| Primary | Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye | 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. A positive change from baseline indicated improvement. | Full analysis set: The full analysis set included all randomized participants who received at least one dose of study treatment. | 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 With Ranibizumab | 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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| - OG0005.7± 0.81
- OG0012.9± 0.89
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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 | | 0.0111 | | Mean Difference (Net) | 2.78 | Standard Error of the Mean | 1.203 | 2-Sided | 95 | 0.40 | 5.16 | | | | 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. A positive change from baseline indicated improvement. | The full analysis set (FAS) was considered for the analysis. The FAS. The FAS included all randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that 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 With Ranibizumab | 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 wasassessed 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 randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point. | Posted | | Mean | Standard Deviation | micrometers (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 With Ranibizumab | 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 randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point. | Posted | | Mean | Standard Deviation | microliters (ul) | | 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 With Ranibizumab | 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 or Absence 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 | | 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 With Ranibizumab | 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 or Absence of Subretinal Fluid in Study Eye Compared to Baseline | The presence of subretinal 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 | | 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 With Ranibizumab | 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 Macular Edema (ME) Leakage | The presence of active ME leakage was assessed by fluorescein angiography (FA). | The FAS was used this analysis. The FAS included randomized participants who received at least one dose of study treatment. | Posted | | Number | | Participants | | 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 With Ranibizumab | 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 Requiring 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 FAS was used for this analysis. The FAS included all randomized participants who received at least one dose of study treatment. | 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 With Ranibizumab | 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. A positive change from baseline indicated improvement. | The FAS was used for this analysis. The FAS included randomized participants who received at least one dose of study medication. | 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 With Ranibizumab | 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 randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that 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 With Ranibizumab | 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 randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that 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 With Ranibizumab | 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 | The number of participants administered study treatments, according to treatment frequency, was assessed. | The safety set was used for this analysis. The safety set included randomized participants who received at least one dose of study treatment. Two participants from the sham group were included in the ranibizumab group 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 With Ranibizumab | 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. | The safety set was used for this analysis. The safety set included randomized participants who received at least one dose of study treatment. Two participants from the sham group were included in the ranibizumab group based on the actual treatment received. | Posted | | Number | | Participants | | 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 With Ranibizumab | 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. | The safety set was used for this analysis. The safety set included randomized participants who received at least one dose of study treatment. Two participants from the sham group were included in the ranibizumab group based on the actual treatment received. | Posted | | Number | | Number of primary reasons | | 12 months | Reasons | 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 With Ranibizumab | 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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