Phase
Condition
Diabetic Macular Edema
Diabetic Retinopathy
Macular Edema
Treatment
Faricimab
RO7446603
Aflibercept
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Documented diagnosis of diabetes mellitus (DM) (Type 1 or Type 2) with glycatedhemoglobin (HbA1c) < 12%
Macular thickening secondary to DME involving the center of the fovea > 325 microns
Decreased VA attributable primarily to DME between 25 and 73 ETDRS letters
Exclusion
Exclusion Criteria:
Currently untreated DM or previously untreated participants who initiated oralanti-diabetic medication or insulin within 90 days prior to Day 1
Uncontrolled blood pressure (BP)
Pregnancy or breastfeeding, or intention to become pregnant during the study
For Parts 1-4: IVT anti-VEGF treatment within 90 days prior to Day 1; For Part 5:IVT anti-VEGF treatment within 120 days prior to Day 1 or IVT anti-VEGF treatmentprior to Day 1 for treatment naïve participants
Treatment with SUSVIMOTM (ranibizumab injection) prior to Day 1
Any IVT or periocular (sub-tenons) corticosteroid treatment within 6 months prior toDay 1
Any current or history of ocular disease other than DME that may confound assessmentof the macula or affect central vision
Proliferative diabetic retinopathy (PDR) in the study eye
Active or history of uveitis, vitritis (grade trace or above), and/or scleritis ineither eye Other protocol-specified inclusion/exclusion criteria may apply
Study Design
Connect with a study center
Shanghai General Hospital - North Campus
Shanghai, 200080
ChinaActive - Recruiting
Emanuelli Research and Development Center LLC
Arecibo, 00612
Puerto RicoActive - Recruiting
Arizona Retina and Vitreous Consultants
Phoenix, Arizona 85020-5917
United StatesActive - Recruiting
Associated Retinal Consultants PC
Phoenix, Arizona 85020
United StatesActive - Recruiting
Barnet Dulaney Perkins Eye Center
Phoenix, Arizona 85016
United StatesSite Not Available
Retinal Consultants of Arizona
Phoenix, Arizona 85053
United StatesActive - Recruiting
Retinal Research Institute, LLC
Phoenix, Arizona 85053
United StatesActive - Recruiting
Retinal Diagnostic Center
Campbell, California 95008
United StatesActive - Recruiting
The Retina Partners
Encino, California 91436
United StatesSite Not Available
Retina Consultants of Orange County
Fullerton, California 92835
United StatesActive - Recruiting
Retinal Consultants Medical Group
Modesto, California 95356-9412
United StatesActive - Recruiting
Northern California Retina-Vitreous Associates
Mountain View, California 94040
United StatesActive - Recruiting
Retinal Consultants Medical Group
Sacramento, California 95825
United StatesActive - Recruiting
Macula Retina Vitreous Research Institute
Torrance, California 90503-3270
United StatesActive - Recruiting
Retina Specialists of Colorado
Aurora, Colorado 80012
United StatesSite Not Available
Retina Consultants of Southern Colorado PC
Colorado Springs, Colorado 80909
United StatesActive - Recruiting
Retina Specialists of Colorado
Denver, Colorado 80222
United StatesActive - Recruiting
Advanced Vision Research Institute
Longmont, Colorado 80503-6499
United StatesActive - Recruiting
Retina Group of New England
Waterford, Connecticut 06385-1215
United StatesActive - Recruiting
Blue Ocean Clinical Research
Clearwater, Florida 33761-2046
United StatesActive - Recruiting
National Ophthalmic Research Institute
Fort Myers, Florida 33912
United StatesActive - Recruiting
Florida Retina Institute
Jacksonville, Florida 32216-6347
United StatesActive - Recruiting
Retina Associates of Florida;Retina Associates of Florida
