Age-related Macular Degeneration, Choroidal Neovascularization
Conditions
Keywords
Ranibizumab, Lucentis, choroidal neovascularization, age-related macular degeneration, treat and extend regimen
Brief summary
This study was designed to evaluate the efficacy and safety of two different regimens of 0.5 mg ranibizumab given as intravitreal injection in patients with neovascular age-related macular degeneration
Detailed description
This was a 12-month, phase IIIb, randomized, Visual Acuity assessor-masked, multi-center, interventional study assessing the efficacy and safety of the TER vs monthly regimens of 0.5 mg ranibizumab intravitreal (IVT) injections in patients with newly diagnosed nAMD. Patients will be randomized 1:1 into one of two treatment arms, Treat and Extend or monthly regimens. There will be 3 periods in this study: Screening period (up to 14days), treatment period (11 months), follow-up period (1 month). At randomization visit patients will be randomized into one of the 2 treatment groups Group I ranibizumab 0.5 mg based on monthly treatment or Group II ranibizumab 0.5 mg based on TER (randomization ratio of 1:1) and will receive the first dose of Investigational treatment. Patients in Group I the following visits will perform on monthly intervals. For patients in Group II the investigator will evaluate disease activity (i.e., signs of exudation) based on SD-OCT, and in case of absence of disease activity every next visit will be 2 weeks), with a maximum of a 12-week interval.
Interventions
0.5 mg ranibizumab (intravitreal injections) prefilled syringe)
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Male or female patients, ≥50 years of age with signed informed consent before study procedures * Visual impairment predominantly due to nAMD. * Active CNV secondary to AMD confirmed by presence of active leakage from CNV seen by fluorescein angiography (FA) and/or color fundus photography * Presence of intra- or subretinal fluid/hemorrhage seen by SD-OCT * BCVA score must be ≤ 78 and ≥ 23 letters at 4 meters starting distance using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts (approximate Snellen equivalent of 20/32 and 20/320) Key
Exclusion criteria
* Any type of advanced, severe or unstable disease, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk. * Stroke or myocardial infarction within 3 months prior to Screening. * Any active periocular or ocular infection or inflammation in both eyes. * Ocular disorders in the study eye at the time of enrollment that may confound interpretation of study results and compromise visual acuity. * Presence of amblyopia or amaurosis in the fellow eye. * History of treatment with any anti-angiogenic drugs (including any anti- vascular endothelial growth factor (anti-VEGF) agents) e.g., bevacizumab \[Avastin®\], aflibercept \[Eylea®\]) or vPDT in the study eye. * History of intravitreal treatment with corticosteroids within 6 months and history of intra-ocular surgery within 3 months in the study eye prior to the Screening. * Pregnant or nursing (lactating) women. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12 | Baseline to month 12 | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in BCVA From Baseline to Month 12 | Baseline to Month 12 | Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters |
| Average BCVA Change From Baseline to Month 12 | Baseline and every month for 12 months | 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 Baseline to Month 12 |
| Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Baseline and every month for 12 months | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like charts while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 12 and compare to Baseline |
| Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Baseline and every month for 12 months | BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters of visual acuity at Month 12 as compared with baseline |
| Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Baseline and every month for 12 months | 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.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 Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Baseline and every month for 12 months | Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 12 indicates a positive outcome |
| Number of Visits Scheduled | From Month1 to Month 11 | The number of visits scheduled according to the treat and extend regimen after treatment initiation |
| The Average Number of Days Between Injections | Month 12 | The average dosing interval was measured as the average number of days between injections |
| Percentage of Participants With Fluid Free Macula Over Time up to Month 12 | Month 12 | OCT (optical coherence tomography) was used to assess intra-retinal fluid as Measured by SD-OCT (Spectral Domain-Optical Coherence Tomography). Fluid free macula refers to absence of macular edema (as assessed by the reading center). The full analysis set was used for this evaluation but the count presented are the counts of patients in the specific treatment group who have a value for the macular edema (center involvement) at study completion. These total counts are used as the denominator for the percentages |
| Change in Central Subfield Retinal Thickness (CSFT) Over Time | 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. The Ns in the rows is the number of patients with a value for both baseline and the specific post-baseline visit |
