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Recruiting NCT06790784

Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of PDR

Conditions: Proliferative Diabetic Retinopathy (PDR)

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 426
Sponsor: Jaeb Center for Health Research

Location: Retina Associates of Southern California Huntington Beach California

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 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06790784). StuddyBuddy aggregates publicly available trial information.