MedTrace Logo

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

NCT05151744 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2025-10-16

Study results available
· View outcomes & findings →

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-17
Primary Completion
2024-04-17
Completion
2024-10-01
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Canada
  • Israel
  • Poland
  • Puerto Rico
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05151744 on ClinicalTrials.gov