mg | Change in Central-Sub-Field- Thickness (CSFT) Over Time | Month 9 | -266.7 µm | Standard Deviation 182.6 |
| Ranibizumab 0.5 mg | Change in Central-Sub-Field- Thickness (CSFT) Over Time | Month 11 | -270.6 µm | Standard Deviation 184.34 |
| Ranibizumab 0.5 mg | Change in Central-Sub-Field- Thickness (CSFT) Over Time | Month 12 | -273.4 µm | Standard Deviation 184.33 |
| Sham Injection | Change in Central-Sub-Field- Thickness (CSFT) Over Time | Month 11 | -290.3 µm | Standard Deviation 227.47 |
| Sham Injection | Change in Central-Sub-Field- Thickness (CSFT) Over Time | Month 10 | -282.9 µm | Standard Deviation 239.98 |
| Sham Injection | Change in Central-Sub-Field- Thickness (CSFT) Over Time | Month 6 | -206.6 µm | Standard Deviation 221.85 |
| Sham Injection | Change in Central-Sub-Field- Thickness (CSFT) Over Time | Month 1 | -42.4 µm | Standard Deviation 171.88 |
| Sham Injection | Change in Central-Sub-Field- Thickness (CSFT) Over Time | Month 9 | -287.9 µm | Standard Deviation 237.61 |
| Sham Injection | Change in Central-Sub-Field- Thickness (CSFT) Over Time | Month 2 | -93.1 µm | Standard Deviation 187.14 |
| Sham Injection | Change in Central-Sub-Field- Thickness (CSFT) Over Time | Month 7 | -289.8 µm | Standard Deviation 228.03 |
| Sham Injection | Change in Central-Sub-Field- Thickness (CSFT) Over Time | Month 3 | -155.3 µm | Standard Deviation 209.37 |
| Sham Injection | Change in Central-Sub-Field- Thickness (CSFT) Over Time | Month 12 | -282.9 µm | Standard Deviation 233.69 |
| Sham Injection | Change in Central-Sub-Field- Thickness (CSFT) Over Time | Month 4 | -193.2 µm | Standard Deviation 221.58 |
| Sham Injection | Change in Central-Sub-Field- Thickness (CSFT) Over Time | Month 8 | -286.1 µm | Standard Deviation 236.75 |
| Sham Injection | Change in Central-Sub-Field- Thickness (CSFT) Over Time | Month 5 | -203.2 µm | Standard Deviation 218.02 |
Secondary
Change in Total Area of Fluorescein Leakage (Center Subfield) From Baseline Over Time
Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes
Time frame: month 3, 6 and 12
Population: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab 0.5 mg | Change in Total Area of Fluorescein Leakage (Center Subfield) From Baseline Over Time | Month 3 | -0.400 mm^2 | Standard Deviation 0.3576 |
| Ranibizumab 0.5 mg | Change in Total Area of Fluorescein Leakage (Center Subfield) From Baseline Over Time | Month 6 | -0.356 mm^2 | Standard Deviation 0.3983 |
| Ranibizumab 0.5 mg | Change in Total Area of Fluorescein Leakage (Center Subfield) From Baseline Over Time | Month 12 | -0.391 mm^2 | Standard Deviation 0.3716 |
| Sham Injection | Change in Total Area of Fluorescein Leakage (Center Subfield) From Baseline Over Time | Month 12 | -.0208 mm^2 | Standard Deviation 0.4075 |
| Sham Injection | Change in Total Area of Fluorescein Leakage (Center Subfield) From Baseline Over Time | Month 3 | -0.026 mm^2 | Standard Deviation 0.3387 |
| Sham Injection | Change in Total Area of Fluorescein Leakage (Center Subfield) From Baseline Over Time | Month 6 | -0.055 mm^2 | Standard Deviation 0.406 |
Secondary
Change in Total Area of Fluorescein Leakage (Inner Subfield) From Baseline Over Time
Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes
Time frame: Months 3, 6 and 12
Population: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab 0.5 mg | Change in Total Area of Fluorescein Leakage (Inner Subfield) From Baseline Over Time | Month 3 | -1.869 mm^2 | Standard Deviation 1.8071 |
| Ranibizumab 0.5 mg | Change in Total Area of Fluorescein Leakage (Inner Subfield) From Baseline Over Time | Month 6 | -1.642 mm^2 | Standard Deviation 1.957 |
| Ranibizumab 0.5 mg | Change in Total Area of Fluorescein Leakage (Inner Subfield) From Baseline Over Time | Month 12 | -1.732 mm^2 | Standard Deviation 1.8059 |
| Sham Injection | Change in Total Area of Fluorescein Leakage (Inner Subfield) From Baseline Over Time | Month 3 | 0.111 mm^2 | Standard Deviation 1.5497 |
| Sham Injection | Change in Total Area of Fluorescein Leakage (Inner Subfield) From Baseline Over Time | Month 6 | -0.078 mm^2 | Standard Deviation 1.6856 |
| Sham Injection | Change in Total Area of Fluorescein Leakage (Inner Subfield) From Baseline Over Time | Month 12 | -0.823 mm^2 | Standard Deviation 1.965 |
Secondary
Change in Total Area of Fluorescein Leakage (Outer Subfield) From Baseline Over Time
Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes
Time frame: Months 3, 6 and 12
Population: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab 0.5 mg | Change in Total Area of Fluorescein Leakage (Outer Subfield) From Baseline Over Time | Month 6 | -4.654 mm^2 | Standard Deviation 5.7504 |
| Ranibizumab 0.5 mg | Change in Total Area of Fluorescein Leakage (Outer Subfield) From Baseline Over Time | Month 3 | -4.994 mm^2 | Standard Deviation 5.4066 |
| Ranibizumab 0.5 mg | Change in Total Area of Fluorescein Leakage (Outer Subfield) From Baseline Over Time | Month 12 | -5.078 mm^2 | Standard Deviation 5.9568 |
| Sham Injection | Change in Total Area of Fluorescein Leakage (Outer Subfield) From Baseline Over Time | Month 3 | -0.600 mm^2 | Standard Deviation 3.6646 |
| Sham Injection | Change in Total Area of Fluorescein Leakage (Outer Subfield) From Baseline Over Time | Month 6 | -0.836 mm^2 | Standard Deviation 4.2819 |
| Sham Injection | Change in Total Area of Fluorescein Leakage (Outer Subfield) From Baseline Over Time | Month 12 | -2.797 mm^2 | Standard Deviation 5.3702 |
Secondary
Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time
Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters
Time frame: Baseline to month 12
