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Faricimab plus PRP versus vitrectomy with endolaser for proliferative diabetic retinopathy

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

Phase 3 Interventional Jaeb Center for Health Research · NCT06790784

This trial will test whether faricimab plus panretinal photocoagulation (PRP) or vitrectomy with endolaser gives better long-term vision and fewer follow-up treatments for adults with proliferative diabetic retinopathy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment426 (estimated)
Ages18 Years and up
SexAll
SponsorJaeb Center for Health Research Academic / other
Drugs / interventionsfaricimab
Locations20 sites (Huntington Beach, California and 19 other locations)
Trial IDNCT06790784 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) with diabetes and proliferative diabetic retinopathy that requires treatment and a best-corrected visual acuity of 20/100 (≥49 letters) or better are ideal candidates.

Not a fit: People with significant renal disease requiring dialysis or transplant, uncontrolled blood pressure (>160/100) unless treated to target, pregnant or lactating women, or those not meeting the visual acuity cutoff may not be eligible or may not benefit from participation.

Why it matters

Potential benefit: If successful, the trial could identify an approach that preserves vision while reducing the number of injections, procedures, complications, and overall care burden for people with PDR.

How similar studies have performed: Previous trials such as Protocol S showed that PRP or anti-VEGF alone can provide good long-term vision, but direct long-term comparisons between faricimab+PRP and early vitrectomy with endolaser are novel.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Huntington Beach, California and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Proliferative Diabetic Retinopathyfaricimabvitrectomyendolaserpanretinal photocoagulation
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.