At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Multicenter, Randomized, Double Masked, Active Comparator-Controlled Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7200220 Administered Intravitreally in Patients With Diabetic Macular Edema
In Brief
A Phase 2 clinical trial evaluating Vamikibart, Ranibizumab, and 1 other intervention for Diabetic Macular Edema. Completed, enrolled 394 participants across 74 sites in 9 countries.
Detailed 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.
Study Details
Timeline
Interventions
Vamikibart will be administered by IVT injection as specified in each treatment arm.
Ranibizumab 0.5 mg will be administered to the participants by IVT injection, as specified in the treatment arm.
Sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. Sham procedure will be administered to participants in the Q8W arms at applicable visits to maintain masking between treatment arms.