| Percentage of Patients With Choroidal Neovascularization (CNV) Leakage Assessed by Fluorescein Angiography (FA) in the Study Eye at | Month 12 | To evaluate presence of active CNV leakage on fluorescein angiography (FA) by reading center over time up to Month 12. The full analysis set was used for this evaluation but the count presented are the counts of patients in the specific treatment group who have a value for the presence of leakage at study completion. These total counts are used as the denominator for the percentages. |
| Change From Baseline in Composite Score of the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25) | Baseline, Month 12 | The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicates the best possible response. The composite score and score of each of each construct also ranged from 0 to 100 as they are calculated as total scores divided by the number of questions. The higher the values of total scores represent better outcome |
| The Mean Number of Treatment Frequency | Month 12 | The number of injections received |
Countries
Belgium, Chile, Croatia, Denmark, Egypt, Germany, Hungary, India, Israel, Italy, Portugal, Russia, Slovakia, Slovenia, South Korea, Spain, Switzerland, Turkey (Türkiye), United Kingdom
Participant flow
Pre-assignment details
Patients were randomized 1:1 into one of two treatment arms, Treat and Extend or monthly regimens. Safety set: One patient was randomized but did not receive at least one study treatment and did not record at least one post-baseline safety assessment
Participants by arm
| Arm | Count |
|---|---|
| Group I Ranibizumab 0.5 mg TER Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen | 323 |
| Group II Ranibizumab 0.5 mg Monthly Ranibizumab 0.5 mg/0.05 mL (Monthly regimen) | 327 |
| Total | 650 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 9 | 2 |
| Overall Study | Death | 3 | 4 |
| Overall Study | Lost to Follow-up | 5 | 4 |
| Overall Study | Physician Decision | 1 | 3 |
| Overall Study | Protocol deviation | 1 | 2 |
| Overall Study | Withdrawal by Subject | 14 | 17 |
Baseline characteristics
| Characteristic | Group I Ranibizumab 0.5 mg TER | Group II Ranibizumab 0.5 mg Monthly | Total |
|---|---|---|---|
| Age, Continuous | 75.3 Years STANDARD_DEVIATION 8.61 | 75.2 Years STANDARD_DEVIATION 8.13 | 75.2 Years STANDARD_DEVIATION 8.37 |
| Sex: Female, Male Female | 179 Participants | 181 Participants | 360 Participants |
| Sex: Female, Male Male | 144 Participants | 146 Participants | 290 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 164 / 323 | 166 / 326 |
| serious Total, serious adverse events | 39 / 323 | 42 / 326 |
Outcome results
Primary
Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement
Time frame: Baseline to month 12
Population: The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and study completion after last observational carried forward (LOCF) were included in this analysis. LOCF was used as an imputation of missing data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Group I Ranibizumab 0.5 mg TER | Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12 | 6.2 Letters (EDTRS) | Standard Error 0.7 |
| Group II Ranibizumab 0.5 mg Monthly | Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12 | 8.1 Letters (EDTRS) | Standard Error 0.7 |
p-value: <0.001ANCOVA
Secondary
Average BCVA Change From 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. Mean Visual Acuity was averaged over all monthly assessments from Baseline to Month 12
Time frame: Baseline and every month for 12 months
Population: The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and average visual acuity (VA) from month 1 to study completion were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I Ranibizumab 0.5 mg TER | Average BCVA Change From Baseline to Month 12 | 6.3 Letters (EDTRS) | Standard Deviation 10.5 |
| Group II Ranibizumab 0.5 mg Monthly | Average BCVA Change From Baseline to Month 12 | 7.1 Letters (EDTRS) | Standard Deviation 9.41 |
Secondary
Change From Baseline in Composite Score of the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25)
The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicates the best possible response. The composite score and score of each of each construct also ranged from 0 to 100 as they are calculated as total scores divided by the number of questions. The higher the values of total scores represent better outcome
Time frame: Baseline, Month 12
Population: The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and post-baseline value at the specific visit were included for this analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I Ranibizumab 0.5 mg TER | Change From Baseline in Composite Score of the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25) | 2.3 Score on a scale | Standard Deviation 13.93 |
| Group II Ranibizumab 0.5 mg Monthly | Change From Baseline in Composite Score of the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25) | 4 Score on a scale | Standard Deviation 13.72 |
Secondary
Change in BCVA From Baseline to Month 12
Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters
Time frame: Baseline to Month 12
Population: The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and study completion after last observational carried forward (LOCF) were included in this analysis. LOCF was used as an imputation of missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I Ranibizumab 0.5 mg TER | Change in BCVA From Baseline to Month 12 | 6.4 Letters (EDTRS) | Standard Deviation 14.11 |
