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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7446603 Administered Alone or in Combination With Aflibercept or Faricimab in Participants With Diabetic Macular Edema
Sponsor: Genentech, Inc.
Summary
This study aims to evaluate the ocular and systemic safety, tolerability and efficacy of RO7446603 in participants with diabetic macular edema (DME). The study consists of 2 segments: Phase I (Parts 1-4) and Phase II (Part 5). Phase I investigated the safety of RO7446603 following a single and multiple intravitreal (IVT) doses as monotherapy or co-administered with IVT aflibercept or IVT faricimab (in separate injections). Phase II will investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of two dose levels of RO7446603 in combination with faricimab, with the two drugs co-mixed and administered as a single IVT injection, compared to faricimab alone. The first participant was enrolled in the Phase I segment on June 22, 2022. Phase I has been completed.
Official title: A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7446603 Administered Alone or in Combination With Aflibercept or Faricimab in Patients With Diabetic Macular Edema
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
546
Start Date
2022-06-22
Completion Date
2027-04-30
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
RO7446603
Participants will receive RO7446603 as an IVT injection per the schedule described in the treatment arms.
Aflibercept
Participants will receive aflibercept as an IVT injection per the schedule described in the treatment arm.
Faricimab
Participants will receive faricimab as an IVT injection per the schedule described in the treatment arms.
Locations (78)
Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, United States
Arizona Retina and Vitreous Consultants
Phoenix, Arizona, United States
Associated Retinal Consultants PC
Phoenix, Arizona, United States
Retinal Research Institute, LLC
Phoenix, Arizona, United States
Retinal Diagnostic Center
Campbell, California, United States
The Retina Partners
Encino, California, United States
Retina Consultants of Orange County
Fullerton, California, United States
Retinal Consultants Medical Group
Modesto, California, United States
Northern California Retina-Vitreous Associates
Mountain View, California, United States
Retinal Consultants Medical Group
Sacramento, California, United States
University of California San Francisco
San Francisco, California, United States
Macula Retina Vitreous Research Institute
Torrance, California, United States
University of Colorado - Eye Center - PPDS
Aurora, Colorado, United States
Retina Consultants of Southern Colorado PC
Colorado Springs, Colorado, United States
Retina Specialists of Colorado
Denver, Colorado, United States
Advanced Vision Research Institute
Longmont, Colorado, United States
Retina Group of New England
Waterford, Connecticut, United States
Blue Ocean Clinical Research
Clearwater, Florida, United States
National Ophthalmic Research Institute
Fort Myers, Florida, United States
Florida Retina Institute
Jacksonville, Florida, United States
Retina Associates of Florida;Retina Associates of Florida
Tampa, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
Georgia Retina PC
Marietta, Georgia, United States
Retina Consultants of Hawaii
‘Aiea, Hawaii, United States
Illinois Eye and Ear Infirmary
Chicago, Illinois, United States
University Retina and Macula Associates, PC
Oak Forest, Illinois, United States
Raj K. Maturi, MD PC
Indianapolis, Indiana, United States
The Retina Care Center
Baltimore, Maryland, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Retina Group of Washington
Chevy Chase, Maryland, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Chesapeake Retina Centers - Waldorf
Waldorf, Maryland, United States
Associated Retinal Consultants - Royal Oak
Royal Oak, Michigan, United States
Retina Consultants Minnesota
Saint Louis Park, Minnesota, United States
Long Island Vitreoretinal Consultants;Opthalmology
Hauppauge, New York, United States
Retina Vitreous Surgeons of CNY PC
Liverpool, New York, United States
Opthalmic Consultants of LI
Lynbrook, New York, United States
Western Carolina Retinal Associate PA
Asheville, North Carolina, United States
North Carolina Retina Associates
Cary, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Graystone Eye
Hickory, North Carolina, United States
North Carolina (NC) Retina Associates - Wake Forest Office
Wake Forest, North Carolina, United States
Piedmont Retina Specialists
Winston-Salem, North Carolina, United States
Cincinnati Eye Institute
Blue Ash, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Ohio State Eye and Ear Institute
Columbus, Ohio, United States
Tulsa Retina Consultants
Tulsa, Oklahoma, United States
Cascade Medical Research Institute LLC
Springfield, Oregon, United States
Erie Retina Research
Erie, Pennsylvania, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Sewickely Eye Group
Sewickley, Pennsylvania, United States
Palmetto Retina Center
West Columbia, South Carolina, United States
Charles Retina Institute
Germantown, Tennessee, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Texas Retina Associates
Arlington, Texas, United States
Austin Retina Associates
Austin, Texas, United States
Austin Clinical Research LLC
Austin, Texas, United States
Retina & Vitreous of Texas
Bellaire, Texas, United States
Texas Retina Associates
Dallas, Texas, United States
Valley Retina Institute P.A.
McAllen, Texas, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
Retina Consultants of Texas - San Antonio
San Antonio, Texas, United States
Brown Retina Institute
San Antonio, Texas, United States
Retina Consultants of Texas
The Woodlands, Texas, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, United States
Retina Associates of Utah, PLLC;Clinical Research
Salt Lake City, Utah, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Wagner Kapoor Institute
Norfolk, Virginia, United States
Virginia Eye Institute - Richmond - 7301 Forest Ave
Richmond, Virginia, United States
Retina Institute of Virginia
Richmond, Virginia, United States
Spokane Eye Clinical Research
Spokane, Washington, United States
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China
Eye Hospital,WMU(Zhejiang Eye Hospital)
Wenzhou, Zhejiang, China
Beijing Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Shanghai General Hospital - North Campus
Shanghai, China
Emanuelli Research and Development Center LLC
Arecibo, Puerto Rico