NCT05151744

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 187 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Vamikibart	Vamikibart will be administered by IVT injection in the study eye.
DRUG	Ranibizumab	Ranibizumab will be administered by IVT injection in the study eye.
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.

Timeline

• Start date: 2021-12-17
• Primary completion: 2024-04-17
• Completion: 2024-10-01
• First posted: 2021-12-09
• Last updated: 2025-10-16
• Results posted: 2025-10-16

Locations

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

Regulatory

• FDA-regulated drug study