| Group II Ranibizumab 0.5 mg Monthly | Change in BCVA From Baseline to Month 12 | 8.0 Letters (EDTRS) | Standard Deviation 11.61 |
Secondary
Change in Central Subfield Retinal 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. The Ns in the rows is the number of patients with a value for both baseline and the specific post-baseline visit
Time frame: Month 12
Population: The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Ranibizumab 0.5 mg TER | Change in Central Subfield Retinal Thickness (CSFT) Over Time | Month 1 (n=311, 316) | -137.6 microns | Standard Deviation 132.33 |
| Group I Ranibizumab 0.5 mg TER | Change in Central Subfield Retinal Thickness (CSFT) Over Time | Month 2 (n=220, 311) | -151.6 microns | Standard Deviation 151.15 |
| Group I Ranibizumab 0.5 mg TER | Change in Central Subfield Retinal Thickness (CSFT) Over Time | Month 3 (n=157, 304) | -149.8 microns | Standard Deviation 167.26 |
| Group I Ranibizumab 0.5 mg TER | Change in Central Subfield Retinal Thickness (CSFT) Over Time | Month 4 (n=125, 307) | -141.8 microns | Standard Deviation 183.71 |
| Group I Ranibizumab 0.5 mg TER | Change in Central Subfield Retinal Thickness (CSFT) Over Time | Month 5 (n=110, 295) | -138.6 microns | Standard Deviation 160.04 |
| Group I Ranibizumab 0.5 mg TER | Change in Central Subfield Retinal Thickness (CSFT) Over Time | Month 6 (n=113, 298) | -140.1 microns | Standard Deviation 156.25 |
| Group I Ranibizumab 0.5 mg TER | Change in Central Subfield Retinal Thickness (CSFT) Over Time | Month 7 (n=173, 296) | -146.6 microns | Standard Deviation 160.72 |
| Group I Ranibizumab 0.5 mg TER | Change in Central Subfield Retinal Thickness (CSFT) Over Time | Month 8 (n=159, 290) | -153.4 microns | Standard Deviation 151.93 |
| Group I Ranibizumab 0.5 mg TER | Change in Central Subfield Retinal Thickness (CSFT) Over Time | Month 9 (n=126, 286) | -150.2 microns | Standard Deviation 153.82 |
| Group I Ranibizumab 0.5 mg TER | Change in Central Subfield Retinal Thickness (CSFT) Over Time | Month 10 (n=156, 291) | -154.6 microns | Standard Deviation 162.77 |
| Group I Ranibizumab 0.5 mg TER | Change in Central Subfield Retinal Thickness (CSFT) Over Time | Month 11 (n=127, 285) | -133.1 microns | Standard Deviation 170.47 |
| Group I Ranibizumab 0.5 mg TER | Change in Central Subfield Retinal Thickness (CSFT) Over Time | Month 12 (n=289, 287) | -172.1 microns | Standard Deviation 162.81 |
| Group II Ranibizumab 0.5 mg Monthly | Change in Central Subfield Retinal Thickness (CSFT) Over Time | Month 11 (n=127, 285) | -174.8 microns | Standard Deviation 163.16 |
| Group II Ranibizumab 0.5 mg Monthly | Change in Central Subfield Retinal Thickness (CSFT) Over Time | Month 1 (n=311, 316) | -126.8 microns | Standard Deviation 119.47 |
| Group II Ranibizumab 0.5 mg Monthly | Change in Central Subfield Retinal Thickness (CSFT) Over Time | Month 7 (n=173, 296) | -166.9 microns | Standard Deviation 161.49 |
| Group II Ranibizumab 0.5 mg Monthly | Change in Central Subfield Retinal Thickness (CSFT) Over Time | Month 2 (n=220, 311) | -149.2 microns | Standard Deviation 137.6 |
| Group II Ranibizumab 0.5 mg Monthly | Change in Central Subfield Retinal Thickness (CSFT) Over Time | Month 10 (n=156, 291) | -170.9 microns | Standard Deviation 153.9 |
| Group II Ranibizumab 0.5 mg Monthly | Change in Central Subfield Retinal Thickness (CSFT) Over Time | Month 3 (n=157, 304) | -151.8 microns | Standard Deviation 149.51 |
| Group II Ranibizumab 0.5 mg Monthly | Change in Central Subfield Retinal Thickness (CSFT) Over Time | Month 8 (n=159, 290) | -170.4 microns | Standard Deviation 156.68 |
| Group II Ranibizumab 0.5 mg Monthly | Change in Central Subfield Retinal Thickness (CSFT) Over Time | Month 4 (n=125, 307) | -161.3 microns | Standard Deviation 149.36 |
| Group II Ranibizumab 0.5 mg Monthly | Change in Central Subfield Retinal Thickness (CSFT) Over Time | Month 12 (n=289, 287) | -173.3 microns | Standard Deviation 154.13 |
| Group II Ranibizumab 0.5 mg Monthly | Change in Central Subfield Retinal Thickness (CSFT) Over Time | Month 5 (n=110, 295) | -160.9 microns | Standard Deviation 148.23 |
| Group II Ranibizumab 0.5 mg Monthly | Change in Central Subfield Retinal Thickness (CSFT) Over Time | Month 9 (n=126, 286) | -169.3 microns | Standard Deviation 156.5 |
| Group II Ranibizumab 0.5 mg Monthly | Change in Central Subfield Retinal Thickness (CSFT) Over Time | Month 6 (n=113, 298) | -163.4 microns | Standard Deviation 157.18 |
Secondary
Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like charts while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 12 and compare to Baseline
Time frame: Baseline and every month for 12 months
Population: The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I Ranibizumab 0.5 mg TER | Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Month 1 (n=320, 322) | 4.6 Letters (EDTRS) | Standard Deviation 7.56 |
| Group I Ranibizumab 0.5 mg TER | Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Month 2 (n=240, 316) | 5.5 Letters (EDTRS) | Standard Deviation 8.64 |
| Group I Ranibizumab 0.5 mg TER | Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Month 3 (n=247, 311) | 6.7 Letters (EDTRS) | Standard Deviation 9.09 |
| Group I Ranibizumab 0.5 mg TER | Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Month 4 (n=213, 314) | 7.0 Letters (EDTRS) | Standard Deviation 10.9 |
| Group I Ranibizumab 0.5 mg TER | Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Month 5 (n=231, 302) | 6.0 Letters (EDTRS) | Standard Deviation 11.34 |
