Faricimab plus PRP versus vitrectomy with endolaser for proliferative diabetic retinopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized Phase 3 trial compares two treatment strategies for proliferative diabetic retinopathy (PDR): intravitreal faricimab combined with panretinal photocoagulation (PRP) versus primary vitrectomy with endolaser. Eligible adults with PDR will be randomized to one of the two approaches and followed for three years. Key outcomes include best-corrected visual acuity at 3 years, number of subsequent treatments (injections, PRP, vitrectomy), complications such as vitreous hemorrhage or tractional retinal detachment, and overall cost and visit burden. The trial uses centralized imaging grading to confirm PDR and standardizes post-randomization management to compare long-term safety and treatment burden.

Why it matters

Who can join: the full rules

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

Where it's running

• Retina Associates of Southern California
  Huntington Beach, California, United States Recruiting
• Loma Linda University
  Loma Linda, California, United States Recruiting
• West Coast Retina Medical Group, Inc.
  San Francisco, California, United States Recruiting
• California Retina Consultants
  Santa Barbara, California, United States Recruiting
• University of Florida - Jacksonville
  Jacksonville, Florida, United States Recruiting
• Florida Retina Consultants
  Lakeland, Florida, United States Recruiting

Study contacts

• Study coordinator: Cynthia Stockdale
• Email: drcrnet@jaeb.org
• Phone: 8139758690

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Feasibility of trained non-medical professionals performing laser treatment for PDR and impact on service delivery

  This study tests whether trained eye care professionals can safely perform laser treatment for proliferative diabetic retinopathy and whether using them could increase clinic capacity.

  Recruiting Swansea Bay University Health Board · Swansea · NCT07923292

• Faricimab for CNV in Presumed Ocular Histoplasmosis Syndrome

  This study tests whether Faricimab can safely and effectively treat choroidal neovascularization linked to presumed ocular histoplasmosis in adults over a 52-week period.

  Recruiting at 2 sites Phase 4 Cincinnati Eye Institute, Southwest Ohio · Cincinnati, Ohio and 1 other locations · NCT07695298

• Early vitrectomy with PRP for early proliferative diabetic retinopathy

  Tests whether early microincision vitrectomy surgery combined with PRP can improve regrowth of abnormal blood vessels and vision in people with early proliferative diabetic retinopathy.

  Recruiting Xiamen Ophthalmology Center Affiliated to Xiamen University · Beijing, Beijing Municipality and 5 other locations · NCT07586787

• Early imaging changes with faricimab versus biosimilar ranibizumab for diabetic retinal disease

  This trial will see if faricimab or a biosimilar ranibizumab causes different early OCT and OCTA imaging changes in adults with diabetic retinopathy or diabetic macular edema who need anti-VEGF injections.

  Recruiting Osijek University Hospital · Osijek · NCT07520045

• Personalized treat-and-extend faricimab regimen for treatment-naive polypoidal choroidal vasculopathy

  This tests whether a personalized treat-and-extend dosing schedule of faricimab (Vabysmo) helps people with newly diagnosed polypoidal choroidal vasculopathy keep or improve their vision.

  Recruiting Phase 3 Yeungnam University College of Medicine · Daegu, Namgu · NCT07461441

• RO7823653 injections, alone or with faricimab, for diabetic macular edema

  This research tests injections of RO7823653, given alone or with faricimab, in people with diabetic macular edema to see if the medication is safe and how the eye handles it.

  Recruiting at 12 sites Phase 1 Genentech, Inc. · Peoria, Arizona and 11 other locations · NCT07425522

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.