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

Launched by JAEB CENTER FOR HEALTH RESEARCH · Jan 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different treatment options for a serious eye condition called proliferative diabetic retinopathy (PDR), which can happen to people with diabetes. The trial will compare a combination treatment of faricimab (an eye injection) and pan-retinal photocoagulation (PRP, a type of laser treatment) against a surgical approach involving vitrectomy (removing some of the eye's gel-like substance) and endolaser treatment. Participants will be followed for three years to see how well their vision improves, how many treatments they need, any complications that may arise, and the overall costs of these treatment options.

To be eligible for the trial, participants must be at least 18 years old and have diabetes, with PDR that requires treatment. They should have a certain level of vision and not have other serious health issues, like severe kidney problems or high blood pressure. Women who could become pregnant will need to take precautions and undergo pregnancy tests. If you or a family member meets these criteria, this trial may provide valuable insights into the best treatment options for PDR.

Gender

ALL

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