Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of PDR (AP)

May 15, 2026 updated by: Jaeb Center for Health Research

A Randomized Clinical Trial Evaluating Combination Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of Proliferative Diabetic Retinopathy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

426

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Huntington Beach, California, United States, 92647
        • Recruiting
        • Retina Associates of Southern California
        • Contact:
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Loma Linda University
        • Contact:
      • Santa Barbara, California, United States, 93103-4223
        • Recruiting
        • California Retina Consultants
        • Contact:
    • Florida
      • Lakeland, Florida, United States, 33805
        • Recruiting
        • Florida Retina Consultants
        • Contact:
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Ophthalmic Partners of Florida, PA dba Central Florida Retina
        • Contact:
      • Tampa, Florida, United States, 33609
        • Recruiting
        • Retina Associates of Florida, LLC
        • Contact:
    • Georgia
      • Augusta, Georgia, United States, 30909
    • Illinois
      • Oak Park, Illinois, United States, 60304
        • Recruiting
        • Illinois Retina Associates SC Oak Park Site
        • Contact:
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Recruiting
        • Midwest Eye Institute
        • Contact:
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • The Trustees of Indiana University
        • Contact:
          • Amir R. Hajrasouliha, MD
          • Phone Number: 317-944-2020
          • Email: skarra@iu.edu
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Recruiting
        • Wolfe Clinic, P.C.- West Des Moines
        • Contact:
    • Kansas
      • Overland, Kansas, United States, 66211
        • Recruiting
        • Mid-America Retina Consultants, P.A.
        • Contact:
    • Kentucky
      • Lexington, Kentucky, United States, 40508
        • Recruiting
        • University of Kentucky Advanced Eye Care
        • Contact:
    • Louisiana
      • West Monroe, Louisiana, United States, 71291-4452
        • Recruiting
        • Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Recruiting
        • Elman Retina Group, P.A.
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center Corporation
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • Retina Consultants of Minnesota
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63128
        • Recruiting
        • Retina Research Institute, LLC
        • Contact:
    • New York
      • Rochester, New York, United States, 14620
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Recruiting
        • Retina Vitreous Center
        • Contact:
    • Pennsylvania
      • Monroeville, Pennsylvania, United States, 15146
    • Texas
      • Austin, Texas, United States, 78705
      • Bellaire, Texas, United States, 77401
      • Houston, Texas, United States, 77030-4101
        • Recruiting
        • Baylor College of Medicine, Baylor Eye Physicians and Surgeons
        • Contact:
      • Lubbock, Texas, United States, 79424
        • Recruiting
        • Texas Retina Associates
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Faricimab + PRP
PRP = Panretinal Photocoagulation
Drug: Faricimab
Treatment must be initiated on the day of randomization with one faricumab injection. The remainder of the randomized treatment includes 2 additional injections every 4-weeks. Injections must be completed within 90 days of randomization.
Device: Panretinal Photocoagulation (PRP)
Complete PRP. PRP may be completed in 1-3 sessions, with the timing at the investigator's discretion. All PRP sessions must be completed within 90 days of randomization.
Active Comparator: Vitrectomy + Endolaser
Procedure: Vitrectomy
The vitrectomy must occur within 4 weeks of randomization. A single injection of faricimab is allowed at any point before the vitrectomy. It is recommended that this injection is within 1 week of the vitrectomy. Requirement of triamcinolone staining to assist in complete elevation and removal of the posterior hyaloid and in removal of as much peripheral vitreous as is safely possible, 20 gauge not permitted. Allows subconjunctival steroid at investigator discretion; however, sub-tenon's triamcinolone or other long-acting steroid will not be permitted.
Device: Endolaser
Complete panretinal photocoagulation (PRP) during vitrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity Change from Baseline
Time Frame: Baseline to 3- years
Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40.
Baseline to 3- years
Number of Post-Randomization Treatments for Proliferative Diabetic Retinopathy
Time Frame: Over 3 Years
Initial randomized treatment will be excluded.
Over 3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaeb Center for Health Research

Collaborators

National Eye Institute (NEI)
Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2025

Primary Completion (Estimated)

August 1, 2031

Study Completion (Estimated)

August 1, 2031

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

January 23, 2025

First Posted (Actual)

January 24, 2025

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol AP
  • UG1EY014231 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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