Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06790784
PHASE3

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

Sponsor: Jaeb Center for Health Research

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

426

Start Date

2025-08-04

Completion Date

2031-08

Last Updated

2026-01-29

Healthy Volunteers

No

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.

Locations (20)

Retina Associates of Southern California

Huntington Beach, California, United States

Loma Linda University

Loma Linda, California, United States

Florida Retina Consultants

Lakeland, Florida, United States

Ophthalmic Partners of Florida, PA dba Central Florida Retina

Orlando, Florida, United States

Retina Associates of Florida, LLC

Tampa, Florida, United States

Southeast Retina Center, P.C.

Augusta, Georgia, United States

Illinois Retina Associates SC Oak Park Site

Oak Park, Illinois, United States

Midwest Eye Institute

Carmel, Indiana, United States

Wolfe Clinic, P.C.- West Des Moines

West Des Moines, Iowa, United States

Mid-America Retina Consultants, P.A.

Overland, Kansas, United States

University of Kentucky Advanced Eye Care

Lexington, Kentucky, United States

Elman Retina Group, P.A.

Baltimore, Maryland, United States

Boston Medical Center Corporation

Boston, Massachusetts, United States

Joslin Diabetes Center

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Retina Research Institute, LLC

St Louis, Missouri, United States

Retina Associates of Western NY, P.C.

Rochester, New York, United States

Retina-Vitreous Consultants, Inc.

Monroeville, Pennsylvania, United States

Retina Consultants of Texas, PA

Bellaire, Texas, United States

Texas Retina Associates

Lubbock, Texas, United States