Phase
Condition
Macular Edema
Diabetic Retinopathy
Diabetic 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
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality 100730
ChinaActive - Recruiting
Beijing Tongren Hospital, Capital Medical University
Beijing 1816670, Beijing Municipality 2038349 100730
ChinaSite Not Available
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality 300384
ChinaActive - Recruiting
Tianjin Medical University Eye Hospital
Tianjin 1792947, Tianjin Municipality 1792943 300384
ChinaSite Not Available
Eye Hospital,WMU(Zhejiang Eye Hospital)
Wenzhou, Zhejiang 325027
ChinaActive - Recruiting
Eye Hospital,WMU(Zhejiang Eye Hospital)
Wenzhou 1791388, Zhejiang 1784764 325027
ChinaSite Not Available
Beijing Hospital
Beijing, 100730
ChinaActive - Recruiting
Peking Union Medical College Hospital
Beijing, 100730
ChinaActive - Recruiting
Beijing Hospital
Beijing 1816670, 100730
ChinaActive - Recruiting
Peking Union Medical College Hospital
Beijing 1816670, 100730
ChinaActive - Recruiting
Shanghai General Hospital - North Campus
Shanghai, 200080
ChinaActive - Recruiting
Shanghai General Hospital - North Campus
Shanghai 1796236, 200080
ChinaSite Not Available
Emanuelli Research and Development Center LLC
Arecibo, 00612
Puerto RicoActive - Recruiting
Emanuelli Research and Development Center LLC
Arecibo 4562635, 00612
Puerto RicoSite Not Available
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
Arizona Retina and Vitreous Consultants
Phoenix 5308655, Arizona 5551752 85020-5917
United StatesActive - Recruiting
Associated Retinal Consultants PC
Phoenix 5308655, Arizona 5551752 85020
United StatesSite Not Available
Barnet Dulaney Perkins Eye Center
Phoenix 5308655, Arizona 5551752 85016
United StatesSite Not Available
Retinal Research Institute, LLC
Phoenix 5308655, Arizona 5551752 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
University of California San Francisco
San Francisco, California 94158
United StatesActive - Recruiting
Macula Retina Vitreous Research Institute
Torrance, California 90503-3270
United StatesActive - Recruiting
Bay Area Retina Associates;Study Department
Walnut Creek, California 94598
United StatesSite Not Available
Retinal Diagnostic Center
Campbell 5333689, California 5332921 95008
United StatesSite Not Available
The Retina Partners
Encino 5346649, California 5332921 91436
United StatesSite Not Available
Retina Consultants of Orange County
Fullerton 5351247, California 5332921 92835
United StatesSite Not Available
Retinal Consultants Medical Group
Modesto 5373900, California 5332921 95356-9412
United StatesSite Not Available
Northern California Retina-Vitreous Associates
Mountain View 5375480, California 5332921 94040
United StatesSite Not Available
Retinal Consultants Medical Group
Sacramento 5389489, California 5332921 95825
United StatesSite Not Available
University of California San Francisco
San Francisco 5391959, California 5332921 94158
United StatesSite Not Available
Macula Retina Vitreous Research Institute
Torrance 5403022, California 5332921 90503-3270
United StatesSite Not Available
Bay Area Retina Associates;Study Department
Walnut Creek 5406990, California 5332921 94598
United StatesSite Not Available
Retina Specialists of Colorado
Aurora, Colorado 80012
United StatesSite Not Available
University of Colorado - Eye Center - PPDS
Aurora, Colorado 80045-2517
United StatesActive - Recruiting
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
University of Colorado - Eye Center - PPDS
Aurora 5412347, Colorado 5417618 80045-2517
United StatesSite Not Available
Retina Consultants of Southern Colorado PC
Colorado Springs 5417598, Colorado 5417618 80909
United StatesSite Not Available
Retina Specialists of Colorado
Denver 5419384, Colorado 5417618 80222
United StatesSite Not Available
Advanced Vision Research Institute
Longmont 5579276, Colorado 5417618 80503-6499
United StatesSite Not Available
Retina Group of New England
Waterford, Connecticut 06385-1215
United StatesActive - Recruiting
Retina Group of New England
Waterford 8480031, Connecticut 4831725 06385-1215
United StatesSite Not Available
Blue Ocean Clinical Research
Clearwater, Florida 33761-2046
United StatesSite Not Available
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
Blue Ocean Clinical Research
Clearwater 4151316, Florida 4155751 33761-2046
