CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 187 enrolled
Drug / intervention
Vamikibart +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05151744
NCT05151744Phase 2Completed

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

Hoffmann-La Roche·interventional·Posted Dec 9, 2021·Updated Oct 16, 2025

In Brief

A Phase 2 clinical trial evaluating Vamikibart, Ranibizumab, and 1 other intervention for Diabetic Macular Edema. Completed, enrolled 187 participants across 38 sites in 9 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Canada, Israel, Poland, Puerto Rico, South Korea, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedDec 9, 2021
Enrollment StartDec 17, 2021
Primary CompletionApr 17, 2024
Study CompletionOct 1, 2024
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 4.6 years ago

Interventions

Vamikibartdrug

Vamikibart will be administered by IVT injection in the study eye.

Ranibizumabdrug

Ranibizumab will be administered by IVT injection in the study eye.

Sham Procedureother

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.