| Group I Ranibizumab 0.5 mg TER | Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | month 6 (n=205, 302) | 6.9 Letters (EDTRS) | Standard Deviation 13.34 |
| Group I Ranibizumab 0.5 mg TER | Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Month 7 (n=230, 298) | 5.9 Letters (EDTRS) | Standard Deviation 14.25 |
| Group I Ranibizumab 0.5 mg TER | Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Month 8 (n=210, 295) | 7.5 Letters (EDTRS) | Standard Deviation 12.87 |
| Group I Ranibizumab 0.5 mg TER | Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Month 9 (n=179, 295) | 6.6 Letters (EDTRS) | Standard Deviation 13.63 |
| Group I Ranibizumab 0.5 mg TER | Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Month 10 (n=202, 296) | 6.3 Letters (EDTRS) | Standard Deviation 13.44 |
| Group I Ranibizumab 0.5 mg TER | Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Month 11 (n=180, 290) | 5.9 Letters (EDTRS) | Standard Deviation 14.12 |
| Group I Ranibizumab 0.5 mg TER | Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Month 12 (n=294, 295) | 6.6 Letters (EDTRS) | Standard Deviation 13.41 |
| Group II Ranibizumab 0.5 mg Monthly | Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Month 11 (n=180, 290) | 7.5 Letters (EDTRS) | Standard Deviation 12.48 |
| Group II Ranibizumab 0.5 mg Monthly | Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Month 1 (n=320, 322) | 4.2 Letters (EDTRS) | Standard Deviation 6.98 |
| Group II Ranibizumab 0.5 mg Monthly | Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Month 7 (n=230, 298) | 7.9 Letters (EDTRS) | Standard Deviation 11.36 |
| Group II Ranibizumab 0.5 mg Monthly | Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Month 2 (n=240, 316) | 5.8 Letters (EDTRS) | Standard Deviation 8.58 |
| Group II Ranibizumab 0.5 mg Monthly | Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Month 10 (n=202, 296) | 7.6 Letters (EDTRS) | Standard Deviation 12.06 |
| Group II Ranibizumab 0.5 mg Monthly | Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Month 3 (n=247, 311) | 6.7 Letters (EDTRS) | Standard Deviation 9.19 |
| Group II Ranibizumab 0.5 mg Monthly | Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Month 8 (n=210, 295) | 7.9 Letters (EDTRS) | Standard Deviation 11.34 |
| Group II Ranibizumab 0.5 mg Monthly | Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Month 4 (n=213, 314) | 7.3 Letters (EDTRS) | Standard Deviation 9.95 |
| Group II Ranibizumab 0.5 mg Monthly | Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Month 12 (n=294, 295) | 7.9 Letters (EDTRS) | Standard Deviation 11.96 |
| Group II Ranibizumab 0.5 mg Monthly | Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Month 5 (n=231, 302) | 7.7 Letters (EDTRS) | Standard Deviation 10.61 |
| Group II Ranibizumab 0.5 mg Monthly | Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Month 9 (n=179, 295) | 7.6 Letters (EDTRS) | Standard Deviation 12.56 |
| Group II Ranibizumab 0.5 mg Monthly | Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | month 6 (n=205, 302) | 7.9 Letters (EDTRS) | Standard Deviation 10.83 |
Secondary
Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12
BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters of visual acuity at Month 12 as compared with baseline
Time frame: Baseline and every month for 12 months
Population: The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 7, Gain of >= 1 letter (n=176, 298) | 126 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 2, Gain of >= 15 letters | 30 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 7, Gain of >= 5 letters | 94 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 4, Gain of >= 5 letters | 67 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 7, Gain of >= 10 letters | 57 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 1, Gain of ≥ 5 letters | 145 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 7, Gain of >= 15 letters | 33 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 4, Gain of >=10 letters | 48 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 7, Gain of >= 30 letters | 7 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 2, Gain of >= 30 letters | 4 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 8, Gain of >= 1 letter (n=163, 295) | 124 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 4, Gain of >= 15 letters | 25 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 8, Gain of >= 5 letters | 108 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 2, Gain of >= 1 letter (n=226, 316) | 168 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 8, Gain of >= 10 letters | 69 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 4, Gain of >= 30 letters | 4 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 8, Gain of >= 15 letters | 40 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 3, Gain of >= 1 letter (n=161,311) | 120 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 8, Gain of >= 30 letters | 4 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 5, Gain of >= 1 letter (n=114, 302) | 84 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 9, Gain of >= 1 letter (n=129, 295) | 93 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 1, Gain of ≥ 15 letters | 24 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 9, Gain of >= 5 letters | 78 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 5, Gain of >= 5 letters | 64 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 9, Gain of >= 10 letters | 52 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 3, Gain of >= 5 letters | 98 