Neovascular Age-related Macular Degeneration
Conditions
Keywords
Macular degeneration,, age-related macular degeneration (ARMD),, vision loss,, macula damage,, retina damage,, dry macular degeneration,, wet macular degeneration,, AMD
Brief summary
The study evaluated the efficacy and safety of two different dosing regimens of ranibizumab (either monthly injections or injections as-needed based on the stability of a patient's vision) in Chinese patients with wet age-related macular degeneration (AMD) . This study was to provide long-term safety data in the treatment of Chinese patients with wet AMD.
Interventions
DRUGRanibizumab
Intravitreal injections of 0.5 mg Ranibizumab
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion criteria: * Patients with visual impairment due to neovascular AMD * A qualifying vision score at study entry Key
Exclusion criteria
* Active infection or inflammation either eye at study entry * Uncontrolled glaucoma in either eye * Any disorder in the study eye which may affect vision * Use of any systemic anti-vascular endothelial growth factor (VEGF)-drugs within 3 months prior to study entry * Previous treatment of the study eye for wet AMD * Any surgery in the study eye 3 months prior to or planned with 6 month after study entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Change in Visual Acuity (Letters) From Month 3 to Month 4 Through Month 12 | Month 3 to month 4 through Month 12 | 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 VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the VA averaged across all visits from Month 4 through 12 and the Month 3 Level of Visual Acuity (Letters) of the Study Eye. The treatment regimen up to Month 3 is the same in both treatment groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and Month 1 Through Month 24 | Baseline to Month 24 | 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 the difference between VA averaged across all visits from Month 1 through Month 12 (24) and the baseline VA level |
| Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Baseline to 24 months | Visual acuity (VA) was assessed on both eyes during 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 the change in visual acuity at each visit compared to baseline |
| Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Baseline to Month 24 | Visual acuity (VA) was 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 improved by equal or more than 5, 10, 15,or 30 letters of VA as compared to baseline. |
| Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Baseline to Month 24 | 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. |
| Number of Patients With a Best Corrected Visual Acuity (BCVA) of More of 73 Letters or More | Month 12 and 24 | 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 Month 12 and Month 24 whether a patient had a VA score of 73 or more letters |
| Average Visual Acuity Change (Letters) From Month 3 to Month 4 Through Month 24 | Month 3 to month 4 through Month 24 | 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 the difference between the average level of VA over all monthly post-baseline assessments from Month 4 to Month 24 and the Month 3 Level of VA. The treatment regimen up to Month 3 is the same in both treatment groups. |
| Duration of Ranibizumab Treatment Free Interval in the Study Eye up to Month 24 | up to month 24 | This outcome measure describes duration of treatment-free intervals. Treatment-free interval is defined as the number of visits (whether attended or not) where ranibizumab was not administered. n= the number of patients who had at least one ranibizumab treatment interruption |
| Duration of Ranibizumab Treatment Free Interval in the Study Eye Prior to Month 12 | prior to month 12 | This outcome measure describes duration of treatment-free intervals prior to month 12. Treatment-free interval is defined as the number of visits (whether attended or not) where ranibizumab was not administered. n= the number of patients who had at least one ranibizumab treatment interruption Treatment-free interval is analyzed in the Ranibizumab 0.5 mg PRN group only. It is not analyzed in the Ranibizumab 0.5 mg monthly group because, by protocol design, these participants receive treatment monthly. Therefore, the analysis does not apply to this group. |
| Duration of Active Treatment Phase Prior to Month 12 | Prior to month 12 | — |
