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

Recruiting now · Phase 3

Conditions studied: Proliferative Diabetic Retinopathy (PDR)

In brief

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.

Key facts

Study ID

NCT06790784

Run by

Jaeb Center for Health Research

People needed

426

Starts

2025-08-04

Expected to finish

2031-08-01

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Retina Associates of Southern California — Huntington Beach, California, United States (enrolling)
• Loma Linda University — Loma Linda, California, United States (enrolling)
• California Retina Consultants — Santa Barbara, California, United States (enrolling)
• University of Florida - Jacksonville — Jacksonville, Florida, United States (enrolling)
• Florida Retina Consultants — Lakeland, Florida, United States (enrolling)
• Ophthalmic Partners of Florida, PA dba Central Florida Retina — Orlando, Florida, United States (enrolling)
• Retina Associates of Florida, LLC — Tampa, Florida, United States (enrolling)
• Emory Eye Center — Atlanta, Georgia, United States (enrolling)
• Southeast Retina Center, P.C. — Augusta, Georgia, United States (enrolling)
• Illinois Retina Associates SC Oak Park Site — Oak Park, Illinois, United States (enrolling)
• Midwest Eye Institute — Carmel, Indiana, United States (enrolling)
• The Trustees of Indiana University — Indianapolis, Indiana, United States (enrolling)
• Wolfe Clinic, P.C.- West Des Moines — West Des Moines, Iowa, United States (enrolling)
• Mid-America Retina Consultants, P.A. — Overland, Kansas, United States (enrolling)
• University of Kentucky Advanced Eye Care — Lexington, Kentucky, United States (enrolling)
• Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana — West Monroe, Louisiana, United States (enrolling)
• Elman Retina Group, P.A. — Baltimore, Maryland, United States (enrolling)
• Boston Medical Center Corporation — Boston, Massachusetts, United States (enrolling)
• Joslin Diabetes Center — Boston, Massachusetts, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Retina Consultants of Minnesota — Saint Louis Park, Minnesota, United States (enrolling)
• Retina Research Institute, LLC — St Louis, Missouri, United States (enrolling)
• Retina Associates of Western NY, P.C. — Rochester, New York, United States (enrolling)
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• Retina Vitreous Center — Edmond, Oklahoma, United States (enrolling)

Full record on ClinicalTrials.gov

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