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 9, Gain of >= 15 letters | 28 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 5, Gain of >= 10 letters | 42 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 9, Gain of >= 30 letters | 5 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 2, Gain of >= 5 letters | 123 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 10, Gain of >= 1 letter (n=159, 296) | 113 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 5, Gain of >= 15 letters | 19 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 10, Gain of >= 5 letters | 98 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 3, Gain of >= 10 letters | 57 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 10, Gain of >= 10 letters | 60 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 5, Gain of >= 30 letters | 3 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 10, Gain of >= 15 letters | 32 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 1, Gain of ≥ 10 letters | 65 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 10, Gain of >= 30 letters | 4 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 6, Gain of >= 1 letter (n=117, 302) | 85 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 11, Gain of >= 1 letter (131, 290) | 94 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 3, Gain of >= 15 letters | 28 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 11, Gain of >= 5 letters | 79 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 6, Gain of >= 5 letters | 68 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 11, Gain of >= 10 letters | 51 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 2, Gain of >= 10 letters | 60 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 11, Gain of >= 15 letters | 32 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 6, Gain of >= 10 letters | 42 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 11, Gain of >= 30 letters | 5 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 3, Gain of >= 30 letters | 2 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 12, Gain of >= 1 letter (n=291, 295) | 217 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 6, Gain of >= 15 letters | 19 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 12, Gain of >= 5 letters | 178 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 1, Gain of ≥ 30 letters | 4 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 12, Gain of >= 10 letters | 123 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 6, Gain of >= 30 letters | 2 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 12, Gain of >= 15 letters | 75 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 4, Gain of >= 1 letter (n=128, 314) | 96 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 12, Gain of >= 30 letters | 12 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 1,Gain of ≥ 1 letter (n=320,322) | 235 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 12, Gain of >= 30 letters | 8 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 1,Gain of ≥ 1 letter (n=320,322) | 233 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 1, Gain of ≥ 5 letters | 145 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 1, Gain of ≥ 10 letters | 58 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 1, Gain of ≥ 15 letters | 23 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 1, Gain of ≥ 30 letters | 2 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 2, Gain of >= 1 letter (n=226, 316) | 244 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 2, Gain of >= 5 letters | 184 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 2, Gain of >= 10 letters | 88 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 2, Gain of >= 15 letters | 39 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 2, Gain of >= 30 letters | 3 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 3, Gain of >= 1 letter (n=161,311) | 244 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 3, Gain of >= 5 letters | 187 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 3, Gain of >= 10 letters | 110 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 3, Gain of >= 15 letters | 46 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 3, Gain of >= 30 letters | 3 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 4, Gain of >= 1 letter (n=128, 314) | 249 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 4, Gain of >= 5 letters | 198 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 4, Gain of >=10 letters | 118 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 4, Gain of >= 15 letters | 60 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 4, Gain of >= 30 letters | 8 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 5, Gain of >= 1 letter (n=114, 302) | 243 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 5, Gain of >= 5 letters | 197 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 5, Gain of >= 10 letters | 116 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 5, Gain of >= 15 letters | 59 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 5, Gain of >= 30 letters | 10 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 6, Gain of >= 1 letter (n=117, 302) | 238 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 6, Gain of >= 5 letters | 197 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 6, Gain of >= 10 letters | 125 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 6, Gain of >= 15 letters | 61 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 6, Gain of >= 