| Duration of Active Treatment Phase up to Month 24 | up to month 24 | — |
| Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Baseline to Month 24 | Optical coherence tomography(OCT) 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. The Ns in the rows is the number of patients with a value for both baseline and the specific post-baseline visit |
Countries
China
Participant flow
Pre-assignment details
A total of 334 patients were randomized in this study. One patient was mis-randomized to ranibizumab 0.5 monthly group and another patient was discontinued due to AE. Neither patient received any treatment
Participants by arm
| Arm | Count |
|---|---|
| Ranibizumab 0.5 mg Monthly Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period | 167 |
| Ranibizumab 0.5 mg PRN PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period | 166 |
| Total | 333 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Core Period | Administrative problems | 1 | 0 |
| Core Period | Adverse Event | 5 | 5 |
| Core Period | Death | 0 | 1 |
| Core Period | Disease Progression | 0 | 1 |
| Core Period | Physician Decision | 1 | 1 |
| Core Period | Withdrawal by Subject | 4 | 2 |
| Extension Period | Administrative problems | 0 | 1 |
| Extension Period | Adverse Event | 3 | 2 |
| Extension Period | Lost to Follow-up | 0 | 1 |
| Extension Period | Physician Decision | 0 | 2 |
| Extension Period | Withdrawal by Subject | 9 | 12 |
Baseline characteristics
| Characteristic | Ranibizumab 0.5 mg Monthly | Ranibizumab 0.5 mg PRN | Total |
|---|---|---|---|
| Age, Continuous | 65.6 Years STANDARD_DEVIATION 8.43 | 66.8 Years STANDARD_DEVIATION 8.31 | 66.2 Years STANDARD_DEVIATION 8.38 |
| Sex: Female, Male Female | 48 Participants | 47 Participants | 95 Participants |
| Sex: Female, Male Male | 119 Participants | 119 Participants | 238 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 107 / 166 | 87 / 166 |
| serious Total, serious adverse events | 24 / 166 | 24 / 166 |
Outcome results
Primary
Average Change in Visual Acuity (Letters) From Month 3 to Month 4 Through Month 12
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 VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the VA averaged across all visits from Month 4 through 12 and the Month 3 Level of Visual Acuity (Letters) of the Study Eye. The treatment regimen up to Month 3 is the same in both treatment groups.
Time frame: Month 3 to month 4 through Month 12
Population: Full Analysis Set: Consisted of all patients to whom study treatment was assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab 0.5 mg Monthly | Average Change in Visual Acuity (Letters) From Month 3 to Month 4 Through Month 12 | 3.3 Letters | Standard Deviation 5.61 |
| Ranibizumab 0.5 mg PRN | Average Change in Visual Acuity (Letters) From Month 3 to Month 4 Through Month 12 | 1.7 Letters | Standard Deviation 6.87 |
Comparison: Descriptive, no hypothesis95% CI: [-2.95, -0.2]ANOVA
Secondary
Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and Month 1 Through Month 24
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 the difference between VA averaged across all visits from Month 1 through Month 12 (24) and the baseline VA level
Time frame: Baseline to Month 24
Population: Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab 0.5 mg Monthly | Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and Month 1 Through Month 24 | Average Month 1 through month 12 | 10.1 Letters | Standard Deviation 9.37 |
| Ranibizumab 0.5 mg Monthly | Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and Month 1 Through Month 24 | Average Month 1 through month 24 | 11.0 Letters | Standard Deviation 10.28 |
| Ranibizumab 0.5 mg PRN | Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and Month 1 Through Month 24 | Average Month 1 through month 12 | 8.1 Letters | Standard Deviation 10.95 |
| Ranibizumab 0.5 mg PRN | Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and Month 1 Through Month 24 | Average Month 1 through month 24 | 8.9 Letters | Standard Deviation 11.95 |
Secondary
Average Visual Acuity Change (Letters) From Month 3 to Month 4 Through Month 24
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 the difference between the average level of VA over all monthly post-baseline assessments from Month 4 to Month 24 and the Month 3 Level of VA. The treatment regimen up to Month 3 is the same in both treatment groups.