Population: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 8 Gain of >=15 letters | 94 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 2 Gain of >=15 letters | 72 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 3 Gain of >=30 letters | 8 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 4 Gain of >=5 letters | 159 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 4 Gain of >=10 letters | 122 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 4 Gain of >=15 letters | 83 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 4 Gain of >=30 letters | 11 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 5 Gain of >=5 letters | 159 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 5 Gain of >=10 letters | 127 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 5 Gain of >=15 letters | 83 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 5 Gain of >=30 letters | 15 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 6 Gain of >=30 letters | 16 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 7 Gain of >=5 letters | 162 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 8 Gain of >=150 letters | 130 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 8 Gain of >=30 letters | 17 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 9 Gain of >=15 letters | 90 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 10 Gain of >=5 letters | 169 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 11 Gain of >=30 letters | 19 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 12 Gain of >=5 letters | 171 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 1 Gain of >=5 letters | 139 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 1 Gain of >=10 letters | 86 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 1 Gain of >=15 letters | 43 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 1 Gain of >=30 letters | 2 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 2 Gain of >=5 letters | 156 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 2 Gain of >=10 letters | 113 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 2 Gain of >=30 letters | 6 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 3 Gain of >=5 letters | 162 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 3 Gain of >=10 letters | 116 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 3 Gain of >=15 letters | 76 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 6 Gain of >=5 letters | 163 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 6 Gain of >=10 letters | 129 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 6 Gain of >=15 letters | 88 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 7 Gain of >=10 letters | 135 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 7 Gain of >=15 letters | 93 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 7 Gain of >=30 letters | 16 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 8 Gain of >=5 letters | 168 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 9 Gain of >=5 letters | 163 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 9 Gain of >=10 letters | 139 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 9 Gain of >=30 letters | 17 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 10 Gain of >=10 letters | 143 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 10 Gain of >=15 letters | 97 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 10 Gain of >=30 letters | 22 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 11 Gain of >=5 letters | 172 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 11 Gain of >=10 letters | 141 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 11 Gain of >=15 letters | 103 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 12 Gain of >=10 letters | 142 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 12 Gain of >=15 letters | 105 Participants |
| Ranibizumab 0.5 mg | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 12 Gain of >=30 letters | 24 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 12 Gain of >=5 letters | 72 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 2 Gain of >=30 letters | 2 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 9 Gain of >=5 letters | 67 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 3 Gain of >=30 letters | 0 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 3 Gain of >=5 letters | 49 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 4 Gain of >=5 letters | 55 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 11 Gain of >=5 letters | 67 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 4 Gain of >=10 letters | 32 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 3 Gain of >=10 letters | 29 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 9 Gain of >=10 letters | 52 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 4 Gain of >=30 letters | 2 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 3 Gain of >=15 letters | 16 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 4 Gain of >=15 letters | 16 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 5 Gain of >=10 letters | 40 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 5 Gain of >=5 letters | 60 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 5 Gain of >=15 letters | 19 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 12 Gain of >=15 letters | 36 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 5 Gain of >=30 letters | 2 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 6 Gain of >=15 letters | 25 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 6 Gain of >=5 letters | 58 