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A Study to Investigate Vamikibart (RO7200220) in Diabetic Macular Edema
Sponsor: Hoffmann-La Roche
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
Conditions
Interventions
Vamikibart
Vamikibart will be administered by IVT injection as specified in each treatment arm.
Ranibizumab
Ranibizumab 0.5 mg will be administered to the participants by IVT injection, as specified in the treatment arm.
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