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COMPLETED
NCT05151731
PHASE2

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

394

Start Date

2021-12-31

Completion Date

2025-04-21

Last Updated

2026-05-11

Healthy Volunteers

No

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.

Locations (74)

Win Retina

Arcadia, California, United States

Retina Consultants, San Diego

Poway, California, United States

Retinal Consultants Med Group

Sacramento, California, United States

Bay Area Retina Associates

Walnut Creek, California, United States

Colorado Retina Associates, PC

Lakewood, Colorado, United States

Emerson Clinical Research Institute LLC

Washington D.C., District of Columbia, United States

Rand Eye

Deerfield Beach, Florida, United States

National Ophthalmic Research Institute

Fort Myers, Florida, United States

Florida Retina Institute

Orlando, Florida, United States

Retina Vitreous Associates of Florida

St. Petersburg, Florida, United States

Retina Specialists of Tampa

Wesley Chapel, Florida, United States

Butchertown Clinical Trials

Louisville, Kentucky, United States

Cumberland Valley Retina PC

Hagerstown, Maryland, United States

Deep Blue Retina PLLC

Southaven, Mississippi, United States

Sierra Eye Associates

Reno, Nevada, United States

Opthalmic Consultants of LI

Lynbrook, New York, United States

University of Rochester Flaum Eye Institute

Rochester, New York, United States

Western Carolina Retinal Associate PA

Asheville, North Carolina, United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Meridian Clinical Research

Cincinnati, Ohio, United States

Verum Research LLC

Eugene, Oregon, United States

EyeHealth Northwest

Portland, Oregon, United States

Erie Retinal Surgery

Erie, Pennsylvania, United States

Eye Care Specialists, PC

Kingston, Pennsylvania, United States

Sewickley Eye Group

Sewickley, Pennsylvania, United States

Charleston Neuroscience Institute

Ladson, South Carolina, United States

Black Hills Eye Institute

Rapid City, South Dakota, United States

Retina Consultants of Nashville

Nashville, Tennessee, United States

Texas Retina Associates

Arlington, Texas, United States

Austin Clinical Research LLC

Austin, Texas, United States

Retina Consultants of Texas

Bellaire, Texas, United States

Valley Retina Institute P.A.

McAllen, Texas, United States

Retina Consultants of Texas

The Woodlands, Texas, United States

Strategic Clinical Research Group, LLC

Willow Park, Texas, United States

Piedmont Eye Center

Lynchburg, Virginia, United States

Wagner Macula & Retina Center

Norfolk, Virginia, United States

Organizacion Medica de Investigacion

Buenos Aires, Argentina

Centro Oftalmologico Dr. Charles S.A.

Capital Federal, Argentina

Oftalmos

Capital Federal, Argentina

Buenos Aires Mácula

Ciudad Autonoma Buenos Aires, Argentina

Centro Privado de Ojos Romagosa

Córdoba, Argentina

Centro de ojos Loria

Lomas de Zamora, Argentina

Oftar

Mendoza, Argentina

Microcirugía Ocular S.A

Rosario, Argentina

Grupo Laser Vision

Rosario, Argentina

Retina Institute of Ottawa

Ottawa, Ontario, Canada

Toronto Retina Institute

Toronto, Ontario, Canada

Institut De L'Oeil Des Laurentides

Boisbriand, Quebec, Canada

Faculty Hospital Ostrava

Ostrava, Czechia

Faculty Hospital Kralovske Vinohrady

Prague, Czechia

General Teaching Hospital Prague

Prague, Czechia

AXON Clinical

Prague, Czechia

Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA

Gliwice, Poland

Uniwersyteckie Centrum Kliniczne

Katowice, Poland

Centrum Medyczne UNO-MED

Krakow, Poland

SPSK nr 1 w Lublinie

Lublin, Poland

Centrum Diagnostyki i Mikrochirurgii Oka LENS

Olsztyn, Poland

LensClinic

Rybnik, Poland

Caminomed

Tarnowskie Góry, Poland

Emanuelli Research and Development Center LLC

Arecibo, Puerto Rico

Yeungnam University Medical Center

Daegu, South Korea

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Kim's Eye Hospital

Seoul, South Korea

Hospital General de Catalunya

Sant Cugat de Valles, Barcelona, Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Oftalvist Valencia

Burjassot, Valencia, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

Bristol Eye Hospital

Bristol, United Kingdom

Gloucestershire Hospitals NHS Foundation Trust

Gloucestershire, United Kingdom

Royal Surrey County Hospital

Guildford, United Kingdom

Moorfields Eye Hospital NHS Foundation Trust

London, United Kingdom

Royal Victoria Infirmary

Newcastle upon Tyne, United Kingdom