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 6 Gain of >=30 letters | 3 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 9 Gain of >=30 letters | 4 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 6 Gain of >=10 letters | 47 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 8 Gain of >=150 letters | 52 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 2 Gain of >=10 letters | 21 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 8 Gain of >=15 letters | 33 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 11 Gain of >=10 letters | 56 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 7 Gain of >=5 letters | 63 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 9 Gain of >=15 letters | 32 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 12 Gain of >=10 letters | 56 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 10 Gain of >=5 letters | 68 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 10 Gain of >=10 letters | 53 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 7 Gain of >=10 letters | 49 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 11 Gain of >=30 letters | 4 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 10 Gain of >=15 letters | 37 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 12 Gain of >=30 letters | 5 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 7 Gain of >=15 letters | 28 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 1 Gain of >=5 letters | 33 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 11 Gain of >=15 letters | 36 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 1 Gain of >=10 letters | 12 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 7 Gain of >=30 letters | 3 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 1 Gain of >=15 letters | 3 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 10 Gain of >=30 letters | 7 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 1 Gain of >=30 letters | 0 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 8 Gain of >=5 letters | 66 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 2 Gain of >=5 letters | 44 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 8 Gain of >=30 letters | 4 Participants |
| Sham Injection | Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time | Month 2 Gain of >=15 letters | 6 Participants |
Secondary
Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye
Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline.
Time frame: Baseline to 12 months
Population: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab 0.5 mg | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye | Month 7, Loss of < 15 letters | 188 Participants |
| Ranibizumab 0.5 mg | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye | Month 2, Loss of < 15 letters | 189 Participants |
| Ranibizumab 0.5 mg | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye | Month 3, Loss of < 15 letters | 189 Participants |
| Ranibizumab 0.5 mg | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye | Month 8, Loss of < 15 letters | 188 Participants |
| Ranibizumab 0.5 mg | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye | Month 9, Loss of < 15 letters | 187 Participants |
| Ranibizumab 0.5 mg | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye | Month 10, Loss of < 15 letters | 188 Participants |
| Ranibizumab 0.5 mg | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye | Month 11, Loss of < 15 letters | 187 Participants |
| Ranibizumab 0.5 mg | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye | Month 12, Loss of < 15 letters | 187 Participants |
| Ranibizumab 0.5 mg | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye | Month 1, Loss of < 15 letters | 188 Participants |
| Ranibizumab 0.5 mg | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye | Month 4, Loss of < 15 letters | 189 Participants |
| Ranibizumab 0.5 mg | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye | Month 5, Loss of < 15 letters | 189 Participants |
| Ranibizumab 0.5 mg | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye | Month 6, Loss of < 15 letters | 188 Participants |
| Sham Injection | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye | Month 12, Loss of < 15 letters | 91 Participants |
| Sham Injection | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye | Month 10, Loss of < 15 letters | 92 Participants |
| Sham Injection | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye | Month 2, Loss of < 15 letters | 90 Participants |
| Sham Injection | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye | Month 1, Loss of < 15 letters | 89 Participants |
| Sham Injection | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye | Month 4, Loss of < 15 letters | 88 Participants |
| Sham Injection | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye | Month 5, Loss of < 15 letters | 88 Participants |
| Sham Injection | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye | Month 6, Loss of < 15 letters | 89 Participants |
| Sham Injection | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye | Month 9, Loss of < 15 letters | 93 Participants |
| Sham Injection | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye | Month 7, Loss of < 15 letters | 91 Participants |
| Sham Injection | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye | Month 11, Loss of < 15 letters | 93 Participants |
| Sham Injection | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye | Month 8, Loss of < 15 letters | 92 Participants |
| Sham Injection | Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye | Month 3, Loss of < 15 letters | 88 Participants |