30 letters | 11 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 7, Gain of >= 1 letter (n=176, 298) | 235 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 7, Gain of >= 5 letters | 196 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 7, Gain of >= 10 letters | 123 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 7, Gain of >= 15 letters | 69 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 7, Gain of >= 30 letters | 9 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 8, Gain of >= 1 letter (n=163, 295) | 228 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 8, Gain of >= 5 letters | 198 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 8, Gain of >= 10 letters | 130 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 8, Gain of >= 15 letters | 72 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 8, Gain of >= 30 letters | 9 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 9, Gain of >= 1 letter (n=129, 295) | 229 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 9, Gain of >= 5 letters | 186 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 9, Gain of >= 10 letters | 128 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 9, Gain of >= 15 letters | 70 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 9, Gain of >= 30 letters | 8 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 10, Gain of >= 1 letter (n=159, 296) | 230 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 10, Gain of >= 5 letters | 190 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 10, Gain of >= 10 letters | 126 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 10, Gain of >= 15 letters | 74 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 10, Gain of >= 30 letters | 10 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 11, Gain of >= 1 letter (131, 290) | 222 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 11, Gain of >= 5 letters | 187 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 11, Gain of >= 10 letters | 130 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 11, Gain of >= 15 letters | 74 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 11, Gain of >= 30 letters | 9 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 12, Gain of >= 1 letter (n=291, 295) | 226 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 12, Gain of >= 5 letters | 199 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 12, Gain of >= 10 letters | 135 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Month 12, Gain of >= 15 letters | 77 Number of participants |
Secondary
Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12
Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 12 indicates a positive outcome
Time frame: Baseline and every month for 12 months
Population: The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Month 1 (n=320, 322) | 106 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Month 2 (n=226, 316) | 74 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Month 3 (n=161, 311) | 67 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Month 4 (n=128, 314) | 60 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Month 5 (n=114, 302) | 51 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Month 6 (n=117, 302) | 58 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Month 7 (n=176, 298) | 78 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Month 8 (n=163, 295) | 84 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Month 9 (n=129, 295) | 68 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Month 10 (n=159, 296) | 74 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Month 11 (n=131, 290 | 63 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Month 12 (n=291, 295) | 131 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Month 11 (n=131, 290 | 143 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Month 1 (n=320, 322) | 106 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Month 7 (n=176, 298) | 150 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Month 2 (n=226, 316) | 136 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Month 10 (n=159, 296) | 149 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Month 3 (n=161, 311) | 148 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Month 8 (n=163, 295) | 155 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Month 4 (n=128, 314) | 147 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Month 12 (n=291, 295) | 149 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Month 5 (n=114, 302) | 156 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Month 9 (n=129, 295) | 156 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Month 6 (n=117, 302) | 155 Number of participants |
Secondary
Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit
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.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 and every month for 12 months
