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

PHASE3RecruitingINTERVENTIONAL
Enrollment

426

Participants

Timeline

Start Date

August 4, 2025

Primary Completion Date

August 31, 2031

Study Completion Date

August 31, 2031

Conditions
Proliferative Diabetic Retinopathy (PDR)
Interventions
PROCEDURE

Vitrectomy

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.

DEVICE

Endolaser

Complete panretinal photocoagulation (PRP) during vitrectomy

DRUG

Faricimab

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.

DEVICE

Panretinal Photocoagulation (PRP)

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.

Trial Locations (5)

14620

RECRUITING

Retina Associates of Western NY, P.C., Rochester

30909

RECRUITING

Southeast Retina Center, P.C., Augusta

46032

RECRUITING

Midwest Eye Institute, Carmel

60304

RECRUITING

Illinois Retina Associates SC Oak Park Site, Oak Park

79424

RECRUITING

Texas Retina Associates, Lubbock

Sponsors
All Listed Sponsors
collaborator

National Eye Institute (NEI)

NIH

collaborator

Genentech, Inc.

INDUSTRY

lead

Jaeb Center for Health Research

OTHER