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

Conditions

• Proliferative Diabetic Retinopathy (PDR)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Vitrectomy — PROCEDURE
  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.
• Endolaser — DEVICE
  Complete panretinal photocoagulation (PRP) during vitrectomy
• Faricimab — DRUG
  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.
• Panretinal Photocoagulation (PRP) — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Aug 4, 2025

Status verified

Sep 2025

Primary completion

Aug 31, 2031

Completion

Aug 31, 2031

Study Design

Enrollment

426 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Faricimab + PRP
  PRP = Panretinal Photocoagulation
• Active Comparator: Vitrectomy + Endolaser

Primary Outcome Measure

Visual Acuity Change from Baseline [ Time Frame: Baseline to 3- years ]

Central Contacts

• Cynthia Stockdale
  8139758690
  [email protected]

Locations (27)

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