Population: The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 7, Loss of < 5 letters (n=176, 298) | 148 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 2, Loss of < 15 letters | 223 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 7, Loss of < 10 letters | 162 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 4, Loss of < 10 letters | 128 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 7, Loss of < 15 letters | 166 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 2, Loss of < 5 letters (n=226, 316) | 205 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 8, Loss of < 5 letters (n=163, 295) | 145 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 4, Loss of < 15 letters | 124 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 8, Loss of < 10 letters | 155 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 3, Loss of < 5 letters (n=161, 311) | 146 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 8, Loss of < 15 letters | 155 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 5, Loss of < 5 letters (n=114, 302) | 97 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 9, Loss of < 5 letters (n=129, 295) | 110 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 1, Loss of < 15 letters | 319 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 9, Loss of < 10 letters | 120 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 5, Loss of < 10 letters | 105 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 9, Loss of < 15 letters | 122 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 3, Loss of < 10 letters | 158 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 10, Loss of < 5 letters(n=159, 296) | 133 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 5, Loss of < 15 letters | 108 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 10, Loss of < 10 letters | 147 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 2, Loss of < 10 letters | 220 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 10, Loss of < 15 letters | 150 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 6, Loss of < 5 letters (n=117, 302) | 104 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 11, Loss of < 5 letters (n=131, 290) | 105 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 3, Loss of < 15 letters | 160 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 11, Loss of < 10 letters | 118 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 6, Loss of < 10 letters | 110 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 11, Loss of < 15 letters | 121 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 1, Loss of < 10 letters | 313 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 12, Loss of < 5 letters (291, 295) | 247 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 6, Loss of < 15 letters | 111 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 12, Loss of < 10 letters | 267 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 4, Loss of < 5 letters (n=128, 314) | 114 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 12, Loss of < 15 letters | 273 Number of participants |
| Group I Ranibizumab 0.5 mg TER | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 1, Loss of < 5 letters (n=320, 322) | 296 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 12, Loss of < 15 letters | 284 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 1, Loss of < 5 letters (n=320, 322) | 295 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 1, Loss of < 10 letters | 314 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 1, Loss of < 15 letters | 320 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 2, Loss of < 5 letters (n=226, 316) | 288 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 2, Loss of < 10 letters | 306 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 2, Loss of < 15 letters | 309 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 3, Loss of < 5 letters (n=161, 311) | 289 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 3, Loss of < 10 letters | 299 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 3, Loss of < 15 letters | 304 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 4, Loss of < 5 letters (n=128, 314) | 286 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 4, Loss of < 10 letters | 301 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 4, Loss of < 15 letters | 307 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 5, Loss of < 5 letters (n=114, 302) | 276 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 5, Loss of < 10 letters | 287 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 5, Loss of < 15 letters | 295 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 6, Loss of < 5 letters (n=117, 302) | 271 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 6, Loss of < 10 letters | 286 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 6, Loss of < 15 letters | 298 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 7, Loss of < 5 letters (n=176, 298) | 268 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 7, Loss of < 10 letters | 279 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 7, Loss of < 15 letters | 289 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 8, Loss of < 5 letters (n=163, 295) | 262 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 8, Loss of < 10 letters | 276 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 8, Loss of < 15 letters | 286 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 9, Loss of < 5 letters (n=129, 295) | 258 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 9, Loss of < 10 letters | 270 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 9, Loss of < 15 letters | 281 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 10, Loss of < 5 letters(n=159, 296) | 253 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 10, Loss of < 10 letters | 276 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 10, Loss of < 15 letters | 285 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 11, Loss of < 5 letters (n=131, 290) | 251 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 11, Loss of < 10 letters | 263 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 11, Loss of < 15 letters | 275 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 12, Loss of < 5 letters (291, 295) | 256 Number of participants |
