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

Last updated: January 27, 2026
Sponsor: Jaeb Center for Health Research
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetic Retinopathy

Retina

Treatment

Vitrectomy

Faricimab

Panretinal Photocoagulation (PRP)

Clinical Study ID

NCT06790784
Protocol AP
UG1EY014231
  • Ages > 18
  • All Genders

Study 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.

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

Total Participants: 426
Treatment Group(s): 4
Primary Treatment: Vitrectomy
Phase: 3
Study Start date:
August 04, 2025
Estimated Completion Date:
August 31, 2031

Study 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.

Connect with a study center

  • Retina Associates of Southern California

    Huntington Beach 5358705, California 5332921 92647
    United States

    Active - Recruiting

  • Loma Linda University

    Loma Linda 5367696, California 5332921 92354
    United States

    Active - Recruiting

  • Florida Retina Consultants

    Lakeland 4161438, Florida 4155751 33805
    United States

    Active - Recruiting

  • Ophthalmic Partners of Florida, PA dba Central Florida Retina

    Orlando 4167147, Florida 4155751 32806
    United States

    Active - Recruiting

  • Retina Associates of Florida, LLC

    Tampa 4174757, Florida 4155751 33609
    United States

    Active - Recruiting

  • Southeast Retina Center, P.C.

    Augusta 4180531, Georgia 4197000 30909
    United States

    Active - Recruiting

  • Illinois Retina Associates SC Oak Park Site

    Oak Park 4904381, Illinois 4896861 60304
    United States

    Active - Recruiting

  • Midwest Eye Institute

    Carmel 4255466, Indiana 4921868 46032
    United States

    Active - Recruiting

  • Wolfe Clinic, P.C.- West Des Moines

    West Des Moines 4881346, Iowa 4862182 50266
    United States

    Active - Recruiting

  • Mid-America Retina Consultants, P.A.

    Overland, Kansas 4273857 66211
    United States

    Active - Recruiting

  • University of Kentucky Advanced Eye Care

    Lexington 4297983, Kentucky 6254925 40508
    United States

    Active - Recruiting

  • Elman Retina Group, P.A.

    Baltimore 4347778, Maryland 4361885 21237
    United States

    Active - Recruiting

  • Boston Medical Center Corporation

    Boston 4930956, Massachusetts 6254926 02118
    United States

    Active - Recruiting

  • Joslin Diabetes Center

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Active - Recruiting

  • Retina Research Institute, LLC

    St Louis 4407066, Missouri 4398678 63128
    United States

    Active - Recruiting

  • Retina Associates of Western NY, P.C.

    Rochester 5134086, New York 5128638 14620
    United States

    Active - Recruiting

  • Retina-Vitreous Consultants, Inc.

    Monroeville 5201734, Pennsylvania 6254927 15146
    United States

    Active - Recruiting

  • Retina Consultants of Texas, PA

    Bellaire 4673353, Texas 4736286 77401
    United States

    Active - Recruiting

  • Texas Retina Associates

    Lubbock 5525577, Texas 4736286 79424
    United States

    Active - Recruiting

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