| Primary | Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2 | BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. The data were analyzed using mixed model repeated measures (MMRM) which contained scheduled visit, the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate and treatment group by visit and visit by centered baseline BCVA interactions. A positive change from baseline indicated improvement. | The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and Month 2, were analyzed. | Posted | | Least Squares Mean | Standard Error | letters | | Baseline, Month 2 | | | | ID | Title | Description |
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| OG000 | Ranibizumab | A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity. | | OG001 | Sham Control | Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0009.5± 0.95
- OG001-0.4± 1.16
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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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| | Mixed Models Analysis | | <0.001 | | Mean Difference (Net) | 9.94 | Standard Error of the Mean | 1.502 | 2-Sided | 95 | 6.97 | 12.91 | | | | No | Superiority or Other | | |
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| Secondary | Change From Baseline in BCVA in Study Eye up to Month 2 | BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. The data were analyzed using analysis of covariance (ANCOVA) model which contained the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate. A positive change from baseline indicated improvement. | The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point. | Posted | | Least Squares Mean | Standard Error | letters | | Baseline, Month 1, Month 2 | | | | ID | Title | Description |
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| OG000 | Ranibizumab | A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity. | | OG001 | Sham Control | Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis. |
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| Secondary | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | CSFT was assessed by optical coherence tomography (OCT). A negative change from baseline indicates improvement. | The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point. | Posted | | Mean | Standard Deviation | micrometer (um) | | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab | A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity. | | OG001 | Sham Control | Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis. |
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| Secondary | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | CSFV was assessed OCT. A negative change from baseline indicates improvement. | The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point. | Posted | | Mean | Standard Deviation | microliter (ul) | | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab | A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity. | | OG001 | Sham Control | Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis. |
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| Secondary | Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline | The presence of intra-retinal fluid was assessed by OCT. | The FAS was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants (n), with values 'Absent' or 'Definite' for both the baseline and corresponding post-baseline time point, were included in the analysis. | Posted | | Number | | Participants | | Baseline, Month 2, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab | A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity. | | OG001 | Sham Control | Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis. |
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| Secondary | Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline | Presence of subretinal fluid in study eye compared to baseline | The FAS was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants (n), with values 'Absent' or 'Definite' for both the baseline and corresponding post-baseline time point, were included in the analysis. | Posted | | Number | | Participants | | Baseline, Month 2, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab | A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity. | | OG001 | Sham Control | Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis. |
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| Secondary | Number of Participants With Presence of Active Chorioretinal Leakage | The presence of active chorioretinal leakage was assessed by photography imaging, i.e. fluorescein angiography (FA). | The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point. | Posted | | Number | | Participants | | Baseline, Month 2, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab | A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity. | | OG001 | Sham Control | Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis. |
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| Secondary | Average Change From Baseline in BCVA | BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. BCVA was assessed at each month from Month 1 through Month 6 or at each month from Month 1 through month 12, and the data were averaged. The outcome measure is reporting the change between baseline and average BCVA from Month 1 through Month 6 or from Month 1 through Month 12 (average BCVA - baseline BCVA). A positive change from baseline indicated improvement. | The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point. | Posted | | Mean | Standard Deviation | letters | | Baseline (BL), Month 1 through Month 6, Month 1 through Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab | A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity. | | OG001 | Sham Control | Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis. |
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| Secondary | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters. | The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point. | Posted | | Number | | Participants | | Month 2, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab | A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity. | | OG001 | Sham Control | Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis. |
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| Secondary | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters. | The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point. | Posted | | Number | | Participants | | Month 2, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab | A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity. | | OG001 | Sham Control | Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis. |
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| Secondary | Number of Participants With Requirement for Rescue Treatment at Month 1 | Rescue treatment with laser photocoagulation or periocular treatment could be administered at Month 1 only if the participant had a visual acuity loss of > 5 letters due to disease activity from baseline to Month 1. | The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at Month 1, were analyzed. | Posted | | Number | | Participants | | Month 1 | | | | ID | Title | Description |
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| OG000 | Ranibizumab | A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity. | | OG001 | Sham Control | Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis. |
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| Secondary | Number of Participants With Ranibizumab Treatments in Study Eye | The number of participants administered study treatments, according to treatment frequency, was assessed. | Safety set: The safety set included randomized participants who received at least one dose of study treatment and was based on the actual treatment received. | Posted | | Number | | Participants | | Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab | A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity. | | OG001 | Sham Control | Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis. | | OG002 | Sham Without Ranibizumab | Participants did not receive ranibizumab at any time during the study. |
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| Secondary | Number of Participants With Re-treatments | The number of participants, administered re-treatments according to treatment frequency, was assessed. Re-treatment was defined as an administration of study medication following at least one non-missed visit where treatment was not administered in the study eye. Up to month 12, the maximum number of retreatments was 5. | Safety set: The safety set included randomized participants who received at least one dose of study treatment and was based on the actual treatment received. | Posted | | Number | | Paticipants | | Month 12 | | | | ID | Title | Description |
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| OG000 | Ranibizumab | A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity. | | OG001 | Sham Control | Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis. | | OG002 | Sham Without Ranibizumab | Participants did not receive ranibizumab at any time during the study. |
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| Secondary | Number of Primary Reasons for Decision to Treat by Investigator | The total number of primary reasons for decisions to treat was assessed. A single participant could have had multiple primary reasons for treatment. | Safety set: The safety set included randomized participants who received at least one dose of study treatment and was based on the actual treatment received. | Posted | | Number | | Number of primary reasons | | Month 12 | treatment decisions | Participants | | ID | Title | Description |
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| OG000 | Ranibizumab | A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity. | | OG001 | Sham Control | Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis. | | OG002 | Sham Without Ranibizumab | Participants did not receive ranibizumab at any time during the study. |
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