Phase
Condition
Diabetic Retinopathy
Retina
Treatment
Vitrectomy
Faricimab
Panretinal Photocoagulation (PRP)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Individual:
≥ 18 years old
Diagnosis of diabetes mellitus (type 1 or type 2)
Study Eye:(A participant can have one or two study eyes if both eyes are eligible at screening.)
Presence of PDR requiring treatment, defined as moderate PDR or worse on globalgrading of ultrawide field fundus photos or NV meeting criteria for moderate PDR orworse on global grading of ultrawide field FA, confirmed by a central reading center
Best corrected visual acuity ≥49 letters (20/100 Snellen equivalent or better)
Exclusion
Exclusion Criteria:
Individual:
Significant renal disease, defined as a history of chronic renal failurerequiring dialysis or kidney transplant.
Blood pressure > 160/100 (systolic above 160 or diastolic above 100).o If blood pressure is brought below 160/100 by anti-hypertensive treatment,individual can become eligible.
For women of child-bearing potential: pregnant or lactating or intending tobecome pregnant within the next 3 years.
Women of childbearing potential will be required to have pregnancy testingor use an acceptable method of pregnancy prevention. Women who arepotential study participants should be questioned about the potential forpregnancy at baseline and prior to each injection. Pregnancy test isrequired for all women of childbearing potential at baseline. Investigatorjudgment is used to determine when a pregnancy test is needed duringfollow up.
Study Eye: (A participant can have two study eyes.)
Traction retinal detachment involving the macula
Significant vitreous hemorrhage that would preclude completion of a full PRP
Significant vitreomacular traction
Any prior vitrectomy
Any prior PRP (defined as ≥100 burns outside of the posterior pole)
Treatment for DME within the prior 6 months
Intravitreal anti-VEGF for any indication, other than DME, within the prior year
Study Design
Study Description
Connect with a study center
Retina Associates of Southern California
Huntington Beach 5358705, California 5332921 92647
United StatesActive - Recruiting
Loma Linda University
Loma Linda 5367696, California 5332921 92354
United StatesActive - Recruiting
Florida Retina Consultants
Lakeland 4161438, Florida 4155751 33805
United StatesActive - Recruiting
Ophthalmic Partners of Florida, PA dba Central Florida Retina
Orlando 4167147, Florida 4155751 32806
United StatesActive - Recruiting
Retina Associates of Florida, LLC
Tampa 4174757, Florida 4155751 33609
United StatesActive - Recruiting
Southeast Retina Center, P.C.
Augusta 4180531, Georgia 4197000 30909
United StatesActive - Recruiting
Illinois Retina Associates SC Oak Park Site
Oak Park 4904381, Illinois 4896861 60304
United StatesActive - Recruiting
Midwest Eye Institute
Carmel 4255466, Indiana 4921868 46032
United StatesActive - Recruiting
Wolfe Clinic, P.C.- West Des Moines
West Des Moines 4881346, Iowa 4862182 50266
United StatesActive - Recruiting
Mid-America Retina Consultants, P.A.
Overland, Kansas 4273857 66211
United StatesActive - Recruiting
University of Kentucky Advanced Eye Care
Lexington 4297983, Kentucky 6254925 40508
United StatesActive - Recruiting
Elman Retina Group, P.A.
Baltimore 4347778, Maryland 4361885 21237
United StatesActive - Recruiting
Boston Medical Center Corporation
Boston 4930956, Massachusetts 6254926 02118
United StatesActive - Recruiting
Joslin Diabetes Center
Boston 4930956, Massachusetts 6254926 02215
United StatesActive - Recruiting
Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905
United StatesActive - Recruiting
Retina Research Institute, LLC
St Louis 4407066, Missouri 4398678 63128
United StatesActive - Recruiting
Retina Associates of Western NY, P.C.
Rochester 5134086, New York 5128638 14620
United StatesActive - Recruiting
Retina-Vitreous Consultants, Inc.
Monroeville 5201734, Pennsylvania 6254927 15146
United StatesActive - Recruiting
Retina Consultants of Texas, PA
Bellaire 4673353, Texas 4736286 77401
United StatesActive - Recruiting
Texas Retina Associates
Lubbock 5525577, Texas 4736286 79424
United StatesActive - Recruiting

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