Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT00275821 EXCITE | Macular Degeneration | Mean Change From Baseline in Best-corrected Visual Acuity of the Study Eye at Month 12 Baseline to Month 12 | Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly | 4.9 letters (±13.13 Standard Deviation) |
| Ranibizumab 0.3 mg Monthly | 8.3 letters (±11.31 Standard Deviation) | |||
| Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly | 3.8 letters (±13.33 Standard Deviation) | |||
| NCT00331864 | Macular Degeneration | Percentage of Patients With Ocular Adverse Events (AEs) in the Study Eye Baseline through end of study (12 month treatment period) | Ranibizumab ANCHOR | 38.9 Percentage of Participants |
| Ranibizumab Non-ANCHOR | 48.5 Percentage of Participants | |||
| NCT00331864 | Macular Degeneration | Percentage of Patients With Targeted Grade 3 Adverse Events (AEs) in the Study Eye Baseline through end of study (12 month treatment period) | Ranibizumab ANCHOR | 0.0 Percentage of Participants |
| Ranibizumab Non-ANCHOR | 2.9 Percentage of Participants | |||
| NCT00384449 | Eales disease | Change in OCT Thickness. Baseline and 6 months | Lucentis (Ranibizumab) | 262 um |
| Lucentis (Ranibizumab) | 269 um | |||
| NCT00384449 | Eales disease | Incidence and Severity of Ocular Adverse Events, as Identified by Eye Examination (Including Visual Acuity Testing) Monthly through Month 6 | Lucentis (Ranibizumab) | 0 adverse events |
| NCT00384449 | Eales disease | Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs Monthly through Month 6 | Lucentis (Ranibizumab) | 0 adverse events |
| NCT00433017 | Macular Degeneration | Change From Baseline in Best-corrected Visual Acuity (BCVA) at Month 12. Baseline and Month 12 | Ranibizumab | 59.4 Letters (±18.8 Standard Deviation) |
| Ranibizumab | 55.1 Letters (±12.3 Standard Deviation) | |||
| Ranibizumab | 4.4 Letters (±15.92 Standard Deviation) | |||
| Verteporfin + Ranibizumab | 54.6 Letters (±13.5 Standard Deviation) | |||
| Verteporfin + Ranibizumab | 2.5 Letters (±14.82 Standard Deviation) | |||
| Verteporfin + Ranibizumab | 57.1 Letters (±18.3 Standard Deviation) | |||
| NCT00433017 | Macular Degeneration | Percent of Participants With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit Month 2 to Month 11 | Ranibizumab | 92.2 Percentage of Participants |
| Verteporfin + Ranibizumab | 95.8 Percentage of Participants | |||
| NCT00436553 | Macular Degeneration | Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12 Baseline and Month 12 | Ranibizumab Monotherapy | 8.1 Letters (±15.09 Standard Deviation) |
| Ranibizumab Monotherapy | 54.8 Letters (±13.55 Standard Deviation) | |||
| Ranibizumab Monotherapy | 63.0 Letters (±18.88 Standard Deviation) | |||
| Verteporfin RF + Ranibizumab | 4.4 Letters (±15.47 Standard Deviation) | |||
| Verteporfin RF + Ranibizumab | 54.6 Letters (±12.78 Standard Deviation) | |||
| Verteporfin RF + Ranibizumab | 59.0 Letters (±18.03 Standard Deviation) | |||
| Verteporfin SF + Ranibizumab | 53.7 Letters (±13.52 Standard Deviation) | |||
| Verteporfin SF + Ranibizumab | 5.3 Letters (±15.66 Standard Deviation) | |||
| Verteporfin SF + Ranibizumab | 59.0 Letters (±17.47 Standard Deviation) | |||
| NCT00436553 | Macular Degeneration | Percent of Patients With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit Month 2 up to Month 11 | Verteporfin RF + Ranibizumab | 83.5 Percent of participants |
| Verteporfin SF + Ranibizumab | 92.6 Percent of participants | |||
| NCT00444600 LRT for DME | Diabetic Retinopathy | Change in Visual Acuity From Baseline to 1 Year Among Eyes That Had Prior Treatment for Diabetic Macular Edema from baseline to 1 Year | 0.5 mg Ranibizumab+Deferred Laser | 8 Letters (±12 Standard Deviation) |
| 0.5 mg Ranibizumab+Deferred Laser | 11 Letters (±13 Standard Deviation) | |||
| 0.5 mg Ranibizumab+Prompt Laser | 9 Letters (±10 Standard Deviation) | |||
| 0.5 mg Ranibizumab+Prompt Laser | 9 Letters (±12 Standard Deviation) | |||
| 4 mg Triamcinolone+Prompt Laser | 3 Letters (±13 Standard Deviation) | |||
| 4 mg Triamcinolone+Prompt Laser | 5 Letters (±13 Standard Deviation) | |||
| Sham+Prompt Laser | 3 Letters (±13 Standard Deviation) | |||
| Sham+Prompt Laser | 2 Letters (±14 Standard Deviation) | |||
| NCT00444600 LRT for DME | Diabetic Retinopathy | Change in Visual Acuity From Baseline to 1 Year Among Eyes That Were Pseudophakic at Baseline from baseline to 1 Year | 0.5 mg Ranibizumab+Deferred Laser | 7 Letters (±9 Standard Deviation) |
| 0.5 mg Ranibizumab+Deferred Laser | 10 Letters (±14 Standard Deviation) | |||
| 0.5 mg Ranibizumab+Prompt Laser | 8 Letters (±12 Standard Deviation) | |||
| 0.5 mg Ranibizumab+Prompt Laser | 9 Letters (±10 Standard Deviation) | |||
| 4 mg Triamcinolone+Prompt Laser | 8 Letters (±9 Standard Deviation) | |||
| 4 mg Triamcinolone+Prompt Laser | 2 Letters (±14 Standard Deviation) | |||
| Sham+Prompt Laser | 4 Letters (±14 Standard Deviation) | |||
| Sham+Prompt Laser | 2 Letters (±13 Standard Deviation) | |||
| NCT00444600 LRT for DME | Diabetic Retinopathy | Change in Visual Acuity From Baseline to 1 Year Grouped by Baseline Visual Acuity Letter Score from baseline to 1 Year | 0.5 mg Ranibizumab+Deferred Laser | 13 Letters (±10 Standard Deviation) |
| 0.5 mg Ranibizumab+Deferred Laser | 5 Letters (±13 Standard Deviation) | |||
| 0.5 mg Ranibizumab+Prompt Laser | 12 Letters (±11 Standard Deviation) | |||
| 0.5 mg Ranibizumab+Prompt Laser | 6 Letters (±10 Standard Deviation) | |||
| 4 mg Triamcinolone+Prompt Laser | 1 Letters (±11 Standard Deviation) | |||
| 4 mg Triamcinolone+Prompt Laser | 7 Letters (±14 Standard Deviation) | |||
| Sham+Prompt Laser | 1 Letters (±12 Standard Deviation) | |||
| Sham+Prompt Laser | 5 Letters (±14 Standard Deviation) | |||
| NCT00444600 LRT for DME | Diabetic Retinopathy | Change in Visual Acuity From Baseline to 1 Year Grouped by Diabetic Retinopathy Severity from baseline to 1 Year | 0.5 mg Ranibizumab+Deferred Laser | 9 Letters (±13 Standard Deviation) |
| 0.5 mg Ranibizumab+Deferred Laser | 9 Letters (±12 Standard Deviation) | |||
