Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06790784

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

Led by Jaeb Center for Health Research · Updated on 2026-01-29

426

Participants Needed

20

Research Sites

312 weeks

Total Duration

On this page

Sponsors

J

Jaeb Center for Health Research

Lead Sponsor

N

National Eye Institute (NEI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years old or older
  • Diagnosis of diabetes mellitus (type 1 or type 2)
  • Presence of PDR requiring treatment, confirmed by central reading center
  • Best corrected visual acuity 20/100 Snellen equivalent or better (49 letters or more)
Not Eligible

You will not qualify if you...

  • History of chronic renal failure requiring dialysis or kidney transplant
  • Blood pressure above 160/100 (unless controlled below this with medication)
  • Pregnant, lactating, or intending to become pregnant within 3 years (for women of child-bearing potential)
  • Traction retinal detachment involving the macula in study eye
  • Significant vitreous hemorrhage preventing full PRP in study eye
  • Significant vitreomacular traction in study eye
  • Any prior vitrectomy in study eye
  • Prior PRP with 100 or more burns outside the posterior pole in study eye
  • Treatment for diabetic macular edema within prior 6 months in study eye
  • Intravitreal anti-VEGF for any indication other than DME within prior year in study eye

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 20 locations

1

Retina Associates of Southern California

Huntington Beach, California, United States, 92647

Actively Recruiting

2

Loma Linda University

Loma Linda, California, United States, 92354

Actively Recruiting

3

Florida Retina Consultants

Lakeland, Florida, United States, 33805

Actively Recruiting

4

Ophthalmic Partners of Florida, PA dba Central Florida Retina

Orlando, Florida, United States, 32806

Actively Recruiting

5

Retina Associates of Florida, LLC

Tampa, Florida, United States, 33609

Actively Recruiting

6

Southeast Retina Center, P.C.

Augusta, Georgia, United States, 30909

Actively Recruiting

7

Illinois Retina Associates SC Oak Park Site

Oak Park, Illinois, United States, 60304

Actively Recruiting

8

Midwest Eye Institute

Carmel, Indiana, United States, 46032

Actively Recruiting

9

Wolfe Clinic, P.C.- West Des Moines

West Des Moines, Iowa, United States, 50266

Actively Recruiting

10

Mid-America Retina Consultants, P.A.

Overland, Kansas, United States, 66211

Actively Recruiting

11

University of Kentucky Advanced Eye Care

Lexington, Kentucky, United States, 40508

Actively Recruiting

12

Elman Retina Group, P.A.

Baltimore, Maryland, United States, 21237

Actively Recruiting

13

Boston Medical Center Corporation

Boston, Massachusetts, United States, 02118

Actively Recruiting

14

Joslin Diabetes Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

15

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

16

Retina Research Institute, LLC

St Louis, Missouri, United States, 63128

Actively Recruiting

17

Retina Associates of Western NY, P.C.

Rochester, New York, United States, 14620

Actively Recruiting

18

Retina-Vitreous Consultants, Inc.

Monroeville, Pennsylvania, United States, 15146

Actively Recruiting

19

Retina Consultants of Texas, PA

Bellaire, Texas, United States, 77401

Actively Recruiting

20

Texas Retina Associates

Lubbock, Texas, United States, 79424

Actively Recruiting

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Research Team

C

Cynthia Stockdale

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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