NCT05151731

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 394 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Vamikibart	Vamikibart will be administered by IVT injection as specified in each treatment arm.
DRUG	Ranibizumab	Ranibizumab 0.5 mg will be administered to the participants by IVT injection, as specified in the treatment arm.
OTHER	Sham Procedure	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.

Timeline

• Start date: 2021-12-31
• Primary completion: 2024-11-06
• Completion: 2025-04-21
• First posted: 2021-12-09
• Last updated: 2025-10-22

Locations

74 sites across 9 countries: United States, Argentina, Canada, Czechia, Poland, Puerto Rico, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study