| 0.5 mg Ranibizumab+Prompt Laser | 10 Letters (±11 Standard Deviation) | |||
| 0.5 mg Ranibizumab+Prompt Laser | 8 Letters (±10 Standard Deviation) | |||
| 4 mg Triamcinolone+Prompt Laser | 5 Letters (±12 Standard Deviation) | |||
| 4 mg Triamcinolone+Prompt Laser | 3 Letters (±14 Standard Deviation) | |||
| Sham+Prompt Laser | 3 Letters (±13 Standard Deviation) | |||
| Sham+Prompt Laser | 2 Letters (±15 Standard Deviation) | |||
| NCT00444600 LRT for DME | Diabetic Retinopathy | Change in Visual Acuity From Baseline to 1 Year Grouped by Diffuse vs. Focal Edema as Characterized by the Investigator from baseline to 1 Year | 0.5 mg Ranibizumab+Deferred Laser | 8 Letters (±13 Standard Deviation) |
| 0.5 mg Ranibizumab+Deferred Laser | 8 Letters (±15 Standard Deviation) | |||
| 0.5 mg Ranibizumab+Deferred Laser | 10 Letters (±10 Standard Deviation) | |||
| 0.5 mg Ranibizumab+Prompt Laser | 9 Letters (±12 Standard Deviation) | |||
| 0.5 mg Ranibizumab+Prompt Laser | 10 Letters (±9 Standard Deviation) | |||
| 0.5 mg Ranibizumab+Prompt Laser | 8 Letters (±11 Standard Deviation) | |||
| 4 mg Triamcinolone+Prompt Laser | 3 Letters (±13 Standard Deviation) | |||
| 4 mg Triamcinolone+Prompt Laser | 3 Letters (±11 Standard Deviation) | |||
| 4 mg Triamcinolone+Prompt Laser | 5 Letters (±14 Standard Deviation) | |||
| Sham+Prompt Laser | 3 Letters (±13 Standard Deviation) | |||
| Sham+Prompt Laser | 3 Letters (±13 Standard Deviation) | |||
| Sham+Prompt Laser | 2 Letters (±14 Standard Deviation) | |||
| NCT00444600 LRT for DME | Diabetic Retinopathy | Change in Visual Acuity From Baseline to 1 Year Grouped by Optical Coherence Tomography Central Subfield Thickness from baseline to 1 Year | 0.5 mg Ranibizumab+Deferred Laser | 11 Letters (±13 Standard Deviation) |
| 0.5 mg Ranibizumab+Deferred Laser | 7 Letters (±12 Standard Deviation) | |||
| 0.5 mg Ranibizumab+Prompt Laser | 7 Letters (±11 Standard Deviation) | |||
| 0.5 mg Ranibizumab+Prompt Laser | 11 Letters (±10 Standard Deviation) | |||
| 4 mg Triamcinolone+Prompt Laser | 3 Letters (±12 Standard Deviation) | |||
| 4 mg Triamcinolone+Prompt Laser | 6 Letters (±14 Standard Deviation) | |||
| Sham+Prompt Laser | 3 Letters (±15 Standard Deviation) | |||
| Sham+Prompt Laser | 3 Letters (±11 Standard Deviation) | |||
| NCT00444600 LRT for DME | Diabetic Retinopathy | Distribution of Change in Visual Acuity (Letters) From Baseline to 1 Year from baseline to 1 Year | 0.5 mg Ranibizumab+Deferred Laser | 36 Eyes |
| 0.5 mg Ranibizumab+Deferred Laser | 4 Eyes | |||
| 0.5 mg Ranibizumab+Deferred Laser | 2 Eyes | |||
| 0.5 mg Ranibizumab+Deferred Laser | 5 Eyes | |||
| 0.5 mg Ranibizumab+Deferred Laser | 35 Eyes | |||
| 0.5 mg Ranibizumab+Deferred Laser | 54 Eyes | |||
| 0.5 mg Ranibizumab+Deferred Laser | 52 Eyes | |||
| 0.5 mg Ranibizumab+Prompt Laser | 3 Eyes | |||
| 0.5 mg Ranibizumab+Prompt Laser | 57 Eyes | |||
| 0.5 mg Ranibizumab+Prompt Laser | 38 Eyes | |||
| 0.5 mg Ranibizumab+Prompt Laser | 34 Eyes | |||
| 0.5 mg Ranibizumab+Prompt Laser | 38 Eyes | |||
| 0.5 mg Ranibizumab+Prompt Laser | 14 Eyes | |||
| 0.5 mg Ranibizumab+Prompt Laser | 3 Eyes | |||
| 4 mg Triamcinolone+Prompt Laser | 12 Eyes | |||
| 4 mg Triamcinolone+Prompt Laser | 15 Eyes | |||
| 4 mg Triamcinolone+Prompt Laser | 22 Eyes | |||
| 4 mg Triamcinolone+Prompt Laser | 32 Eyes | |||
| 4 mg Triamcinolone+Prompt Laser | 54 Eyes | |||
| 4 mg Triamcinolone+Prompt Laser | 39 Eyes | |||
| 4 mg Triamcinolone+Prompt Laser | 12 Eyes | |||
| Sham+Prompt Laser | 38 Eyes | |||
| Sham+Prompt Laser | 67 Eyes | |||
| Sham+Prompt Laser | 23 Eyes | |||
| Sham+Prompt Laser | 16 Eyes | |||
| Sham+Prompt Laser | 86 Eyes | |||
| Sham+Prompt Laser | 43 Eyes | |||
| Sham+Prompt Laser | 20 Eyes | |||
| NCT00444600 LRT for DME | Diabetic Retinopathy | Mean Change in Visual Acuity (Letters) From Baseline to 1 Year Adjusted for Baseline Visual Acuity from baseline to 1 Year | 0.5 mg Ranibizumab+Deferred Laser | 9 Letters (±12 Standard Deviation) |
| 0.5 mg Ranibizumab+Prompt Laser | 9 Letters (±11 Standard Deviation) | |||
| 4 mg Triamcinolone+Prompt Laser | 4 Letters (±13 Standard Deviation) | |||
| Sham+Prompt Laser | 3 Letters (±13 Standard Deviation) | |||
| NCT00445003 LRTforDME+PRP | Diabetic Retinopathy | Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 14 Weeks baseline to 14 weeks | 0.5mg Ranibizumab | 1 Letter Score (±11 Standard Deviation) |
| 4-mg Triamcinolone Acetonided | 2 Letter Score (±11 Standard Deviation) | |||
| Sham Injection | -4 Letter Score (±14 Standard Deviation) | |||
| NCT00473330 RISE | Macular Edema | Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24 Baseline to Month 24 | Ranibizumab 0.3 mg | 44.8 Percentage of patients |
| Ranibizumab 0.5 mg | 39.2 Percentage of patients | |||
| Sham Injection | 18.1 Percentage of patients | |||
| NCT00473382 RIDE | Macular Edema | Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24 Baseline to Month 24 | Ranibizumab 0.3 mg | 33.6 Percentage of patients |
| Ranibizumab 0.5 mg | 45.7 Percentage of patients | |||
| Sham Injection | 12.3 Percentage of patients | |||
| NCT00485836 CRUISE | Macular Edema | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months Baseline and 6 months | Ranibizumab Injection 0.3 mg | 47.4 Units on a scale (±14.8 Standard Deviation) |
| Ranibizumab Injection 0.3 mg | 12.7 Units on a scale (±15.9 Standard Deviation) | |||
| Ranibizumab Injection 0.5 mg | 14.9 Units on a scale (±13.2 Standard Deviation) | |||
| Ranibizumab Injection 0.5 mg | 48.1 Units on a scale (±14.6 Standard Deviation) | |||
| Sham Injection | 0.8 Units on a scale (±16.2 Standard Deviation) | |||
| Sham Injection | 49.2 Units on a scale (±14.7 Standard Deviation) | |||
| NCT00486018 BRAVO | Macular Edema | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months Baseline and 6 months | Ranibizumab Injection 0.3 mg | 16.6 Units on a scale (±11.0 Standard Deviation) |
| Ranibizumab Injection 0.3 mg | 56.0 Units on a scale (±12.1 Standard Deviation) | |||
| Ranibizumab Injection 0.5 mg | 53.0 Units on a scale (±12.5 Standard Deviation) | |||