Time frame: Month 3 to month 4 through Month 24
Population: Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab 0.5 mg Monthly | Average Visual Acuity Change (Letters) From Month 3 to Month 4 Through Month 24 | 3.7 Letters | Standard Deviation 7.36 |
| Ranibizumab 0.5 mg PRN | Average Visual Acuity Change (Letters) From Month 3 to Month 4 Through Month 24 | 2.2 Letters | Standard Deviation 7.95 |
Secondary
Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24
Optical coherence tomography(OCT) 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. The Ns in the rows is the number of patients with a value for both baseline and the specific post-baseline visit
Time frame: Baseline to Month 24
Population: Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (LOCF)= last observation carried forward
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 9 | -165.1 microns | Standard Deviation 136.04 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 3 | -141.3 microns | Standard Deviation 127.47 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 4 | -150.4 microns | Standard Deviation 131.71 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 6 | -158.6 microns | Standard Deviation 135.37 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 8 | -165.4 microns | Standard Deviation 135.59 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 2 | -141.1 microns | Standard Deviation 126.44 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 10 | -165.9 microns | Standard Deviation 136.03 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 11 | -166.6 microns | Standard Deviation 140.62 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 12 | -166.5 microns | Standard Deviation 143.85 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 13 | -160.3 microns | Standard Deviation 142.02 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 16 | -155.9 microns | Standard Deviation 154.82 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 18 | -159.5 microns | Standard Deviation 159.78 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 19 | -158.5 microns | Standard Deviation 163.82 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 23 | -159.4 microns | Standard Deviation 163.58 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 24 | -167.7 microns | Standard Deviation 163.12 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 1 | -112.8 microns | Standard Deviation 117.95 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 5 | -155.2 microns | Standard Deviation 134.58 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 7 | -156.9 microns | Standard Deviation 136.61 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 14 | -159.9 microns | Standard Deviation 144.14 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 15 | -156.9 microns | Standard Deviation 152.33 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 17 | -161.8 microns | Standard Deviation 155.18 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 20 | -157.6 microns | Standard Deviation 161.04 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 21 | -155.2 microns | Standard Deviation 160.03 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 22 | -156.8 microns | Standard Deviation 161.35 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 18 | -156.7 microns | Standard Deviation 174.88 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 2 | -130.4 microns | Standard Deviation 145.58 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 16 | -158.1 microns | Standard Deviation 173.23 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 19 | -154.8 microns | Standard Deviation 177.49 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 4 | -134.5 microns | Standard Deviation 158.88 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 5 | -131.5 microns | Standard Deviation 155.98 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 22 | -146.5 microns | Standard Deviation 176.83 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 6 | -138.3 microns | Standard Deviation 159.07 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 10 | -152.5 microns | Standard Deviation 177.11 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 7 | -137.9 microns | Standard Deviation 165.24 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 20 | -152.1 microns | Standard Deviation 173.3 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 8 | -142.2 microns | Standard Deviation 165.76 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 23 | -148.3 microns | Standard Deviation 185.62 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 9 | -143.3 microns | Standard Deviation 176.68 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 14 | -153.2 microns | Standard Deviation 167.81 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 24 | -153.2 microns | Standard Deviation 178.22 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 11 | -152.5 microns | Standard Deviation 175.56 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 21 | -151.9 microns | Standard Deviation 171.95 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 12 | -155.7 microns | Standard Deviation 173.19 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 1 | -108.7 microns | Standard Deviation 124.93 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 13 | -151.4 microns | Standard Deviation 168.89 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 3 | -141.2 microns | Standard Deviation 161.88 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 17 | -156.8 microns | Standard Deviation 167.89 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 | Month 15 | -158.1 microns | Standard Deviation 169.56 |
Secondary
Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time
Visual acuity (VA) was assessed on both eyes during 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 the change in visual acuity at each visit compared to baseline
Time frame: Baseline to 24 months
