Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of PDR
A Randomized Clinical Trial Evaluating Combination Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of Proliferative Diabetic Retinopathy
Jaeb Center for Health Research
426 participants
Aug 4, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria14
- 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
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Interventions
The vitrectomy must occur within 4 weeks of randomization. A single injection of faricimab is allowed at any point before the vitrectomy. It is recommended that this injection is within 1 week of the vitrectomy. Requirement of triamcinolone staining to assist in complete elevation and removal of the posterior hyaloid and in removal of as much peripheral vitreous as is safely possible, 20 gauge not permitted. Allows subconjunctival steroid at investigator discretion; however, sub-tenon's triamcinolone or other long-acting steroid will not be permitted.
Complete panretinal photocoagulation (PRP) during vitrectomy
Treatment must be initiated on the day of randomization with one faricumab injection. The remainder of the randomized treatment includes 2 additional injections every 4-weeks. Injections must be completed within 90 days of randomization.
Complete PRP. PRP may be completed in 1-3 sessions, with the timing at the investigator's discretion. All PRP sessions must be completed within 90 days of randomization.
Locations(20)
View Full Details on ClinicalTrials.gov
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NCT06790784