United StatesSite Not Available
National Ophthalmic Research Institute
Fort Myers 4155995, Florida 4155751 33912
United StatesSite Not Available
Florida Retina Institute
Jacksonville 4160021, Florida 4155751 32216-6347
United StatesSite Not Available
Retina Associates of Florida;Retina Associates of Florida
Tampa 4174757, Florida 4155751 33609
United StatesSite Not Available
Southeast Retina Center
Augusta, Georgia 30909-6440
United StatesActive - Recruiting
Georgia Retina PC
Marietta, Georgia 30060
United StatesActive - Recruiting
Southeast Retina Center
Augusta 4180531, Georgia 4197000 30909-6440
United StatesSite Not Available
Georgia Retina PC
Marietta 4207783, Georgia 4197000 30060
United StatesSite Not Available
Retina Consultants of Hawaii
'Aiea, Hawaii 96701
United StatesSite Not Available
Retina Consultants of Hawaii
‘Aiea, Hawaii 96701
United StatesActive - Recruiting
Retina Consultants of Hawaii
‘Aiea 5856430, Hawaii 5855797 96701
United StatesSite Not Available
Illinois Eye and Ear Infirmary
Chicago, Illinois 60612
United StatesActive - Recruiting
University Retina and Macula Associates, PC
Lemont, Illinois 60439
United StatesSite Not Available
University Retina and Macula Associates, PC
Oak Forest, Illinois 60452
United StatesActive - Recruiting
Illinois Eye and Ear Infirmary
Chicago 4887398, Illinois 4896861 60612
United StatesSite Not Available
University Retina and Macula Associates, PC
Oak Forest 4904286, Illinois 4896861 60452
United StatesSite Not Available
Raj K. Maturi, MD PC
Indianapolis, Indiana 46290
United StatesCompleted
Raj K. Maturi, MD PC
Indianapolis 4259418, Indiana 4921868 46290
United StatesSite Not Available
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
Chesapeake Retina Centers - Waldorf
Waldorf, Maryland 20602
United StatesActive - Recruiting
Johns Hopkins Hospital
Baltimore 4347778, Maryland 4361885 21287
United StatesActive - Recruiting
The Retina Care Center
Baltimore 4347778, Maryland 4361885 21209
United StatesSite Not Available
Retina Group of Washington
Chevy Chase 4351335, Maryland 4361885 20815
United StatesSite Not Available
Cumberland Valley Retina Consultants
Hagerstown 4357141, Maryland 4361885 21740
United StatesSite Not Available
Chesapeake Retina Centers - Waldorf
Waldorf 4372599, Maryland 4361885 20602
United StatesSite Not Available
Associated Retinal Consultants - Royal Oak
Royal Oak, Michigan 48073
United StatesActive - Recruiting
Associated Retinal Consultants - Royal Oak
Royal Oak 5007804, Michigan 5001836 48073
United StatesSite Not Available
Retina Consultants Minnesota
Saint Louis Park, Minnesota 55416
United StatesActive - Recruiting
Retina Consultants Minnesota
Saint Louis Park 5045021, Minnesota 5037779 55416
United StatesSite Not Available
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
Opthalmic Consultants of LI
Lynbrook, New York 11563
United StatesActive - Recruiting
Long Island Vitreoretinal Consultants;Opthalmology
Hauppauge 5120228, New York 5128638 11788
United StatesSite Not Available
Retina Vitreous Surgeons of CNY PC
Liverpool 5124925, New York 5128638 13088
United StatesSite Not Available
Opthalmic Consultants of LI
Lynbrook 5125523, New York 5128638 11563
United StatesSite Not Available
Western Carolina Retinal Associate PA
Asheville, North Carolina 28803
United StatesActive - Recruiting
North Carolina Retina Associates
Cary, North Carolina 27511
United StatesActive - Recruiting
Duke University Medical Center
Durham, North Carolina 27705
United StatesActive - Recruiting
Graystone Eye
Hickory, North Carolina 28602
United StatesActive - Recruiting
North Carolina (NC) Retina Associates - Wake Forest Office
Wake Forest, North Carolina 27587-3803
United StatesActive - Recruiting
Piedmont Retina Specialists
Winston-Salem, North Carolina 27103-6970
United StatesActive - Recruiting
Western Carolina Retinal Associate PA
Asheville 4453066, North Carolina 4482348 28803
United StatesSite Not Available
North Carolina Retina Associates
Cary 4459467, North Carolina 4482348 27511
United StatesSite Not Available
Duke University Medical Center
Durham 4464368, North Carolina 4482348 27705
United StatesSite Not Available
Graystone Eye
Hickory 4470778, North Carolina 4482348 28602
United StatesSite Not Available
North Carolina (NC) Retina Associates - Wake Forest Office
Wake Forest 4497290, North Carolina 4482348 27587-3803