Population: Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 7 | 11.4 letters | Standard Deviation 10.49 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 1 | 4.3 letters | Standard Deviation 6.75 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 2 | 6.8 letters | Standard Deviation 8.02 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 3 | 8.0 letters | Standard Deviation 9.38 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 4 | 9.3 letters | Standard Deviation 10.52 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 5 | 9.9 letters | Standard Deviation 10.71 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 6 | 10.7 letters | Standard Deviation 10.92 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 8 | 11.3 letters | Standard Deviation 11.06 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 9 | 11.8 letters | Standard Deviation 10.9 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 10 | 12.4 letters | Standard Deviation 11.24 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 11 | 12.5 letters | Standard Deviation 10.9 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 12 | 12.3 letters | Standard Deviation 11.47 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 13 | 12.2 letters | Standard Deviation 12.04 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 14 | 12.1 letters | Standard Deviation 12.18 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 15 | 12.2 letters | Standard Deviation 12.19 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 16 | 12.3 letters | Standard Deviation 11.59 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 17 | 12.1 letters | Standard Deviation 11.94 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 18 | 11.8 letters | Standard Deviation 12.31 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 19 | 12.1 letters | Standard Deviation 12.43 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 20 | 12.1 letters | Standard Deviation 12.7 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 21 | 11.9 letters | Standard Deviation 13.17 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 22 | 11.3 letters | Standard Deviation 13.19 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 23 | 11.5 letters | Standard Deviation 13.23 |
| Ranibizumab 0.5 mg Monthly | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 24 | 11.3 letters | Standard Deviation 13.72 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 23 | 9.2 letters | Standard Deviation 15.13 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 13 | 9.9 letters | Standard Deviation 12.98 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 1 | 3.4 letters | Standard Deviation 8.74 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 19 | 9.8 letters | Standard Deviation 14.54 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 2 | 6.3 letters | Standard Deviation 9.94 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 14 | 10.0 letters | Standard Deviation 13.29 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 22 | 9.5 letters | Standard Deviation 15.26 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 4 | 7.9 letters | Standard Deviation 11.67 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 15 | 9.9 letters | Standard Deviation 13.56 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 5 | 8.4 letters | Standard Deviation 11.66 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 20 | 9.8 letters | Standard Deviation 14.74 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 6 | 8.7 letters | Standard Deviation 12.33 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 3 | 7.2 letters | Standard Deviation 11.48 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 7 | 8.5 letters | Standard Deviation 13.01 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 16 | 10.0 letters | Standard Deviation 13.64 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 8 | 8.8 letters | Standard Deviation 12.53 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 24 | 9.3 letters | Standard Deviation 15.48 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 9 | 9.2 letters | Standard Deviation 12.83 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 17 | 10.4 letters | Standard Deviation 13.78 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 10 | 9.4 letters | Standard Deviation 12.84 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 21 | 9.6 letters | Standard Deviation 14.73 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 11 | 9.6 letters | Standard Deviation 12.89 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 18 | 10.1 letters | Standard Deviation 13.25 |
| Ranibizumab 0.5 mg PRN | Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time | Month 12 | 9.6 letters | Standard Deviation 13.06 |
Secondary
Duration of Active Treatment Phase Prior to Month 12
Time frame: Prior to month 12
Population: Safety set consisted of all patients who received at least one application of ranibizumab ( active study treatment) and had at least one post-baseline safety assessment. A patient who had no AEs also constituted a safety assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab 0.5 mg Monthly | Duration of Active Treatment Phase Prior to Month 12 | 10.5 Months | Standard Deviation 1.86 |
| Ranibizumab 0.5 mg PRN | Duration of Active Treatment Phase Prior to Month 12 | 9.1 Months | Standard Deviation 2.76 |
Secondary
Duration of Active Treatment Phase up to Month 24
Time frame: up to month 24
Population: Safety set consisted of all patients who received at least one application of ranibizumab ( active study treatment) and had at least one post-baseline safety assessment. A patient who had no AEs also constituted a safety assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab 0.5 mg Monthly | Duration of Active Treatment Phase up to Month 24 | 18.0 Months | Standard Deviation 5.99 |
| Ranibizumab 0.5 mg PRN | Duration of Active Treatment Phase up to Month 24 | 17.1 Months | Standard Deviation 6.9 |
Secondary
Duration of Ranibizumab Treatment Free Interval in the Study Eye Prior to Month 12
This outcome measure describes duration of treatment-free intervals prior to month 12. Treatment-free interval is defined as the number of visits (whether attended or not) where ranibizumab was not administered. n= the number of patients who had at least one ranibizumab treatment interruption Treatment-free interval is analyzed in the Ranibizumab 0.5 mg PRN group only. It is not analyzed in the Ranibizumab 0.5 mg monthly group because, by protocol design, these participants receive treatment monthly. Therefore, the analysis does not apply to this group.
