Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of PDR
Start Date
8/4/2025
Completion Date
8/1/2031
Summary
This randomized trial will compare treatment strategies for proliferative diabetic retinopathy (PDR). Participants will receive either combination a of faricimab + PRP or vitrectomy + endolaser. The participants will be followed for 3 years. The study will evaluate long-term visual acuity as well as differences in number of injections, procedures, and complications during follow-up (after completion of randomization treatment), and cost.
Detailed Description
Although some combination of anti-VEGF plus PRP is the most common treatment approach for PDR with and without DME, there are currently no long-term data on a standardized approach. Vitrectomy is not currently used as first-line treatment for early PDR but advances in surgical technique have reduced associated complications and the ability to remove the posterior hyaloid during surgery may have advantages over nonsurgical approaches, especially in the reduction of vitreous hemorrhage and/or traction retinal detachment that may occur later when the hyaloid separates naturally. Protocol S demonstrated both PRP and anti-VEGF alone result in good visual acuity results long-term so it is expected that a combination treatment would also result in good visual acuity results. This study will evaluate the safety and efficacy of two treatment strategies for PDR: faricimab plus PRP and Vitrectomy with endolaser with the goal to determine whether either approach decreases visit and treatment burden along with decreasing complications compared with the other treatment method while maintaining good visual acuity. The primary objectives of this study are to compare visual acuity at 3 years following vitrectomy with endolaser or faricimab+PRP and to compare number of treatments for PDR (i.e., injections, PRP, vitrectomy) following the end of randomized treatment over 3 years.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Vitrectomy
Endolaser
Faricimab
Panretinal Photocoagulation (PRP)
Conditions
Locations
Retina Associates of Southern California
Huntington Beach, California 92647
United States
Loma Linda University
Loma Linda, California 92354
United States
California Retina Consultants
Santa Barbara, California 93103-4223
United States
University of Florida - Jacksonville
Jacksonville, Florida 32209
United States
Florida Retina Consultants
Lakeland, Florida 33805
United States
Ophthalmic Partners of Florida, PA dba Central Florida Retina
Orlando, Florida 32806
United States
Retina Associates of Florida, LLC
Tampa, Florida 33609
United States
Emory Eye Center
Atlanta, Georgia 30322
United States
Southeast Retina Center, P.C.
Augusta, Georgia 30909
United States
Illinois Retina Associates SC Oak Park Site
Oak Park, Illinois 60304
United States
Midwest Eye Institute
Carmel, Indiana 46032
United States
The Trustees of Indiana University
Indianapolis, Indiana 46202
United States
Wolfe Clinic, P.C.- West Des Moines
West Des Moines, Iowa 50266
United States
Mid-America Retina Consultants, P.A.
Overland, Kansas 66211
United States
University of Kentucky Advanced Eye Care
Lexington, Kentucky 40508
United States
Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana
West Monroe, Louisiana 71291-4452
United States
Elman Retina Group, P.A.
Baltimore, Maryland 21237
United States
Boston Medical Center Corporation
Boston, Massachusetts 02118
United States
Joslin Diabetes Center
Boston, Massachusetts 02215
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
Retina Consultants of Minnesota
Saint Louis Park, Minnesota 55416
United States
Retina Research Institute, LLC
St Louis, Missouri 63128
United States
Retina Associates of Western NY, P.C.
Rochester, New York 14620
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27517-8923
United States
Retina Vitreous Center
Edmond, Oklahoma 73013
United States
Retina-Vitreous Consultants, Inc.
Monroeville, Pennsylvania 15146
United States
Austin Research Center for Retina
Austin, Texas 78705
United States
Retina Consultants of Texas, PA
Bellaire, Texas 77401
United States
Baylor College of Medicine, Baylor Eye Physicians and Surgeons
Houston, Texas 77030-4101
United States
Texas Retina Associates
Lubbock, Texas 79424
United States