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

RecruitingPhase 3

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Jaeb Center for Health Research · Participants: 426 · Started: Aug 4, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06790784

Locations in the U.S.

CaliforniaRetina Associates of Southern California, Huntington Beach
Loma Linda University, Loma Linda
West Coast Retina Medical Group, Inc., San Francisco
California Retina Consultants, Santa Barbara
FloridaUniversity of Florida - Jacksonville, Jacksonville
Florida Retina Consultants, Lakeland
Ophthalmic Partners of Florida, PA dba Central Florida Retina, Orlando
Retina Associates of Florida, LLC, Tampa
GeorgiaEmory Eye Center, Atlanta
Southeast Retina Center, P.C., Augusta
Thomas Eye Group, Sandy Springs
IllinoisRush University Medical Center, Chicago
Illinois Retina Associates SC Oak Park Site, Oak Park
IndianaMidwest Eye Institute, Carmel
The Trustees of Indiana University, Indianapolis
IowaWolfe Clinic, P.C.- West Des Moines, West Des Moines
KansasMid-America Retina Consultants, P.A., Overland
KentuckyUniversity of Kentucky Advanced Eye Care, Lexington
LouisianaJoseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana, West Monroe
MarylandElman Retina Group, P.A., Baltimore
MassachusettsBoston Medical Center Corporation, Boston
Joslin Diabetes Center, Boston
MinnesotaMayo Clinic, Rochester
Retina Consultants of Minnesota, Saint Louis Park
MissouriRetina Research Institute, LLC, St Louis
New YorkRetina Associates of Western NY, P.C., Rochester
North CarolinaUniversity of North Carolina at Chapel Hill, Chapel Hill
OklahomaRetina Vitreous Center, Edmond
PennsylvaniaRetina-Vitreous Consultants, Inc., Monroeville
TexasAustin Research Center for Retina, Austin
Retina Consultants of Texas, PA, Bellaire
UT Southwestern Medical Center, Dallas
Baylor College of Medicine, Baylor Eye Physicians and Surgeons, Houston
Texas Retina Associates, Lubbock

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.