Time frame: prior to month 12
Population: Safety set consisted of all patients who received at least one application of ranibizumab ( active study treatment) and had at least one post-baseline safety assessment. A patient who had no AEs also constituted a safety assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab 0.5 mg Monthly | Duration of Ranibizumab Treatment Free Interval in the Study Eye Prior to Month 12 | First treatment free interval (n=127) | 2.7 Months | Standard Deviation 2.22 |
| Ranibizumab 0.5 mg Monthly | Duration of Ranibizumab Treatment Free Interval in the Study Eye Prior to Month 12 | Second treatment free interval (n=73) | 2.0 Months | Standard Deviation 1.29 |
| Ranibizumab 0.5 mg Monthly | Duration of Ranibizumab Treatment Free Interval in the Study Eye Prior to Month 12 | Third treatment free interval (n=19) | 1.3 Months | Standard Deviation 0.67 |
Secondary
Duration of Ranibizumab Treatment Free Interval in the Study Eye up to Month 24
This outcome measure describes duration of treatment-free intervals. Treatment-free interval is defined as the number of visits (whether attended or not) where ranibizumab was not administered. n= the number of patients who had at least one ranibizumab treatment interruption
Time frame: up to month 24
Population: Safety set consisted of all patients who received at least one application of ranibizumab ( active study treatment) and had at least one post-baseline safety assessment. A patient who had no AEs also constituted a safety assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab 0.5 mg Monthly | Duration of Ranibizumab Treatment Free Interval in the Study Eye up to Month 24 | First treatment free interval (n=99,144) | 2.9 Months | Standard Deviation 2.38 |
| Ranibizumab 0.5 mg Monthly | Duration of Ranibizumab Treatment Free Interval in the Study Eye up to Month 24 | Second treatment free interval (n=49,112) | 2.1 Months | Standard Deviation 1.51 |
| Ranibizumab 0.5 mg Monthly | Duration of Ranibizumab Treatment Free Interval in the Study Eye up to Month 24 | Third treatment free interval (n=12,78) | 1.5 Months | Standard Deviation 0.52 |
| Ranibizumab 0.5 mg PRN | Duration of Ranibizumab Treatment Free Interval in the Study Eye up to Month 24 | Third treatment free interval (n=12,78) | 3.0 Months | Standard Deviation 2.67 |
| Ranibizumab 0.5 mg PRN | Duration of Ranibizumab Treatment Free Interval in the Study Eye up to Month 24 | First treatment free interval (n=99,144) | 3.7 Months | Standard Deviation 4.67 |
| Ranibizumab 0.5 mg PRN | Duration of Ranibizumab Treatment Free Interval in the Study Eye up to Month 24 | Second treatment free interval (n=49,112) | 3.3 Months | Standard Deviation 3.48 |
Secondary
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Visual acuity (VA) was 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 improved by equal or more than 5, 10, 15,or 30 letters of VA as compared to baseline.