Tampa, Florida 33609
United StatesActive - Recruiting
Southeast Retina Center
Augusta, Georgia 30909-6440
United StatesActive - Recruiting
Georgia Retina PC
Marietta, Georgia 30060
United StatesActive - Recruiting
University Retina and Macula Associates, PC
Lemont, Illinois 60439
United StatesActive - Recruiting
Raj K. Maturi, MD PC
Indianapolis, Indiana 46290
United StatesCompleted
Johns Hopkins Hospital
Baltimore, Maryland 21287
United StatesActive - Recruiting
The Retina Care Center
Baltimore, Maryland 21209
United StatesActive - Recruiting
Retina Group of Washington
Chevy Chase, Maryland 20815
United StatesActive - Recruiting
Cumberland Valley Retina Consultants
Hagerstown, Maryland 21740
United StatesActive - Recruiting
Long Island Vitreoretinal Consultants;Opthalmology
Hauppauge, New York 11788
United StatesActive - Recruiting
Retina Vitreous Surgeons of CNY PC
Liverpool, New York 13088
United StatesActive - Recruiting
Western Carolina Retinal Associate PA
Asheville, North Carolina 28803
United StatesActive - Recruiting
Duke University Medical Center
Durham, North Carolina 27705
United StatesActive - Recruiting
Graystone Eye
Hickory, North Carolina 28602
United StatesActive - Recruiting
Piedmont Retina Specialists
Winston-Salem, North Carolina 27103-6970
United StatesActive - Recruiting
Cincinnati Eye Institute
Blue Ash, Ohio 45242-5537
United StatesActive - Recruiting
Ohio State Eye and Ear Institute
Columbus, Ohio 43212
United StatesActive - Recruiting
Tulsa Retina Consultants
Tulsa, Oklahoma 74114
United StatesActive - Recruiting
Cascade Medical Research Institute LLC
Springfield, Oregon 97477
United StatesActive - Recruiting
Erie Retina Research
Erie, Pennsylvania 16507-1429
United StatesActive - Recruiting
Sewickely Eye Group
Sewickley, Pennsylvania 15143
United StatesActive - Recruiting
Palmetto Retina Center
West Columbia, South Carolina 29169-2429
United StatesActive - Recruiting
Charles Retina Institute
Germantown, Tennessee 38138
United StatesActive - Recruiting
Retina Research Institute of Texas
Abilene, Texas 79606
United StatesActive - Recruiting
Texas Retina Associates
Arlington, Texas 76012
United StatesActive - Recruiting
Austin Clinical Research LLC
Austin, Texas 78750
United StatesActive - Recruiting
Austin Retina Associates
Austin, Texas 78705
United StatesActive - Recruiting
Retina & Vitreous of Texas
Bellaire, Texas 77401
United StatesActive - Recruiting
Texas Retina Associates
Dallas, Texas 75231
United StatesActive - Recruiting
Valley Retina Institute P.A.
McAllen, Texas 78550-9207
United StatesActive - Recruiting
Brown Retina Institute
San Antonio, Texas 78251-4551
United StatesActive - Recruiting
Medical Center Ophthalmology Associates
San Antonio, Texas 78240
United StatesActive - Recruiting
Retina Consultants of Texas - San Antonio
San Antonio, Texas 78240
United StatesActive - Recruiting
Retina Consultants of Texas
The Woodlands, Texas 77384
United StatesActive - Recruiting
Strategic Clinical Research Group, LLC
Willow Park, Texas 76087
United StatesActive - Recruiting
Retina Associates of Utah, PLLC;Clinical Research
Salt Lake City, Utah 84107
United StatesActive - Recruiting
Piedmont Eye Center
Lynchburg, Virginia 24502-4271
United StatesActive - Recruiting
Wagner Kapoor Institute
Norfolk, Virginia 23502
United StatesActive - Recruiting
Retina Institute of Virginia
Richmond, Virginia 23235-1962
United StatesActive - Recruiting
Spokane Eye Clinical Research
Spokane, Washington 99204
United StatesActive - Recruiting
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