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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device, Procedure, Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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)

Locations
United States
Georgia
Southeast Retina Center, P.C.
RECRUITING
Augusta
Illinois
Illinois Retina Associates SC Oak Park Site
RECRUITING
Oak Park
Indiana
Midwest Eye Institute
RECRUITING
Carmel
New York
Retina Associates of Western NY, P.C.
RECRUITING
Rochester
Texas
Texas Retina Associates
RECRUITING
Lubbock
Contact Information
Primary
Cynthia Stockdale
drcrnet@jaeb.org
8139758690
Time Frame
Start Date: 2025-08-04
Estimated Completion Date: 2031-08
Participants
Target number of participants: 426
Treatments
Experimental: Faricimab + PRP
PRP = Panretinal Photocoagulation
Active_comparator: Vitrectomy + Endolaser
Related Therapeutic Areas
Sponsors
Collaborators: Genentech, Inc., National Eye Institute (NEI)
Leads: Jaeb Center for Health Research

This content was sourced from clinicaltrials.gov

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