| Ranibizumab Injection 0.5 mg | 18.3 Units on a scale (±13.2 Standard Deviation) | |||
| Sham Injection | 7.3 Units on a scale (±13.0 Standard Deviation) | |||
| Sham Injection | 54.7 Units on a scale (±12.2 Standard Deviation) | |||
| NCT00509795 VIEW1 | Macular Degeneration | Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) Baseline and at week 52 | IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4 | 95.9 percentage of patients |
| IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 | 95.1 percentage of patients | |||
| IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8 | 95.1 percentage of patients | |||
| Ranibizumab 0.5mg Q4 | 94.4 percentage of patients | |||
| Total | 95.1 percentage of patients | |||
| NCT00593450 | Macular Degeneration | Change From Baseline in Visual-acuity Score (Continuous) Baseline and 1 Year | 1-Lucentis Monthly | 8.5 No. of Letters (±14.1 Standard Deviation) |
| 2-Avastin Monthly | 8.0 No. of Letters (±15.8 Standard Deviation) | |||
| 3-Lucentis as Needed | 6.8 No. of Letters (±13.1 Standard Deviation) | |||
| 4-Avastin as Needed | 5.9 No. of Letters (±15.7 Standard Deviation) | |||
| NCT00626782 | Glaucoma | Adverse Events 12 months | Treatment 1 (Ranibizumab 0.5mg) | 100 percentage of participants |
| Treatment 2 (Mitomycin C 0.4 mg/ml) | 16.67 percentage of participants | |||
| NCT00637377 VIEW 2 | Macular Degeneration | Percentage of Participants Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) At week 52 | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4 | 96.27 Percentage of participants |
| Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4 | 95.62 Percentage of participants | |||
| Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8 | 95.56 Percentage of participants | |||
| Ranibizumab 0.5mg Q4 | 94.42 Percentage of participants | |||
| NCT00680225 | Uveal Melanoma | Mean Tumor Thickness 12 mo | Lucentis Injection | 2.91 mm |
| NCT00687804 RESTORE | Edema | Core Study: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12 Baseline through the end of study (Month 12) | Laser | 0.8 Letters (±8.56 Standard Deviation) |
| Laser | 63.4 Letters (±12.26 Standard Deviation) | |||
| Laser | 62.6 Letters (±11.01 Standard Deviation) | |||
| Ranibizumab 0.5 mg | 70.8 Letters (±10.53 Standard Deviation) | |||
| Ranibizumab 0.5 mg | 6.1 Letters (±6.43 Standard Deviation) | |||
| Ranibizumab 0.5 mg | 64.7 Letters (±10.07 Standard Deviation) | |||
| Ranibizumab 0.5 mg + Laser | 5.9 Letters (±7.92 Standard Deviation) | |||
| Ranibizumab 0.5 mg + Laser | 69.2 Letters (±11.44 Standard Deviation) | |||
| Ranibizumab 0.5 mg + Laser | 63.4 Letters (±9.99 Standard Deviation) | |||
| NCT00687804 RESTORE | Edema | Extension Study: Percentage of Participants With Non-Ocular Adverse Events (AEs) in the 24 Month Extension Study Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months] | Laser With Ranibizumab in Extension | 37.3 Percentage of participants |
| Laser With Ranibizumab in Extension | 71.2 Percentage of participants | |||
| Laser Without Ranibizumab in Extension | 13.3 Percentage of participants | |||
| Laser Without Ranibizumab in Extension | 73.3 Percentage of participants | |||
| Ranibizumab 0.5 mg | 27.7 Percentage of participants | |||
| Ranibizumab 0.5 mg | 73.5 Percentage of participants | |||
| Ranibizumab 0.5 mg + Laser | 30.1 Percentage of participants | |||
| Ranibizumab 0.5 mg + Laser | 73.5 Percentage of participants | |||
| NCT00687804 RESTORE | Edema | Extension Study: Percentage of Participants With Ocular Adverse Events (AEs) in the Study Eye in the 24 Month Extension Study Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months] | Laser With Ranibizumab in Extension | 1.7 Percentage of participants |
| Laser With Ranibizumab in Extension | 52.5 Percentage of participants | |||
| Laser Without Ranibizumab in Extension | 0.0 Percentage of participants | |||
| Laser Without Ranibizumab in Extension | 40.0 Percentage of participants | |||
| Ranibizumab 0.5 mg | 56.6 Percentage of participants | |||
| Ranibizumab 0.5 mg | 2.4 Percentage of participants | |||
| Ranibizumab 0.5 mg + Laser | 56.6 Percentage of participants | |||
| Ranibizumab 0.5 mg + Laser | 1.2 Percentage of participants | |||
| NCT00764738 | — | Microperimetry Mean Sensitivity One Year | Monthly Ranibizumab | 6.7 dB (±0.7 Standard Error) |
| Monthly Ranibizumab | 5.5 dB (±0.8 Standard Error) | |||
| PRN Ranibizumab | 5.1 dB (±0.7 Standard Error) | |||
| PRN Ranibizumab | 7.3 dB (±0.8 Standard Error) | |||
| Ranibizumab 0.5 mg | 7.3 dB (±0.7 Standard Error) | |||
| Ranibizumab 0.5 mg | 5.7 dB (±0.7 Standard Error) | |||
| Ranibizumab 2.0 mg | 6.6 dB (±1.0 Standard Error) | |||
| Ranibizumab 2.0 mg | 4.6 dB (±0.8 Standard Error) | |||
| NCT00764738 | — | Multifocal Electroretinography N1-P1 Amplitude One Year | Monthly Ranibizumab | 3.6 nV/deg^2 (±0.4 Standard Error) |
| Monthly Ranibizumab | 3.4 nV/deg^2 (±0.4 Standard Error) | |||
| PRN Ranibizumab | 5.3 nV/deg^2 (±0.4 Standard Error) | |||
| PRN Ranibizumab | 4.7 nV/deg^2 (±0.4 Standard Error) | |||
| Ranibizumab 0.5 mg | 4.9 nV/deg^2 (±0.4 Standard Error) | |||
| Ranibizumab 0.5 mg | 4.4 nV/deg^2 (±0.4 Standard Error) | |||
| Ranibizumab 2.0 mg | 3.6 nV/deg^2 (±0.4 Standard Error) | |||
| Ranibizumab 2.0 mg | 4.0 nV/deg^2 (±0.4 Standard Error) | |||
| NCT00891735 HARBOR | Macular Degeneration | Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 Baseline to Month 12 | Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN]) | 8.2 Letters (±13.3 Standard Deviation) |
| Ranibizumab 0.5 mg Monthly | 10.1 Letters (±13.3 Standard Deviation) | |||
| Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN]) | 8.6 Letters (±13.8 Standard Deviation) | |||
| Ranibizumab 2.0 mg Monthly | 9.2 Letters (±14.6 Standard Deviation) | |||
| NCT00989989 REVEAL | Edema | Average Change From Baseline of Best-Corrected Visual Acuity (BCVA) Over 12 Months (From Month 1 to Month 12 Compared to Baseline) 12 months | Adjunctive Treatment | 5.7 Letters (±7.20 Standard Deviation) |
