Back to Trials
NCT06790784PHASE3Recruiting

Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of PDR

Jaeb Center for Health Research

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

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 global grading of ultrawide field fundus photos or NV meeting criteria for moderate PDR or worse 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 Criteria: * Individual: * Significant renal disease, defined as a history of chronic renal failure requiring 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 to become pregnant within the next 3 years. * Women of childbearing potential will be required to have pregnancy testing or use an acceptable method of pregnancy prevention. Women who are potential study participants should be questioned about the potential for pregnancy at baseline and prior to each injection. Pregnancy test is required for all women of childbearing potential at baseline. Investigator judgment is used to determine when a pregnancy test is needed during follow 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

Interventions

PROCEDURE

Vitrectomy

DEVICE

Endolaser

DRUG

Faricimab

DEVICE

Panretinal Photocoagulation (PRP)

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Proliferative Diabetic Retinopathy (PDR)

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