| Primary | Mean Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) (Letters) to Month 1 Through 12 | Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. Twelve monthly BCVA values were averaged [(Month1+Month2+...+Month12)/12], and the baseline BCVA value was subtracted from the average. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis. | Full Analysis Set (FAS). Missing values imputed by the mean value last observation carried forward (MV-LOCF). | Posted | | Mean | Standard Deviation | letters | | Baseline, Monthly from Month 1 through Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab (RFB002) | 3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser | | OG001 | Laser | Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections |
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| | | Title | Measurements |
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| - OG0006.8± 6.58
- OG0011.1± 7.73
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Cochran-Mantel-Haenszel | One-sided p-value for treatment difference is derived from the two-sided stratified Cochran-Mantel-Haenszel test using the row means score statistics. | <0.001 | | Least Squares Mean Difference | 5.8 | | | 2-Sided | 95 | 4.1 | 7.5 | | | Estimated from ANOVA (stratified) model. Stratified analysis includes DME type (focal, diffuse, honeycomb and petaloid) and Baseline BCVA(≤ 60 letters and > 60 letters) as factors. | | Superiority or Other | | |
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| Secondary | Mean Change From Baseline in BCVA (Letters) at Each Visit | Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis. | Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit. | Posted | | Mean | Standard Deviation | letters | | Baseline, Monthly from Month 1 through Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab (RFB002) | 3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser | | OG001 | Laser | Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections |
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| Secondary | Mean Change From Baseline in Central Sub-Field Thickness (CSFT) at Each Visit | CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using Optical Coherence Tomography (OCT). A negative change value indicates an improvement in macular edema, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis. | Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit. | Posted | | Mean | Standard Deviation | micrometers | | Baseline, Monthly from Month 1 through Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab (RFB002) | 3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser | | OG001 | Laser | Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections |
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| Secondary | Percentage of Patients With BCVA Gain of ≥ 10 and ≥ 15 Letters From Baseline at Month 12 | Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis. | Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF). | Posted | | Number | | percentage of participants | | Baseline, Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab (RFB002) | 3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser | | OG001 | Laser | Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections |
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| Secondary | Percentage of Patients With BCVA Loss of < 10 and < 15 Letters From Baseline to Month 12 | Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis. | Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF). | Posted | | Number | | percentage of participants | | Baseline, Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab (RFB002) | 3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser | | OG001 | Laser | Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections |
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| Secondary | Percentage of Patients With BCVA ≥ 73 Letters at Month 12 | Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. BCVA ≥ 73 letters is approximately equivalent to 20/40 on a Snellen chart. One eye (study eye) contributed to the analysis. | Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF). | Posted | | Number | | percentage of participants | | Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab (RFB002) | 3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser | | OG001 | Laser | Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections |
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| Secondary | Mean Average Change in BCVA From Month 4 to Month 12 Compared to Month 3 | Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. Nine monthly BCVA values were averaged [(Month4+Month5+...+Month12)/9],and the Month 3 BCVA value was subtracted from the average. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis. | Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF). | Posted | | Mean | Standard Deviation | letters | | Monthly from Month 3 through Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab (RFB002) | 3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser | | OG001 | Laser | Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections |
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| Secondary | Mean Change From Baseline in Patient-Reported Visual Functioning at Month 6 and Month 12, Composite Score | Visual functioning was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in visual functioning, while a negative change value indicates a worsening. | Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab (RFB002) | 3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser | | OG001 | Laser | Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections |
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| Secondary | Mean Change From Baseline in Patient-Reported General Health at Month 6 and Month 12 | General health was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in general health, while a negative change value indicates a worsening. | Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab (RFB002) | 3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser | | OG001 | Laser | Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections |
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| Secondary | Mean Change From Baseline in Patient-Reported General Vision at Month 6 and Month 12 | General vision was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in general vision, while a negative change value indicates a worsening. | Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab (RFB002) | 3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser | | OG001 | Laser | Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections |
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| Secondary | Mean Change From Baseline in Patient-Reported Color Vision at Month 6 and Month 12 | Color vision was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in color vision, while a negative change value indicates a worsening. | Full Analysis Set, observed data (no missing data imputations).The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab (RFB002) | 3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser | | OG001 | Laser | Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections |
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| Secondary | Mean Change From Baseline in Patient-Reported Peripheral Vision at Month 6 and Month 12 | Peripheral vision was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in peripheral vision, while a negative change value indicates a worsening. | Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab (RFB002) | 3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser | | OG001 | Laser | Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections |
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| Secondary | Mean Change From Baseline in Patient-Reported Ocular Pain at Month 6 and Month 12 | Ocular pain was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in ocular pain, while a negative change value indicates a worsening. | Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab (RFB002) | 3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser | | OG001 | Laser | Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections |
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| Secondary | Mean Change From Baseline in Patient-Reported Near Activities at Month 6 and Month 12 | Near activities were assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in near activities, while a negative change value indicates a worsening. | Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab (RFB002) | 3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser | | OG001 | Laser | Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections |
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| Secondary | Mean Change From Baseline in Patient-Reported Distance Activities at Month 6 and Month 12 | Distance activities were assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in distance activities, while a negative change value indicates a worsening. | Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab (RFB002) | 3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser | | OG001 | Laser | Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections |
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| Secondary | Mean Change From Baseline in Patient-Reported Social Functioning at Month 6 and Month 12 | Social functioning was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in social functioning, while a negative change value indicates a worsening. | Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab (RFB002) | 3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser | | OG001 | Laser | Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections |
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| Secondary | Mean Change From Baseline in Patient-Reported Mental Health at Month 6 and Month 12 | Mental health was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in mental health, while a negative change value indicates a worsening. | Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab (RFB002) | 3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser | | OG001 | Laser | Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections |
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| Secondary | Mean Change From Baseline in Patient-Reported Roles Difficulties at Month 6 and Month 12 | Roles difficulties were assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in roles difficulties, while a negative change value indicates a worsening. | Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab (RFB002) | 3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser | | OG001 | Laser | Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections |
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| Secondary | Mean Change From Baseline in Patient-Reported Dependency at Month 6 and Month 12 | Dependency was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in dependency, while a negative change value indicates a worsening. | Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab (RFB002) | 3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser | | OG001 | Laser | Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections |
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| Secondary | Mean Change From Baseline in Patient-Reported Driving at Month 6 and Month 12 | Driving was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in driving, while a negative change value indicates a worsening. Note: Many patients did not answer the driving related question as they did not drive at all. | Full Analysis Set, observed data (no missing data imputations).The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab (RFB002) | 3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser | | OG001 | Laser | Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections |
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| Secondary | Mean Number of Ranibizumab Re-treatments Received in the Study Eye From Month 3 Onward | A ranibizumab re-treatment was defined as an administration of ranibizumab injection at a scheduled visit following at least one non-missed visit where ranibizumab was not administered in the study eye due to visual acuity stabilization. This outcome measure was pre-specified for the Ranibizumab 0.5 mg arm only. | | Posted | | Mean | Standard Deviation | retreatments | | Monthly from Month 3 through Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab (RFB002) | 3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser |
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