| Laser Control | 1.4 Letters (±6.49 Standard Deviation) | |||
| Monotherapy Treatment | 5.9 Letters (±6.02 Standard Deviation) | |||
| NCT00996437 N | Retinal Diseases | Safety (Injected-related, Ocular Drug-related and Systemic Drug-related) Baseline to 16 weeks | Ranibizumab | 13 participants |
| Ranibizumab | 4 participants | |||
| Ranibizumab | 0 participants | |||
| Ranibizumab | 0 participants | |||
| Ranibizumab | 10 participants | |||
| Ranibizumab | 1 participants | |||
| Ranibizumab | 1 participants | |||
| Ranibizumab | 0 participants | |||
| Ranibizumab | 8 participants | |||
| Ranibizumab | 16 participants | |||
| Ranibizumab | 8 participants | |||
| Saline Injection | 0 participants | |||
| Saline Injection | 14 participants | |||
| Saline Injection | 1 participants | |||
| Saline Injection | 19 participants | |||
| Saline Injection | 11 participants | |||
| Saline Injection | 4 participants | |||
| Saline Injection | 4 participants | |||
| Saline Injection | 11 participants | |||
| Saline Injection | 1 participants | |||
| Saline Injection | 2 participants | |||
| Saline Injection | 23 participants | |||
| NCT00996437 N | Retinal Diseases | Treatment or "Failure" Defined as Vitrectomy within 112 days of randomization | Ranibizumab | 12 percentage of participants |
| Saline Injection | 17 percentage of participants | |||
| NCT01131585 RELATION | — | Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12 12 months | Active Laser Photocoagulation and Ranibizumab | 6.5 Letters (±8.6 Standard Deviation) |
| Active Laser Photocoagulation and Sham Injection | 1.4 Letters (±7.3 Standard Deviation) | |||
| NCT01135914 RESPOND | Macular Edema | Mean Change From Baseline in Best Corrected Visual Acuity- (BCVA) at Month 12 Baseline and 12 months | Combination Therapy | 8.2 Letters (±9.20 Standard Deviation) |
| Laser Monotherapy | 0.3 Letters (±12.47 Standard Deviation) | |||
| Ranibizumab Monotherapy | 8.9 Letters (±7.78 Standard Deviation) | |||
| NCT01171976 RETAIN | — | Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 12 Baseline to Month 12 | PRN Ranibizumab 0.5 mg | 71.32 Letters (±9.984 Standard Deviation) |
| PRN Ranibizumab 0.5 mg | 65.1 Letters (±10.08 Standard Deviation) | |||
| PRN Ranibizumab 0.5 mg | 6.20 Letters (±6.005 Standard Deviation) | |||
| TE Ranibizumab 0.5 mg Alone | 70.28 Letters (±10.284 Standard Deviation) | |||
| TE Ranibizumab 0.5 mg Alone | 6.14 Letters (±5.717 Standard Deviation) | |||
| TE Ranibizumab 0.5 mg Alone | 64.1 Letters (±10.52 Standard Deviation) | |||
| TE Ranibizumad 0.5 mg and Laser | 5.91 Letters (±5.532 Standard Deviation) | |||
| TE Ranibizumad 0.5 mg and Laser | 62.3 Letters (±11.50 Standard Deviation) | |||
| TE Ranibizumad 0.5 mg and Laser | 68.25 Letters (±11.057 Standard Deviation) | |||
| NCT01198327 RETAIN | Retinal Vein Occlusion | Incidence of Serious Adverse Events. 24 mos | Ranibizumab as Needed | 17 number of serious adverse events |
| NCT01217944 | Choroidal Neovascularization | Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye Baseline, Month 1 through Month 3 | 0.5 mg Ranibizumab Driven by Stabilization Criteria | 66.0 Letters (±12.98 Standard Deviation) |
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | 55.4 Letters (±13.43 Standard Deviation) | |||
| 0.5mg Ranibizumab Driven by Disease Activity | 66.4 Letters (±12.28 Standard Deviation) | |||
| 0.5mg Ranibizumab Driven by Disease Activity | 55.8 Letters (±12.59 Standard Deviation) | |||
| Verteporfin PDT | 54.7 Letters (±13.84 Standard Deviation) | |||
| Verteporfin PDT | 56.9 Letters (±14.49 Standard Deviation) | |||
| NCT01396057 COMRADE-B | Macular Edema | Mean Average Best Corrected Visual Acuity (BCVA) Change From Month 1 Through Month 6 to Baseline Baseline, month 6 | Dexamethasone | 10.1 Letters (±9.5 Standard Deviation) |
| Ranibizumab | 14.9 Letters (±9.9 Standard Deviation) | |||
| NCT01396083 COMRADE-C | Macular Edema | Mean Average BCVA Change From Month 1 Through Month 6 to Baseline Baseline, month 6 | Dexamethasone | 4.8 Letters (±16.2 Standard Deviation) |
| Ranibizumab | 14.6 Letters (±11.8 Standard Deviation) | |||
| NCT01402544 COMPASS | Macular Degeneration | Number of Patients That Achieve Their Pre-wet Age-Related Macular Degeneration (AMD) Baseline Visual Acuity Within 12 Months Baseline, Month 6 and Month 12 | Ranibizumab 0.5 mg | 3 Participants |
| NCT01489189 Protocol S | — | Mean Change in Visual Acuity From Baseline 2-years | Anti-VEGF+Deferred PRP | 2.8 letters |
| Prompt PRP | 0.2 letters | |||
| NCT01535261 CRYSTAL | Macular Edema | Mean Change in Best Corrected Visual Acuity (BCVA) at Month 12 Compared to Baseline Baseline to month 12 | Ranibizumab Arm | 12.3 Letters (±16.72 Standard Deviation) |
| NCT01599650 BRIGHTER | Macular Edema | Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) Baseline, 6 Months | 1-ranibizumab Monotherapy | 14.8 letters (±10.70 Standard Deviation) |
| 1-ranibizumab Monotherapy | 59.5 letters (±11.78 Standard Deviation) | |||
| 1-ranibizumab Monotherapy | 74.3 letters (±12.27 Standard Deviation) | |||
| 2-ranibizumab With Laser | 56.6 letters (±13.19 Standard Deviation) | |||
| 2-ranibizumab With Laser | 14.8 letters (±11.13 Standard Deviation) | |||
| 2-ranibizumab With Laser | 71.4 letters (±14.43 Standard Deviation) | |||
| 3-laser Monotherapy | 56.8 letters (±13.86 Standard Deviation) | |||
| 3-laser Monotherapy | 62.8 letters (±14.08 Standard Deviation) | |||
| 3-laser Monotherapy | 6.0 letters (±14.27 Standard Deviation) | |||
| NCT01627249 Protocol T | — | Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score <69 Baseline to 1-year | Aflibercept | 18.9 units on a scale (±11.5 Standard Deviation) |
| Bevacizumab | 11.8 units on a scale (±12.0 Standard Deviation) | |||
| Ranibizumab | 14.2 units on a scale (±10.6 Standard Deviation) | |||
| NCT01627249 Protocol T | — | Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score 78-69 Baseline to 1-year | Aflibercept | 8.0 units on a scale (±7.6 Standard Deviation) |
| Bevacizumab | 7.5 units on a scale (±7.4 Standard Deviation) | |||
