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

NCT05151731 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 394

Last updated 2026-05-11

Study results available
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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

Interventions

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.

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
2021-12-31
Primary Completion
2024-11-06
Completion
2025-04-21
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Canada
  • Czechia
  • 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 NCT05151731 on ClinicalTrials.gov