Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of PDR
AP
A Randomized Clinical Trial Evaluating Combination Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of Proliferative Diabetic Retinopathy
2 other identifiers
interventional
426
1 country
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2025
Longer than P75 for phase_3
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2025
CompletedFirst Posted
Study publicly available on registry
January 24, 2025
CompletedStudy Start
First participant enrolled
August 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2031
January 29, 2026
September 1, 2025
6 years
January 10, 2025
January 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Visual Acuity Change from Baseline
Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40.
Baseline to 3- years
Number of Post-Randomization Treatments for Proliferative Diabetic Retinopathy
Initial randomized treatment will be excluded.
Over 3 Years
Study Arms (2)
Faricimab + PRP
EXPERIMENTALPRP = Panretinal Photocoagulation
Vitrectomy + Endolaser
ACTIVE COMPARATORInterventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.collaborator
- Jaeb Center for Health Researchlead
- National Eye Institute (NEI)collaborator
Study Sites (20)
Retina Associates of Southern California
Huntington Beach, California, 92647, United States
Loma Linda University
Loma Linda, California, 92354, United States
Florida Retina Consultants
Lakeland, Florida, 33805, United States
Ophthalmic Partners of Florida, PA dba Central Florida Retina
Orlando, Florida, 32806, United States
Retina Associates of Florida, LLC
Tampa, Florida, 33609, United States
Southeast Retina Center, P.C.
Augusta, Georgia, 30909, United States
Illinois Retina Associates SC Oak Park Site
Oak Park, Illinois, 60304, United States
Midwest Eye Institute
Carmel, Indiana, 46032, United States
Wolfe Clinic, P.C.- West Des Moines
West Des Moines, Iowa, 50266, United States
Mid-America Retina Consultants, P.A.
Overland, Kansas, 66211, United States
University of Kentucky Advanced Eye Care
Lexington, Kentucky, 40508, United States
Elman Retina Group, P.A.
Baltimore, Maryland, 21237, United States
Boston Medical Center Corporation
Boston, Massachusetts, 02118, United States
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Retina Research Institute, LLC
St Louis, Missouri, 63128, United States
Retina Associates of Western NY, P.C.
Rochester, New York, 14620, United States
Retina-Vitreous Consultants, Inc.
Monroeville, Pennsylvania, 15146, United States
Retina Consultants of Texas, PA
Bellaire, Texas, 77401, United States
Texas Retina Associates
Lubbock, Texas, 79424, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2025
First Posted
January 24, 2025
Study Start
August 4, 2025
Primary Completion (Estimated)
August 1, 2031
Study Completion (Estimated)
August 1, 2031
Last Updated
January 29, 2026
Record last verified: 2025-09