| Ranibizumab | 8.3 units on a scale (±6.8 Standard Deviation) | |||
| NCT01627249 Protocol T | — | Overall Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year Baseline to 1-year | Aflibercept | 13.3 units on a scale (±11.1 Standard Deviation) |
| Bevacizumab | 9.7 units on a scale (±10.1 Standard Deviation) | |||
| Ranibizumab | 11.2 units on a scale (±9.4 Standard Deviation) | |||
| NCT01661946 | Macular Edema | Maximum Concentration (Cmax) of Anti-VEGF Antibody 1 month | Bevacizumab | 9.56 ng/mL (±2.50 Standard Error) |
| Ranibizumab | 25.22 ng/mL (±7.59 Standard Error) | |||
| NCT01748292 T-REX | Macular Degeneration | Mean Change in BCVA by ETDRS Letter Score From Baseline 6, 12, 18, 24, 30, and 36 months | Monthly IVT Ranibizumab | 8.6 ETDRS BCVA Letters (±2.8 Standard Error) |
| Monthly IVT Ranibizumab | 10.5 ETDRS BCVA Letters (±1.3 Standard Error) | |||
| Monthly IVT Ranibizumab | 9.2 ETDRS BCVA Letters (±1.4 Standard Error) | |||
| Monthly IVT Ranibizumab | 10.4 ETDRS BCVA Letters (±1.9 Standard Error) | |||
| Monthly IVT Ranibizumab | 10.5 ETDRS BCVA Letters (±1.9 Standard Error) | |||
| Monthly IVT Ranibizumab | 9.7 ETDRS BCVA Letters (±2.3 Standard Error) | |||
| Treat and Extend IVT Ranibizumab | 8.7 ETDRS BCVA Letters (±3.6 Standard Error) | |||
| Treat and Extend IVT Ranibizumab | .95 ETDRS BCVA Letters (±4.4 Standard Error) | |||
| Treat and Extend IVT Ranibizumab | 10.5 ETDRS BCVA Letters (±2.0 Standard Error) | |||
| Treat and Extend IVT Ranibizumab | 7.3 ETDRS BCVA Letters (±1.9 Standard Error) | |||
| Treat and Extend IVT Ranibizumab | 9.0 ETDRS BCVA Letters (±3.2 Standard Error) | |||
| Treat and Extend IVT Ranibizumab | 4.1 ETDRS BCVA Letters (±4.0 Standard Error) | |||
| NCT01780935 OCTAVE | — | Average Best-corrected Visual Acuity (BCVA) (Letters) Change up to Month 12 up to Month 12 | RBZ 0.5 mg: VA and/or OCT (Group II) | 1.0 Letters correctly read (±7.25 Standard Deviation) |
| RBZ 0.5 mg: VA Only (Group I) | 0.1 Letters correctly read (±6.79 Standard Deviation) | |||
| NCT01840410 | Choroidal Neovascularization | Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2 Baseline, Month 2 | Ranibizumab | 9.5 letters (±0.95 Standard Error) |
| Sham Control | -0.4 letters (±1.16 Standard Error) | |||
| NCT01846299 | Macular Edema | Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye Baseline, Month 2 | Ranibizumab | 5.7 letters (±0.81 Standard Error) |
| Sham With Ranibizumab | 2.9 letters (±0.89 Standard Error) | |||
| NCT01908816 ECLIPSE | Macular Edema | Number of Participants With Adverse Events as a Measure of Safety and Tolerability 24 months | CNV (Choroidal Neovascularization) | 1 Participants |
| CNV (Choroidal Neovascularization) | 11 Participants | |||
| CNV (Choroidal Neovascularization) | 2 Participants | |||
| ME (Macular Edema) | 21 Participants | |||
| ME (Macular Edema) | 0 Participants | |||
| ME (Macular Edema) | 15 Participants | |||
| PDR/V | 14 Participants | |||
| PDR/V | 0 Participants | |||
| PDR/V | 1 Participants | |||
| RI/NVG (Rubeosis Iridis and Neovacular Glaucoma) | 7 Participants | |||
| RI/NVG (Rubeosis Iridis and Neovacular Glaucoma) | 1 Participants | |||
| RI/NVG (Rubeosis Iridis and Neovacular Glaucoma) | 31 Participants | |||
| NCT01922102 Brilliance | Choroidal Neovascularization | Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 3 From Baseline to Month 3 | Group I | 53.7 ETDRS letters (±12.65 Standard Deviation) |
| Group I | 63.1 ETDRS letters (±12.80 Standard Deviation) | |||
| Group II | 63.9 ETDRS letters (±13.28 Standard Deviation) | |||
| Group II | 54.2 ETDRS letters (±13.01 Standard Deviation) | |||
| Group III | 52.6 ETDRS letters (±12.29 Standard Deviation) | |||
| Group III | 57.1 ETDRS letters (±13.21 Standard Deviation) | |||
| NCT01940900 | Macular Degeneration | Mean Change in Visual Acuity From Baseline to 12 Months 12 Months | E10030 + Ranibizumab | 9.91 letters (±0.88 Standard Error) |
| Sham + Ranibizumab | 10.36 letters (±0.87 Standard Error) | |||
| NCT01944839 | Macular Degeneration | Mean Change in Visual Acuity From Baseline to 12 Months 12 Months | E10030 + Ranibizumab | 10.74 letters (±0.86 Standard Error) |
| Sham + Ranibizumab | 9.82 letters (±0.86 Standard Error) | |||
| NCT01948830 TREND | Macular Degeneration | Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12 Baseline to month 12 | Group I Ranibizumab 0.5 mg TER | 6.2 Letters (EDTRS) (±0.70 Standard Error) |
| Group II Ranibizumab 0.5 mg Monthly | 8.1 Letters (EDTRS) (±0.70 Standard Error) | |||
| NCT01976312 Camellia | Macular Edema | Average Change in Visual Acuity (Letters) From Baseline to Month 1 Through Month 3 Baseline, 3 Months | Ranibizumab 0.5 mg | 11.3 Letters (±10.77 Standard Deviation) |
| Sham Injection | -2.7 Letters (±13.92 Standard Deviation) | |||
| NCT01976338 Blossom | Macular Edema | Average Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 6 Baseline to Month 1 through Month 6 | Ranibizumab 0.5 mg | 12.5 Letters (±8.34 Standard Deviation) |
| Sham Injection | 5.0 Letters (±9.18 Standard Deviation) | |||
| NCT02034006 OLIMPIC | Choroidal Neovascularization | Change in Central Subfield Thickness (CSFT) Screening, Month 2, Month 6, Month 12 | Ranibizumab: Re-treated Once | -34.28 micromilimeter(um) (±78.01 Standard Deviation) |
| Ranibizumab: Re-treated Once | -15.83 micromilimeter(um) (±70.74 Standard Deviation) | |||
| Ranibizumab: Re-treated Once | 8.64 micromilimeter(um) (±76.79 Standard Deviation) | |||
| Ranibizumab: Treated Once | 1.29 micromilimeter(um) (±62.55 Standard Deviation) | |||
| Ranibizumab: Treated Once | -11.04 micromilimeter(um) (±61.06 Standard Deviation) | |||
| Ranibizumab: Treated Once | -16.15 micromilimeter(um) (±86.65 Standard Deviation) | |||
| NCT02034006 OLIMPIC | Choroidal Neovascularization | Change in Central Subfield Volume (CSV) Screening, Month 2, Month 6, Month 12 | Ranibizumab: Re-treated Once | -0.02 mm^3 (±0.06 Standard Deviation) |
| Ranibizumab: Re-treated Once | -0.01 mm^3 (±0.07 Standard Deviation) | |||
| Ranibizumab: Re-treated Once | 0.01 mm^3 (±0.08 Standard Deviation) | |||
