Recruiting
Phase 3

Faricimab & PRP vs. Vitrectomy & Endolaser

Sponsor:

Jaeb Center for Health Research

Code:

NCT06790784

Conditions

Proliferative Diabetic Retinopathy (PDR)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vitrectomy

Endolaser

Faricimab

Panretinal Photocoagulation (PRP)

Study Details

Brief 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.

Conditions

Proliferative Diabetic Retinopathy (PDR)

Study ID

NCT06790784

Start date

Aug 4, 2025

Status verified date

Sep, 2025

Completion date

Aug, 2031

Anticipated

Primary completion date

Aug, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

426 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Faricimab + PRP

PRP = Panretinal Photocoagulation

active comparator: Vitrectomy + Endolaser

Interventions

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.

Endolaser

Complete panretinal photocoagulation (PRP) during vitrectomy

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.

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.

Primary outcome measure

  • Visual Acuity Change from Baseline [ Time Frame: Baseline to 3- years ]
  • Number of Post-Randomization Treatments for Proliferative Diabetic Retinopathy [ Time Frame: Over 3 Years ]

Central Contacts and Locations

Central contacts

Cynthia Stockdale

8139758690drcrnet@jaeb.org

Locations

Retina Associates of Southern California

Recruiting

Huntington Beach, California, United States, 92647

Contacts

Hani Salehi-Had, MD

657-227-9496v.phan@retinasocal.com

Loma Linda University

Recruiting

Loma Linda, California, United States, 92354

Contacts

David I. Sierpina, MD

909-558-2169nborntrager@llu.edu

California Retina Consultants

Recruiting

Santa Barbara, California, United States, 93103-4223

Contacts

Dante J. Pieramici, MD

805-963-1648Nancyc@californiaretina.com

University of Florida - Jacksonville

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

Sandeep Grover, MD

904-244-9361ghulam.hamdani@jax.ufl.edu

Florida Retina Consultants

Recruiting

Lakeland, Florida, United States, 33805

Contacts

Scott M. Friedman, MD

863-682-7474Dfagan@frc2020.com

Ophthalmic Partners of Florida, PA dba Central Florida Retina

Recruiting

Orlando, Florida, United States, 32806

Contacts

Gokul Kumar, MD

407-425-7188vbell@cfretina.com

Retina Associates of Florida, LLC

Recruiting

Tampa, Florida, United States, 33609

Contacts

Ivan J. Suner, MD

813-875-6373retinaklongworth@gmail.com

Emory Eye Center

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Andrew M Hendrick, MD

404-778-4261mafif@emory.edu

Southeast Retina Center, P.C.

Recruiting

Augusta, Georgia, United States, 30909

Contacts

Dennis M. Marcus, MD

(706) 650-0061amitchell@southeastretina.com

Thomas Eye Group

Recruiting

Sandy Springs, Georgia, United States, 30328

Contacts

Paul L Kaufman, MD

404-256-1507kathyw@thomaseye.com

Illinois Retina Associates SC Oak Park Site

Recruiting

Oak Park, Illinois, United States, 60304

Contacts

Naryan S. Sabherwal, MD

708-660-8450vruiz@illinoisretina.com

Midwest Eye Institute

Recruiting

Carmel, Indiana, United States, 46032

Contacts

Raj K. Maturi, MD

317-817-1414haydenb@midwesteye.com

The Trustees of Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Amir R. Hajrasouliha, MD

317-944-2020skarra@iu.edu

Wolfe Clinic, P.C.- West Des Moines

Recruiting

West Des Moines, Iowa, United States, 50266

Contacts

David J. Massop

515-223-8685twoehl@wolfeclinic.com

Mid-America Retina Consultants, P.A.

Recruiting

Overland, Kansas, United States, 66211

Contacts

William N. Rosenthal, MD

(913) 663-5900sjohnson@midamericaretina.com

University of Kentucky Advanced Eye Care

Recruiting

Lexington, Kentucky, United States, 40508

Contacts

Leanne M. Clevenger, MD

8595623570evelyn.Gonzalez@uky.edu

Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana

Recruiting

West Monroe, Louisiana, United States, 71291-4452

Contacts

Ruben A. Grigorian

318-325-2610lbmoore@eyenela.com

Elman Retina Group, P.A.

Recruiting

Baltimore, Maryland, United States, 21237

Contacts

Michael J. Elman, MD

410-686-3000Starr@elmanretina.com

Boston Medical Center Corporation

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Nicole H. Siegel, MD

617-414-4020sreevardhan.alluri@bmc.org

Joslin Diabetes Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Jennifer K Sun, MD, MPH

617-309-2520cashrafz@joslin.harvard.edu

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Andrew J. Barkmeier, MD

507-538-8119Taylor.Laura2@mayo.edu

Retina Consultants of Minnesota

Recruiting

Saint Louis Park, Minnesota, United States, 55416

Contacts

Abdhish R. Bhavsar, MD

612-871-2292agilchrist@RetinaMN.com

Retina Research Institute, LLC

Recruiting

St Louis, Missouri, United States, 63128

Contacts

Kevin J. Blinder, MD

314-367-1181rhonda.weeks@rc-stl.com

Retina Associates of Western NY, P.C.

Recruiting

Rochester, New York, United States, 14620

Contacts

Edward F. Hall, MD

585-442-3411mdoran@retinaassociatesofwny.com

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27517-8923

Contacts

Jan N. Ulrich, MD

919-966-5296wrena@email.unc.edu

Retina Vitreous Center

Recruiting

Edmond, Oklahoma, United States, 73013

Contacts

Sandeep N. Shah

(405) 607-6699bell@rvcoklahoma.com

Retina-Vitreous Consultants, Inc.

Recruiting

Monroeville, Pennsylvania, United States, 15146

Contacts

Shripaad Shukla, MD

412-683-5300merlottil@retinapittsburgh.com

Austin Research Center for Retina

Recruiting

Austin, Texas, United States, 78705

Contacts

Chirag Jhaveri, MD

737-704-0130beatris.ramirez@nvisioncenters.com

Retina Consultants of Texas, PA

Recruiting

Bellaire, Texas, United States, 77401

Contacts

Hasenin Al-Khersan, MD

713-524-3434rebecca.clark@retinaconsultantstexas.com

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Yu-Guang He, MD

214-645-2012norma.ortegon@utsouthwestern.edu

Baylor College of Medicine, Baylor Eye Physicians and Surgeons

Recruiting

Houston, Texas, United States, 77030-4101

Contacts

Christina Y Weng, MD, MBA

713-798-3493Peter.Rico@bcm.edu

Texas Retina Associates

Recruiting

Lubbock, Texas, United States, 79424

Contacts

Michel Shami, MD

806-792-0066afuller@texasretina.com

More Information

Sponsor

Jaeb Center for Health Research

Last update posted

Aug 20, 2026

Last verified

Sep, 2025

Keywords

  • faricimab
  • vitrectomy
  • endolaser
  • panretinal photocoagulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jaeb Center for Health Research on 2026-08-20.