Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of PDR (NCT06790784) | Clinical Trial Compass
RecruitingPhase 3
Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of PDR
United States426 participantsStarted 2025-08-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.)
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What they're measuring
1
Visual Acuity Change from Baseline
Timeframe: Baseline to 3- years
2
Number of Post-Randomization Treatments for Proliferative Diabetic Retinopathy