| Group II Ranibizumab 0.5 mg Monthly | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Month 12, Loss of < 10 letters | 272 Number of participants |
Secondary
Number of Visits Scheduled
The number of visits scheduled according to the treat and extend regimen after treatment initiation
Time frame: From Month1 to Month 11
Population: The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I Ranibizumab 0.5 mg TER | Number of Visits Scheduled | 8.9 Number of visits | Standard Deviation 2.56 |
| Group II Ranibizumab 0.5 mg Monthly | Number of Visits Scheduled | 11.2 Number of visits | Standard Deviation 2.37 |
Secondary
Percentage of Participants With Fluid Free Macula Over Time up to Month 12
OCT (optical coherence tomography) was used to assess intra-retinal fluid as Measured by SD-OCT (Spectral Domain-Optical Coherence Tomography). Fluid free macula refers to absence of macular edema (as assessed by the reading center). The full analysis set was used for this evaluation but the count presented are the counts of patients in the specific treatment group who have a value for the macular edema (center involvement) at study completion. These total counts are used as the denominator for the percentages
Time frame: Month 12
Population: Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group I Ranibizumab 0.5 mg TER | Percentage of Participants With Fluid Free Macula Over Time up to Month 12 | Absent | 60.5 Percentage of participants |
| Group I Ranibizumab 0.5 mg TER | Percentage of Participants With Fluid Free Macula Over Time up to Month 12 | Definite | 39.5 Percentage of participants |
| Group I Ranibizumab 0.5 mg TER | Percentage of Participants With Fluid Free Macula Over Time up to Month 12 | Can't grade | 0.0 Percentage of participants |
| Group II Ranibizumab 0.5 mg Monthly | Percentage of Participants With Fluid Free Macula Over Time up to Month 12 | Absent | 60.7 Percentage of participants |
| Group II Ranibizumab 0.5 mg Monthly | Percentage of Participants With Fluid Free Macula Over Time up to Month 12 | Definite | 39 Percentage of participants |
| Group II Ranibizumab 0.5 mg Monthly | Percentage of Participants With Fluid Free Macula Over Time up to Month 12 | Can't grade | 0.3 Percentage of participants |
Secondary
Percentage of Patients With Choroidal Neovascularization (CNV) Leakage Assessed by Fluorescein Angiography (FA) in the Study Eye at
To evaluate presence of active CNV leakage on fluorescein angiography (FA) by reading center over time up to Month 12. The full analysis set was used for this evaluation but the count presented are the counts of patients in the specific treatment group who have a value for the presence of leakage at study completion. These total counts are used as the denominator for the percentages.
Time frame: Month 12
Population: Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group I Ranibizumab 0.5 mg TER | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage Assessed by Fluorescein Angiography (FA) in the Study Eye at | Yes | 18.7 Percentage of participants |
| Group I Ranibizumab 0.5 mg TER | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage Assessed by Fluorescein Angiography (FA) in the Study Eye at | No | 74.1 Percentage of participants |
| Group I Ranibizumab 0.5 mg TER | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage Assessed by Fluorescein Angiography (FA) in the Study Eye at | Can't grade | 0.0 Percentage of participants |
| Group I Ranibizumab 0.5 mg TER | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage Assessed by Fluorescein Angiography (FA) in the Study Eye at | Not applicable | 7.2 Percentage of participants |
| Group II Ranibizumab 0.5 mg Monthly | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage Assessed by Fluorescein Angiography (FA) in the Study Eye at | Not applicable | 3.5 Percentage of participants |
| Group II Ranibizumab 0.5 mg Monthly | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage Assessed by Fluorescein Angiography (FA) in the Study Eye at | Yes | 17.1 Percentage of participants |
| Group II Ranibizumab 0.5 mg Monthly | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage Assessed by Fluorescein Angiography (FA) in the Study Eye at | Can't grade | 2.4 Percentage of participants |
| Group II Ranibizumab 0.5 mg Monthly | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage Assessed by Fluorescein Angiography (FA) in the Study Eye at | No | 76.9 Percentage of participants |
Secondary
The Average Number of Days Between Injections
The average dosing interval was measured as the average number of days between injections
Time frame: Month 12
Population: Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I Ranibizumab 0.5 mg TER | The Average Number of Days Between Injections | 40.3 days | Standard Deviation 11.28 |
| Group II Ranibizumab 0.5 mg Monthly | The Average Number of Days Between Injections | 29.4 days | Standard Deviation 3.27 |
Secondary
The Mean Number of Treatment Frequency
The number of injections received
Time frame: Month 12
Population: Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I Ranibizumab 0.5 mg TER | The Mean Number of Treatment Frequency | 8.7 Number of injections | Standard Deviation 2.68 |
| Group II Ranibizumab 0.5 mg Monthly | The Mean Number of Treatment Frequency | 11.0 Number of injections | Standard Deviation 2.5 |