| Ranibizumab: Treated Once | -0.00 mm^3 (±0.04 Standard Deviation) | |||
| Ranibizumab: Treated Once | -0.00 mm^3 (±0.04 Standard Deviation) | |||
| Ranibizumab: Treated Once | -0.02 mm^3 (±0.06 Standard Deviation) | |||
| NCT02034006 OLIMPIC | Choroidal Neovascularization | Number of Patients in Different Categories of Changes From Baseline in BCVA Baseline, Month 1, Month 2, Month 3, Month 6, Month 12 | Ranibizumab: Re-treated Once | 97 Patients |
| Ranibizumab: Re-treated Once | 92 Patients | |||
| Ranibizumab: Re-treated Once | 29 Patients | |||
| Ranibizumab: Re-treated Once | 92 Patients | |||
| Ranibizumab: Re-treated Once | 30 Patients | |||
| Ranibizumab: Re-treated Once | 94 Patients | |||
| Ranibizumab: Re-treated Once | 9 Patients | |||
| Ranibizumab: Re-treated Once | 95 Patients | |||
| Ranibizumab: Re-treated Once | 25 Patients | |||
| Ranibizumab: Re-treated Once | 9 Patients | |||
| Ranibizumab: Re-treated Once | 15 Patients | |||
| Ranibizumab: Re-treated Once | 18 Patients | |||
| Ranibizumab: Re-treated Once | 7 Patients | |||
| Ranibizumab: Re-treated Once | 6 Patients | |||
| Ranibizumab: Re-treated Once | 25 Patients | |||
| Ranibizumab: Treated Once | 7 Patients | |||
| Ranibizumab: Treated Once | 51 Patients | |||
| Ranibizumab: Treated Once | 3 Patients | |||
| Ranibizumab: Treated Once | 48 Patients | |||
| Ranibizumab: Treated Once | 9 Patients | |||
| Ranibizumab: Treated Once | 5 Patients | |||
| Ranibizumab: Treated Once | 52 Patients | |||
| Ranibizumab: Treated Once | 8 Patients | |||
| Ranibizumab: Treated Once | 3 Patients | |||
| Ranibizumab: Treated Once | 50 Patients | |||
| Ranibizumab: Treated Once | 9 Patients | |||
| Ranibizumab: Treated Once | 6 Patients | |||
| Ranibizumab: Treated Once | 51 Patients | |||
| Ranibizumab: Treated Once | 8 Patients | |||
| Ranibizumab: Treated Once | 9 Patients | |||
| NCT02034006 OLIMPIC | Choroidal Neovascularization | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 10 Letters Baseline, Month 1, Month 2, Month 3, Month 6, Month 12 | Ranibizumab: Re-treated Once | 27 Patients |
| Ranibizumab: Re-treated Once | 44 Patients | |||
| Ranibizumab: Re-treated Once | 48 Patients | |||
| Ranibizumab: Re-treated Once | 42 Patients | |||
| Ranibizumab: Re-treated Once | 50 Patients | |||
| Ranibizumab: Re-treated Once | 53 Patients | |||
| Ranibizumab: Re-treated Once | 41 Patients | |||
| Ranibizumab: Re-treated Once | 55 Patients | |||
| Ranibizumab: Re-treated Once | 70 Patients | |||
| Ranibizumab: Re-treated Once | 40 Patients | |||
| Ranibizumab: Treated Once | 23 Patients | |||
| Ranibizumab: Treated Once | 38 Patients | |||
| Ranibizumab: Treated Once | 13 Patients | |||
| Ranibizumab: Treated Once | 20 Patients | |||
| Ranibizumab: Treated Once | 30 Patients | |||
| Ranibizumab: Treated Once | 22 Patients | |||
| Ranibizumab: Treated Once | 30 Patients | |||
| Ranibizumab: Treated Once | 29 Patients | |||
| Ranibizumab: Treated Once | 19 Patients | |||
| Ranibizumab: Treated Once | 28 Patients | |||
| NCT02034006 OLIMPIC | Choroidal Neovascularization | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 5 Letters Baseline, Month 1, Month 2, Month 3, Month 6, Month 12 | Ranibizumab: Re-treated Once | 25 Patients |
| Ranibizumab: Re-treated Once | 22 Patients | |||
| Ranibizumab: Re-treated Once | 69 Patients | |||
| Ranibizumab: Re-treated Once | 74 Patients | |||
| Ranibizumab: Re-treated Once | 20 Patients | |||
| Ranibizumab: Re-treated Once | 70 Patients | |||
| Ranibizumab: Re-treated Once | 70 Patients | |||
| Ranibizumab: Re-treated Once | 23 Patients | |||
| Ranibizumab: Re-treated Once | 28 Patients | |||
| Ranibizumab: Re-treated Once | 69 Patients | |||
| Ranibizumab: Treated Once | 40 Patients | |||
| Ranibizumab: Treated Once | 38 Patients | |||
| Ranibizumab: Treated Once | 14 Patients | |||
| Ranibizumab: Treated Once | 8 Patients | |||
| Ranibizumab: Treated Once | 37 Patients | |||
| Ranibizumab: Treated Once | 15 Patients | |||
| Ranibizumab: Treated Once | 43 Patients | |||
| Ranibizumab: Treated Once | 12 Patients | |||
| Ranibizumab: Treated Once | 8 Patients | |||
| Ranibizumab: Treated Once | 37 Patients | |||
| NCT02034006 OLIMPIC | Choroidal Neovascularization | Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage Screening, Month 2, Month 6 | Ranibizumab: Re-treated Once | 1 Patients |
| Ranibizumab: Re-treated Once | 61 Patients | |||
| Ranibizumab: Re-treated Once | 73 Patients | |||
| Ranibizumab: Re-treated Once | 56 Patients | |||
| Ranibizumab: Re-treated Once | 2 Patients | |||
| Ranibizumab: Re-treated Once | 2 Patients | |||
| Ranibizumab: Re-treated Once | 121 Patients | |||
| Ranibizumab: Re-treated Once | 0 Patients | |||
| Ranibizumab: Re-treated Once | 2 Patients | |||
| Ranibizumab: Re-treated Once | 40 Patients | |||
| Ranibizumab: Treated Once | 0 Patients | |||
| Ranibizumab: Treated Once | 1 Patients | |||
| Ranibizumab: Treated Once | 4 Patients | |||
| Ranibizumab: Treated Once | 55 Patients | |||
| Ranibizumab: Treated Once | 0 Patients | |||
| Ranibizumab: Treated Once | 3 Patients | |||
| Ranibizumab: Treated Once | 58 Patients | |||
| Ranibizumab: Treated Once | 0 Patients | |||
| Ranibizumab: Treated Once | 61 Patients | |||
| Ranibizumab: Treated Once | 3 Patients | |||
| NCT02034006 OLIMPIC | Choroidal Neovascularization | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities Baseline, Month 1, Month 2, Month 3, Month 6, Month 12 | Ranibizumab: Re-treated Once | 1 Patients |
| Ranibizumab: Re-treated Once | 24 Patients | |||
| Ranibizumab: Re-treated Once | 116 Patients | |||
| Ranibizumab: Re-treated Once | 0 Patients | |||
| Ranibizumab: Re-treated Once | 18 Patients | |||
| Ranibizumab: Re-treated Once | 106 Patients | |||
| Ranibizumab: Re-treated Once | 103 Patients | |||
| Ranibizumab: Re-treated Once | 110 Patients | |||
| Ranibizumab: Re-treated Once | 2 Patients | |||
| Ranibizumab: Re-treated Once | 20 Patients | |||
| Ranibizumab: Re-treated Once | 2 Patients | |||
| Ranibizumab: Re-treated Once | 12 Patients | |||
