drugset / Trial / NCT05151744

A Study to Investigate Vamikibart (RO7200220) in Combination With Ranibizumab in Diabetic Macular Edema

NCT05151744

Phase 2 Completed 187 enrolled Hoffmann-La Roche
RandomizedParallel-groupTriple-blindTreatment

Summary

Study BP43464 is a phase II, multicenter, randomized, double-masked active comparator-controlled study designed to assess the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of vamikibart in combination with, anti-vascular endothelial growth factor (VEGF) inhibitor, ranibizumab compared with ranibizumab alone in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be 76 weeks.

Timeline

Start
2021-12-17
Primary completion
2024-04-17
Completion
2024-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ranibizumab Monoclonal antibody 0.5 mg Intravitreal
Subject Vamikibart Monoclonal antibody 1 mg Intravitreal