Time frame: Baseline to Month 24
Population: Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 12 Gain of >=5 letters | 129 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 12 Gain of >=10 letters | 97 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 12 Gain of >=15 letters | 69 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 12 Gain of >=30 letters | 7 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 13 Gain of >=5 letters | 127 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 13 Gain of >=10 letters | 96 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 13 Gain of >=15 letters | 67 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 13 Gain of >=30 letters | 9 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 14 Gain of >=5 letters | 124 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 14 Gain of >=10 letters | 100 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 14 Gain of >=15 letters | 70 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 14 Gain of >=30 letters | 9 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 15 Gain of >=5 letters | 126 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 15 Gain of >=15 letters | 68 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 15 Gain of >=30 letters | 8 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 16 Gain of >=5 letters | 126 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 16 Gain of >=10 letters | 101 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 16 Gain of >=15 letters | 71 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 17 Gain of >=10 letters | 102 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 17 Gain of >=15 letters | 71 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 17 Gain of >=30 letters | 5 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 18 Gain of >=5 letters | 121 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 18 Gain of >=10 letters | 101 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 18 Gain of >=15 letters | 69 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 18 Gain of >=30 letters | 6 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 19 Gain of >=5 letters | 121 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 19 Gain of >=10 letters | 94 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 19 Gain of >=15 letters | 75 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 19 Gain of >=30 letters | 9 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 20 Gain of >=5 letters | 116 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 20 Gain of >=10 letters | 98 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 20 Gain of >=15 letters | 72 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 20 Gain of >=30 letters | 10 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 21 Gain of >=5 letters | 120 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 21 Gain of >=10 letters | 96 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 21 Gain of >=15 letters | 76 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 21 Gain of >=30 letters | 11 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 22 Gain of >=5 letters | 116 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 22 Gain of >=10 letters | 92 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 22 Gain of >=15 letters | 69 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 22 Gain of >=30 letters | 14 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 23 Gain of >=5 letters | 119 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 23 Gain of >=10 letters | 93 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 23 Gain of >=15 letters | 72 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 23 Gain of >=30 letters | 8 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 24 Gain of >=5 letters | 114 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 24 Gain of >=10 letters | 95 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 24 Gain of >=15 letters | 73 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 24 Gain of >=30 letters | 11 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 1 Gain of >=5 letters | 75 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 1 Gain of >=10 letters | 27 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 1 Gain of >=15 letters | 11 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 1 Gain of >=30 letters | 1 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 2 Gain of >=5 letters | 98 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 2 Gain of >=10 letters | 54 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 2 Gain of >=15 letters | 28 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 2 Gain of >=30 letters | 1 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 3 Gain of >=5 letters | 107 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 3 Gain of >=10 letters | 71 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 3 Gain of >=15 letters | 40 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 3 Gain of >=30 letters | 1 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 4 Gain of >=5 letters | 115 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 4 Gain of >=10 letters | 80 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 4 Gain of >=15 letters | 53 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 4 Gain of >=30 letters | 3 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 5 Gain of >=5 letters | 114 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 5 Gain of >=10 letters | 88 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 5 Gain of >=15 letters | 59 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 5 Gain of >=30 letters | 4 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 6 Gain of >=5 letters | 124 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 6 Gain of >=10 letters | 86 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 6 Gain of >=15 letters | 60 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 6 Gain of >=30 letters | 6 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 7 Gain of >=5 letters | 127 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 7 Gain of >=10 letters | 89 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 7 Gain of >=15 letters | 63 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 7 Gain of >=30 letters | 5 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 8 Gain of >=5 letters | 129 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 8 Gain of >=10 letters | 89 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 8 Gain of >=15 letters | 66 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 8 Gain of >=30 letters | 6 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 9 Gain of >=5 letters | 126 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 9 Gain of >=10 letters | 95 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 9 Gain of >=15 letters | 69 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 9 