| Ranibizumab: Re-treated Once | 2 Patients | |||
| Ranibizumab: Re-treated Once | 0 Patients | |||
| Ranibizumab: Re-treated Once | 103 Patients | |||
| Ranibizumab: Re-treated Once | 26 Patients | |||
| Ranibizumab: Re-treated Once | 27 Patients | |||
| Ranibizumab: Re-treated Once | 108 Patients | |||
| Ranibizumab: Treated Once | 59 Patients | |||
| Ranibizumab: Treated Once | 3 Patients | |||
| Ranibizumab: Treated Once | 4 Patients | |||
| Ranibizumab: Treated Once | 60 Patients | |||
| Ranibizumab: Treated Once | 61 Patients | |||
| Ranibizumab: Treated Once | 56 Patients | |||
| Ranibizumab: Treated Once | 2 Patients | |||
| Ranibizumab: Treated Once | 60 Patients | |||
| Ranibizumab: Treated Once | 61 Patients | |||
| Ranibizumab: Treated Once | 7 Patients | |||
| Ranibizumab: Treated Once | 5 Patients | |||
| Ranibizumab: Treated Once | 6 Patients | |||
| Ranibizumab: Treated Once | 7 Patients | |||
| Ranibizumab: Treated Once | 9 Patients | |||
| Ranibizumab: Treated Once | 8 Patients | |||
| Ranibizumab: Treated Once | 0 Patients | |||
| Ranibizumab: Treated Once | 7 Patients | |||
| Ranibizumab: Treated Once | 5 Patients | |||
| NCT02034006 OLIMPIC | Choroidal Neovascularization | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts Screening, Month 2, Month 6, Month 12 | Ranibizumab: Re-treated Once | 2 Patients |
| Ranibizumab: Re-treated Once | 98 Patients | |||
| Ranibizumab: Re-treated Once | 32 Patients | |||
| Ranibizumab: Re-treated Once | 0 Patients | |||
| Ranibizumab: Re-treated Once | 26 Patients | |||
| Ranibizumab: Re-treated Once | 50 Patients | |||
| Ranibizumab: Re-treated Once | 97 Patients | |||
| Ranibizumab: Re-treated Once | 79 Patients | |||
| Ranibizumab: Re-treated Once | 1 Patients | |||
| Ranibizumab: Re-treated Once | 1 Patients | |||
| Ranibizumab: Re-treated Once | 94 Patients | |||
| Ranibizumab: Re-treated Once | 27 Patients | |||
| Ranibizumab: Re-treated Once | 1 Patients | |||
| Ranibizumab: Treated Once | 60 Patients | |||
| Ranibizumab: Treated Once | 27 Patients | |||
| Ranibizumab: Treated Once | 1 Patients | |||
| Ranibizumab: Treated Once | 1 Patients | |||
| Ranibizumab: Treated Once | 3 Patients | |||
| Ranibizumab: Treated Once | 57 Patients | |||
| Ranibizumab: Treated Once | 1 Patients | |||
| Ranibizumab: Treated Once | 2 Patients | |||
| Ranibizumab: Treated Once | 41 Patients | |||
| Ranibizumab: Treated Once | 57 Patients | |||
| Ranibizumab: Treated Once | 0 Patients | |||
| Ranibizumab: Treated Once | 1 Patients | |||
| Ranibizumab: Treated Once | 2 Patients | |||
| NCT02034006 OLIMPIC | Choroidal Neovascularization | Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid Screening, Month 2, Month 6, Month 12 | Ranibizumab: Re-treated Once | 77 Patients |
| Ranibizumab: Re-treated Once | 38 Patients | |||
| Ranibizumab: Re-treated Once | 85 Patients | |||
| Ranibizumab: Re-treated Once | 2 Patients | |||
| Ranibizumab: Re-treated Once | 2 Patients | |||
| Ranibizumab: Re-treated Once | 90 Patients | |||
| Ranibizumab: Re-treated Once | 37 Patients | |||
| Ranibizumab: Re-treated Once | 50 Patients | |||
| Ranibizumab: Re-treated Once | 2 Patients | |||
| Ranibizumab: Re-treated Once | 26 Patients | |||
| Ranibizumab: Re-treated Once | 96 Patients | |||
| Ranibizumab: Re-treated Once | 3 Patients | |||
| Ranibizumab: Treated Once | 19 Patients | |||
| Ranibizumab: Treated Once | 1 Patients | |||
| Ranibizumab: Treated Once | 49 Patients | |||
| Ranibizumab: Treated Once | 58 Patients | |||
| Ranibizumab: Treated Once | 1 Patients | |||
| Ranibizumab: Treated Once | 1 Patients | |||
| Ranibizumab: Treated Once | 7 Patients | |||
| Ranibizumab: Treated Once | 1 Patients | |||
| Ranibizumab: Treated Once | 55 Patients | |||
| Ranibizumab: Treated Once | 57 Patients | |||
| Ranibizumab: Treated Once | 2 Patients | |||
| Ranibizumab: Treated Once | 2 Patients | |||
| NCT02034006 OLIMPIC | Choroidal Neovascularization | Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema Screening, Month 2, Month 6, Month 12 | Ranibizumab: Re-treated Once | 15 Patients |
| Ranibizumab: Re-treated Once | 108 Patients | |||
| Ranibizumab: Re-treated Once | 1 Patients | |||
| Ranibizumab: Re-treated Once | 1 Patients | |||
| Ranibizumab: Re-treated Once | 24 Patients | |||
| Ranibizumab: Re-treated Once | 2 Patients | |||
| Ranibizumab: Re-treated Once | 103 Patients | |||
| Ranibizumab: Re-treated Once | 65 Patients | |||
| Ranibizumab: Re-treated Once | 101 Patients | |||
| Ranibizumab: Re-treated Once | 24 Patients | |||
| Ranibizumab: Re-treated Once | 1 Patients | |||
| Ranibizumab: Re-treated Once | 63 Patients | |||
| Ranibizumab: Treated Once | 1 Patients | |||
| Ranibizumab: Treated Once | 1 Patients | |||
| Ranibizumab: Treated Once | 4 Patients | |||
| Ranibizumab: Treated Once | 56 Patients | |||
| Ranibizumab: Treated Once | 2 Patients | |||
| Ranibizumab: Treated Once | 57 Patients | |||
| Ranibizumab: Treated Once | 1 Patients | |||
| Ranibizumab: Treated Once | 3 Patients | |||
| Ranibizumab: Treated Once | 59 Patients | |||
| Ranibizumab: Treated Once | 3 Patients | |||
| Ranibizumab: Treated Once | 28 Patients | |||
| Ranibizumab: Treated Once | 38 Patients | |||
| NCT02034006 OLIMPIC | Choroidal Neovascularization | Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid Screening, Month 2, Month 6, Month 12 | Ranibizumab: Re-treated Once | 3 Patients |
| Ranibizumab: Re-treated Once | 14 Patients | |||
| Ranibizumab: Re-treated Once | 113 Patients | |||
| Ranibizumab: Re-treated Once | 3 Patients | |||
| Ranibizumab: Re-treated Once | 8 Patients | |||
| Ranibizumab: Re-treated Once | 61 Patients | |||
| Ranibizumab: Re-treated Once | 65 Patients | |||
| Ranibizumab: Re-treated Once | 3 Patients | |||
| Ranibizumab: Re-treated Once | 17 Patients | |||
| Ranibizumab: Re-treated Once | 108 Patients | |||
| Ranibizumab: Re-treated Once | 4 Patients | |||
| Ranibizumab: Re-treated Once | 109 Patients | |||
| Ranibizumab: Treated Once | 58 Patients | |||
| Ranibizumab: Treated Once | 1 Patients | |||
| Ranibizumab: Treated Once | 3 Patients | |||
