A Study to Investigate Vamikibart (RO7200220) in Diabetic Macular Edema
Summary
Study BP43445 is a phase II, multicenter, randomized, double-masked, active comparator-controlled study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of vamikibart administered intravitreally in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be up to 76 weeks.
Timeline
- Start
- 2021-12-31
- Primary completion
- 2024-11-06
- Completion
- 2025-04-21
Outcome
Missed primary endpoint
registry analysis (superiority test); Arm A: Vamikibart 0.25 mg Q8W vs Arm D: Ranibizumab 0.5 mg Q4W; p = 0.0012; Difference in Adjusted Means -5.9 NCT05151731 ↗
registry analysis (superiority test); Arm B: Vamikibart 1 mg Q8W vs Arm D: Ranibizumab 0.5 mg Q4W; p <0.0001; Difference in Adjusted Means -8.4 NCT05151731 ↗
registry analysis (superiority test); Arm C: Vamikibart 1 mg Q4W vs Arm D: Ranibizumab 0.5 mg Q4W; p <0.0001; Difference in Adjusted Means -7.5 NCT05151731 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ranibizumab | Monoclonal antibody | 0.5 mg | Intravitreal |
| Subject | Vamikibart | Monoclonal antibody | 0.25 mg | Intravitreal |
| Subject | Vamikibart | Monoclonal antibody | 1 mg | Intravitreal |