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

NCT06790784 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 426

Last updated 2026-05-18

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • Genentech, Inc.

    collaborator INDUSTRY

  • Jaeb Center for Health Research

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-04
Primary Completion
2031-08-31
Completion
2031-08-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06790784 on ClinicalTrials.gov