| Ranibizumab: Treated Once | 58 Patients | |||
| Ranibizumab: Treated Once | 0 Patients | |||
| Ranibizumab: Treated Once | 2 Patients | |||
| Ranibizumab: Treated Once | 60 Patients | |||
| Ranibizumab: Treated Once | 0 Patients | |||
| Ranibizumab: Treated Once | 1 Patients | |||
| Ranibizumab: Treated Once | 2 Patients | |||
| Ranibizumab: Treated Once | 43 Patients | |||
| Ranibizumab: Treated Once | 25 Patients | |||
| NCT02259088 REFINE | Macular Edema | Mean Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) (Letters) to Month 1 Through 12 Baseline, Monthly from Month 1 through Month 12 | Laser | 1.1 letters (±7.73 Standard Deviation) |
| Ranibizumab (RFB002) | 6.8 letters (±6.58 Standard Deviation) | |||
| NCT02375971 RAINBOW | Retinopathy of Prematurity | Percentage of Participants With Absence of Active ROP and Absence of Unfavorable Structural Outcomes in Both Eyes at Week 24 Week 24 | Laser Therapy | 66.2 Percentage of Participants |
| Ranibizumab 0.1 mg | 75.0 Percentage of Participants | |||
| Ranibizumab 0.2 mg | 80.0 Percentage of Participants | |||
| NCT02462486 | Macular Degeneration | Percentage of Participants With Stable Vision at Week 52 Baseline to Week 52 | Abicipar Pegol 2 mg (2Q12) | 91.3 percentage of participants |
| Abicipar Pegol 2 mg (2Q8) | 94.8 percentage of participants | |||
| Ranibizumab (rQ4) | 96.0 percentage of participants | |||
| NCT02462928 CEDAR | Macular Degeneration | Percentage of Participants With Stable Vision at Week 52 Baseline to Week 52 | Abicipar Pegol 2 mg (2Q12) | 91.2 percentage of participants |
| Abicipar Pegol 2 mg (2Q8) | 91.7 percentage of participants | |||
| Ranibizumab 0.5 mg (rQ4) | 95.5 percentage of participants | |||
| NCT02611778 COLUMBUS-AMD | Macular Degeneration | Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 8 Weeks Baseline and Week 8 | FYB201 | 5.1 letters (±7.52 Standard Deviation) |
| Lucentis | 5.6 letters (±8.63 Standard Deviation) | |||
| Total | 5.4 letters (±8.10 Standard Deviation) | |||
| NCT02623426 MERIT | Macular Edema | Proportion of Baseline Central Subfield Thickness Observed at 12 Weeks At 12-week visit | Intravitreal Methotrexate 400 µg in 0.1 mL 0.9% Sodium Chloride Solution, Preservative-free | 0.88 Proportion of baseline retinal thickness |
| Intravitreal Ranibizumab (Lucentis) 0.5 mg in 0.05 mL | 0.79 Proportion of baseline retinal thickness | |||
| Ozurdex (0.7 mg Dexamethasone Pellet) Delivered Via Intravitreal Injection | 0.65 Proportion of baseline retinal thickness | |||
| NCT02640664 RainbowExt | Retinopathy of Prematurity | Visual Acuity (VA) of the Better-seeing Eye at the Participant's Fifth Birthday Visit - Comparison Between Treatment Arms at the participant's fifth birthday visit (maximum 5 years and 4 months post core baseline visit) | Laser Therapy | 62.1 Score on a scale (±2.18 Standard Error) |
| Ranibizumab 0.1 mg | 64.6 Score on a scale (±2.00 Standard Error) | |||
| Ranibizumab 0.2 mg | 66.8 Score on a scale (±1.95 Standard Error) | |||
| NCT02698566 | Macular Edema | Percentage of PFS Usage Errors on Essential Tasks Day 1 | Ranibizumab PFS | 0 percentage of usage errors |
| NCT02698566 | Macular Edema | Percentage of PFS Usage Errors on Safety Critical Tasks Day 1 | Ranibizumab PFS | 0 percentage of usage errors |
| NCT02698566 | Macular Edema | Percentage of Successful Task Completions Day 1 | Ranibizumab PFS | 100 percentage of tasks |
| Ranibizumab PFS | 100 percentage of tasks | |||
| Ranibizumab PFS | 100 percentage of tasks | |||
| Ranibizumab PFS | 100 percentage of tasks | |||
| Ranibizumab PFS | 100 percentage of tasks | |||
| Ranibizumab PFS | 100 percentage of tasks | |||
| Ranibizumab PFS | 100 percentage of tasks | |||
| Ranibizumab PFS | 100 percentage of tasks | |||
| Ranibizumab PFS | 100 percentage of tasks | |||
| Ranibizumab PFS | 100 percentage of tasks | |||
| Ranibizumab PFS | 100 percentage of tasks | |||
| Ranibizumab PFS | 100 percentage of tasks | |||
| NCT03150589 | Macular Degeneration | Change From Baseline in Best Corrected Visual Acuity (BCVA) Baseline and Week 8 | Lucentis (Ranibizumab) | 7.08 letters (±0.51 Standard Error) |
| SB11 (Proposed Ranibizumab Biosimilar) | 6.26 letters (±0.51 Standard Error) | |||
| NCT03150589 | Macular Degeneration | Change From Baseline in Central Subfield Thickness (CST) Baseline and Week 4 | Lucentis (Ranibizumab) | -100.05 μm (±4.64 Standard Error) |
| SB11 (Proposed Ranibizumab Biosimilar) | -108.40 μm (±4.65 Standard Error) | |||
| NCT03677934 Archway | — | Change From Baseline in Best-Corrected Visual Acuity (BCVA) Score at the Average of Week 36 and Week 40, as Assessed Using the ETDRS Visual Acuity Chart at a Starting Distance of 4 Meters Baseline, and the average of Week 36 and Week 40 | Intravitreal Arm | 0.5 letters |
| PDS Implant Arm | 0.2 letters | |||
| NCT03805100 XPLORE | Macular Degeneration | Change in Best Corrected Visual Acuity (BCVA) Baseline and Week 8 | Lucentis (Ranibizumab) | 6.37 Letters |
| Xlucane (Proposed Ranibizumab Biosimilar) | 4.57 Letters | |||
| NCT04503551 PAVILION | Diabetic Retinopathy | Percentage of Participants With a ≥2-Step Improvement From Baseline on the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale (ETDRS-DRSS) at Week 52 Baseline, Week 52 | Comparator Arm | 9.0 percentage of participants |
| PDS With Ranibizumab 100 mg/mL | 80.1 percentage of participants | |||
| NCT04690556 | — | Mean Change in BCVA From Baseline in the Study Eye at the End of 12 Months Baseline and 12 Months | LUBT010 (Proposed Ranibizumab Biosimilar) | 11.17 Letters (±0.689 Standard Error) |
| Lucentis (Ranibizumab) | 11.14 Letters (±0.680 Standard Error) | |||
| NCT04757610 ShORe | — | Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters Baseline to Week 52 | 0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302 | 12.41 Letters read (±0.731 Standard Error) |
| 0.5 mg Ranibizumab With Sham | 14.30 Letters read (±0.719 Standard Error) | |||
| 0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302 | 13.20 Letters read (±0.728 Standard Error) |