Compares two treatments for proliferative diabetic retinopathy, an eye disease caused by diabetes
Tests faricimab with laser treatment against surgery in adults with proliferative diabetic retinopathy.
Plain-language title generated from the registry record
Registry title: Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of PDR
Key facts
- Where
- Atlanta, Augusta, Austin, Baltimore, Bellaire, Boston, Carmel, Chapel Hill, Chicago, Dallas, Edmond, Houston, Huntington Beach, Indianapolis, Jacksonville, Lakeland, Lexington, Loma Linda, Lubbock, Monroeville, Oak Park, Orlando, Overland, Rochester, Saint Louis Park, San Francisco, Sandy Springs, Santa Barbara, St Louis, Tampa, West Des Moines, and West Monroe, United StatesSee the 34 sites
- Phase
- Phase 3
Where in United States
- Emory Eye CenterAtlanta, United StatesTaking people
- Southeast Retina Center, P.C.Augusta, United StatesTaking people
- Austin Research Center for RetinaAustin, United StatesTaking people
- Elman Retina Group, P.A.Baltimore, United StatesTaking people
- Retina Consultants of Texas, PABellaire, United StatesTaking people
- Boston Medical Center CorporationBoston, United StatesTaking people
- Joslin Diabetes CenterBoston, United StatesTaking people
- Midwest Eye InstituteCarmel, United StatesTaking people
- University of North Carolina at Chapel HillChapel Hill, United StatesTaking people
- Rush University Medical CenterChicago, United StatesTaking people
- UT Southwestern Medical CenterDallas, United StatesTaking people
- Retina Vitreous CenterEdmond, United StatesTaking people
- Baylor College of Medicine, Baylor Eye Physicians and SurgeonsHouston, United StatesTaking people
- Retina Associates of Southern CaliforniaHuntington Beach, United StatesTaking people
- The Trustees of Indiana UniversityIndianapolis, United StatesTaking people
- University of Florida - JacksonvilleJacksonville, United StatesTaking people
- Florida Retina ConsultantsLakeland, United StatesTaking people
- University of Kentucky Advanced Eye CareLexington, United StatesTaking people
- Loma Linda UniversityLoma Linda, United StatesTaking people
- Texas Retina AssociatesLubbock, United StatesTaking people
- Retina-Vitreous Consultants, Inc.Monroeville, United StatesTaking people
- Illinois Retina Associates SC - Oak Park SiteOak Park, United StatesTaking people
- Ophthalmic Partners of Florida, PA dba Central Florida RetinaOrlando, United StatesTaking people
- Mid-America Retina Consultants, P.A.Overland, United StatesTaking people
- Mayo ClinicRochester, United StatesTaking people
- Retina Associates of Western NY, P.C.Rochester, United StatesTaking people
- Retina Consultants of MinnesotaSaint Louis Park, United StatesTaking people
- West Coast Retina Medical Group, Inc.San Francisco, United StatesTaking people
- Thomas Eye GroupSandy Springs, United StatesTaking people
- California Retina ConsultantsSanta Barbara, United StatesTaking people
- Retina Research Institute, LLCSt Louis, United StatesTaking people
- Retina Associates of Florida, LLCTampa, United StatesTaking people
- Wolfe Clinic, P.C.- West Des MoinesWest Des Moines, United StatesTaking people
- Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast LouisianaWest Monroe, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jaeb Center for Health Research
- Trial code
- NCT06790784
- Record updated
- 18 September 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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.); 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; Significant vitreous hemorrhage that would preclude completion of a full PRP; Traction retinal detachment involving the macula; Significant vitreomacular traction.