United StatesSite Not Available
Piedmont Retina Specialists
Winston-Salem 4499612, North Carolina 4482348 27103-6970
United StatesSite Not Available
Cincinnati Eye Institute
Blue Ash, Ohio 45242-5537
United StatesActive - Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44016
United StatesActive - Recruiting
Ohio State Eye and Ear Institute
Columbus, Ohio 43212
United StatesActive - Recruiting
Cincinnati Eye Institute
Blue Ash 4506754, Ohio 5165418 45242-5537
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44016
United StatesSite Not Available
Ohio State Eye and Ear Institute
Columbus 4509177, Ohio 5165418 43212
United StatesSite Not Available
Tulsa Retina Consultants
Tulsa, Oklahoma 74114
United StatesActive - Recruiting
Tulsa Retina Consultants
Tulsa 4553433, Oklahoma 4544379 74114
United StatesSite Not Available
Cascade Medical Research Institute LLC
Springfield, Oregon 97477
United StatesActive - Recruiting
Cascade Medical Research Institute LLC
Springfield 5754005, Oregon 5744337 97477
United StatesSite Not Available
Erie Retina Research
Erie, Pennsylvania 16505
United StatesActive - Recruiting
Wills Eye Hospital
Philadelphia, Pennsylvania 19107-5109
United StatesActive - Recruiting
Sewickely Eye Group
Sewickley, Pennsylvania 15143
United StatesActive - Recruiting
Erie Retina Research
Erie 5188843, Pennsylvania 6254927 16505
United StatesSite Not Available
Wills Eye Hospital
Philadelphia 4560349, Pennsylvania 6254927 19107-5109
United StatesSite Not Available
Sewickely Eye Group
Sewickley 5211506, Pennsylvania 6254927 15143
United StatesSite Not Available
Palmetto Retina Center
West Columbia, South Carolina 29169-2429
United StatesActive - Recruiting
Palmetto Retina Center
West Columbia 4600541, South Carolina 4597040 29169-2429
United StatesSite Not Available
Charles Retina Institute
Germantown, Tennessee 38138
United StatesActive - Recruiting
Charles Retina Institute
Germantown 4624601, Tennessee 4662168 38138
United StatesSite Not Available
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 Research Institute of Texas
Abilene 4669635, Texas 4736286 79606
United StatesSite Not Available
Texas Retina Associates
Arlington 4671240, Texas 4736286 76012
United StatesSite Not Available
Austin Clinical Research LLC
Austin 4671654, Texas 4736286 78750
United StatesSite Not Available
Austin Retina Associates
Austin 4671654, Texas 4736286 78705
United StatesActive - Recruiting
Retina & Vitreous of Texas
Bellaire 4673353, Texas 4736286 77401
United StatesSite Not Available
Texas Retina Associates
Dallas 4684888, Texas 4736286 75231
United StatesSite Not Available
Valley Retina Institute P.A.
McAllen 4709796, Texas 4736286 78550-9207
United StatesSite Not Available
Brown Retina Institute
San Antonio 4726206, Texas 4736286 78251-4551
United StatesSite Not Available
Medical Center Ophthalmology Associates
San Antonio 4726206, Texas 4736286 78240
United StatesActive - Recruiting
Retina Consultants of Texas - San Antonio
San Antonio 4726206, Texas 4736286 78240
United StatesActive - Recruiting
Retina Consultants of Texas
The Woodlands 4736476, Texas 4736286 77384
United StatesSite Not Available
Strategic Clinical Research Group, LLC
Willow Park 4742296, Texas 4736286 76087
United StatesSite Not Available
Retina Associates of Utah, PLLC;Clinical Research
Salt Lake City, Utah 84107
United StatesActive - Recruiting
Retina Associates of Utah, PLLC;Clinical Research
Salt Lake City 5780993, Utah 5549030 84107
United StatesSite Not Available
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
Virginia Eye Institute - Richmond - 7301 Forest Ave
Richmond, Virginia 23230
United StatesActive - Recruiting
Piedmont Eye Center
Lynchburg 4771075, Virginia 6254928 24502-4271
United StatesSite Not Available
Wagner Kapoor Institute
Norfolk 4776222, Virginia 6254928 23502
United StatesSite Not Available
Retina Institute of Virginia
Richmond 4781708, Virginia 6254928 23235-1962
United StatesActive - Recruiting
Virginia Eye Institute - Richmond - 7301 Forest Ave
Richmond 4781708, Virginia 6254928 23230
United StatesSite Not Available
Spokane Eye Clinical Research
Spokane, Washington 99204
United StatesActive - Recruiting
Spokane Eye Clinical Research
Spokane 5811696, Washington 5815135 99204
United StatesSite Not Available

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