Gain of >=30 letters | 6 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 10 Gain of >=5 letters | 128 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 10 Gain of >=10 letters | 95 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 10 Gain of >=15 letters | 74 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 10 Gain of >=30 letters | 8 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 11 Gain of >=5 letters | 130 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 11 Gain of >=15 letters | 78 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 11 Gain of >=30 letters | 7 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 11 Gain of >=10 letters | 97 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 15 Gain of >=10 letters | 104 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 16 Gain of >=30 letters | 7 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 17 Gain of >=5 letters | 119 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 7 Gain of >=5 letters | 114 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 12 Gain of >=5 letters | 114 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 1 Gain of >=5 letters | 65 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 12 Gain of >=10 letters | 82 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 18 Gain of >=5 letters | 117 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 12 Gain of >=15 letters | 52 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 1 Gain of >=10 letters | 31 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 12 Gain of >=30 letters | 11 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 7 Gain of >=10 letters | 70 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 13 Gain of >=5 letters | 118 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 1 Gain of >=15 letters | 17 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 13 Gain of >=10 letters | 92 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 10 Gain of >=10 letters | 75 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 1 Gain of >=30 letters | 1 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 13 Gain of >=30 letters | 11 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 7 Gain of >=15 letters | 50 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 14 Gain of >=5 letters | 117 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 2 Gain of >=5 letters | 95 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 14 Gain of >=10 letters | 88 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 11 Gain of >=30 letters | 11 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 14 Gain of >=15 letters | 65 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 2 Gain of >=10 letters | 48 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 14 Gain of >=30 letters | 13 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 7 Gain of >=30 letters | 10 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 15 Gain of >=5 letters | 112 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 15 Gain of >=10 letters | 84 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 2 Gain of >=15 letters | 32 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 15 Gain of >=15 letters | 62 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 10 Gain of >=15 letters | 53 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 15 Gain of >=30 letters | 13 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 2 Gain of >=30 letters | 1 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 16 Gain of >=5 letters | 114 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 8 Gain of >=5 letters | 110 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 3 Gain of >=5 letters | 100 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 16 Gain of >=15 letters | 62 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 16 Gain of >=30 letters | 11 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 17 Gain of >=5 letters | 116 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 13 Gain of >=15 letters | 56 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 3 Gain of >=10 letters | 60 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 8 Gain of >=10 letters | 74 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 17 Gain of >=30 letters | 12 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 3 Gain of >=15 letters | 37 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 10 Gain of >=30 letters | 11 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 18 Gain of >=10 letters | 87 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 3 Gain of >=30 letters | 4 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 18 Gain of >=15 letters | 61 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 8 Gain of >=15 letters | 54 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 18 Gain of >=30 letters | 13 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 4 Gain of >=5 letters | 100 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 19 Gain of >=5 letters | 115 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 17 Gain of >=10 letters | 87 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 19 Gain of >=10 letters | 88 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 4 Gain of >=10 letters | 75 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 19 Gain of >=15 letters | 62 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 8 Gain of >=30 letters | 7 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 19 Gain of >=30 letters | 11 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 4 Gain of >=15 letters | 46 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 20 Gain of >=5 letters | 116 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 11 Gain of >=5 letters | 115 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 20 Gain of >=10 letters | 85 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 4 Gain of >=30 letters | 4 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 20 Gain of >=15 letters | 63 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 9 Gain of >=5 letters | 107 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 20 Gain of >=30 letters | 13 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 5 Gain of >=5 letters | 109 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 21 Gain of >=5 letters | 117 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 11 Gain of >=10 letters | 77 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 21 Gain of >=10 letters | 81 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 5 Gain of >=10 letters | 72 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 21 Gain of >=15 letters | 61 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 9 Gain of >=10 letters | 78 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 21 Gain of >=30 letters | 12 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 5 Gain of >=15 letters | 46 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 22 Gain of >=5 letters | 114 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 16 Gain of >=10 letters | 87 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 22 Gain of >=10 letters | 88 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 5 Gain of >=30 letters | 5 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 22 Gain of >=15 letters | 64 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 9 Gain of >=15 letters | 57 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 22 Gain of >=30 letters | 13 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 6 Gain of >=5 letters | 108 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 23 Gain of >=5 letters | 115 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 11 Gain of >=15 letters | 56 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 23 Gain of >=10 letters | 85 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 6 Gain of >=10 letters | 75 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 23 Gain of >=15 letters | 62 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 9 Gain of >=30 letters | 11 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 23 Gain of >=30 letters | 13 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 6 Gain of >=15 letters | 44 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 24 Gain of >=5 letters | 116 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 17 Gain of >=15 letters | 62 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 24 Gain of >=10 letters | 83 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 6 Gain of >=30 letters | 9 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 24 Gain of >=15 letters | 60 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 10 Gain of >=5 letters | 116 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 | Month 24 Gain of >=30 letters | 13 Patients |
Secondary
Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time
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 Month 24
Population: Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 3, Loss of < 15 letters | 160 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 14, Loss of < 15 letters | 161 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 8, Loss of < 15 letters | 162 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 15, Loss of < 15 letters | 162 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 5, Loss of < 15 letters | 160 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 16, Loss of < 15 letters | 163 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 9, Loss of < 15 letters | 163 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 17, Loss of < 15 letters | 161 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 2, Loss of < 15 letters | 163 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 18, Loss of < 15 letters | 159 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 10, Loss of < 15 letters | 162 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 19, Loss of < 15 letters | 162 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 6, Loss of < 15 letters | 162 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 20, Loss of < 15 letters | 161 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 11, Loss of < 15 letters | 162 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 21, Loss of < 15 letters | 157 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 4, Loss of < 15 letters | 161 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 22, Loss of < 15 letters | 160 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 12, Loss of < 15 letters | 162 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 23, Loss of < 15 letters | 158 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 7, Loss of < 15 letters | 162 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 24, Loss of < 15 letters | 158 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 1, Loss of < 15 letters | 164 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 13, Loss of < 15 letters | 162 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 16, Loss of < 15 letters | 159 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 2, Loss of < 15 letters | 162 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 3, Loss of < 15 letters | 162 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 4, Loss of < 15 letters | 162 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 5, Loss of < 15 letters | 160 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 6, Loss of < 15 letters | 160 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 7, Loss of < 15 letters | 158 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 8, Loss of < 15 letters | 159 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 9, Loss of < 15 letters | 159 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 10, Loss of < 15 letters | 161 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 11, Loss of < 15 letters | 161 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 12, Loss of < 15 letters | 160 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 13, Loss of < 15 letters | 157 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 14, Loss of < 15 letters | 158 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 15, Loss of < 15 letters | 159 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 1, Loss of < 15 letters | 163 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 17, Loss of < 15 letters | 157 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 18, Loss of < 15 letters | 157 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 19, Loss of < 15 letters | 155 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 20, Loss of < 15 letters | 155 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 21, Loss of < 15 letters | 155 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 22, Loss of < 15 letters | 154 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 23, Loss of < 15 letters | 153 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time | Month 24, Loss of < 15 letters | 153 Patients |
Secondary
Number of Patients With a Best Corrected Visual Acuity (BCVA) of More of 73 Letters or More
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 Month 12 and Month 24 whether a patient had a VA score of 73 or more letters
Time frame: Month 12 and 24
Population: Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab 0.5 mg Monthly | Number of Patients With a Best Corrected Visual Acuity (BCVA) of More of 73 Letters or More | Month 24>=73 letters | 63 Patients |
| Ranibizumab 0.5 mg Monthly | Number of Patients With a Best Corrected Visual Acuity (BCVA) of More of 73 Letters or More | Month 12>=73 letters | 68 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a Best Corrected Visual Acuity (BCVA) of More of 73 Letters or More | Month 12>=73 letters | 56 Patients |
| Ranibizumab 0.5 mg PRN | Number of Patients With a Best Corrected Visual Acuity (BCVA) of More of 73 Letters or More | Month 24>=73 letters | 59 Patients |