A Randomized, Double-masked, Sham-controlled Study to Evaluate the Efficacy of Peri-operative Farcimab in Patients With Non-clearing Vitreous Hemorrhage Secondary to Proliferative Diabetic Retinopathy

NCT06191094 Phase 4 ENROLLING_BY_INVITATION

In this phase IV, randomized, double-masked, sham-controlled study the investigators hope to determine the efficacy in peri-operative faricimab (Vabysmo) compared to sham in limiting complications from pars plana vitrectomy for diabetic vitreous hemorrhage with or without tractional retinal detachments.

Details

Lead sponsor	University of Colorado, Denver
Phase	Phase 4
Status	ENROLLING_BY_INVITATION
Enrolment	100
Start date	2024-07-12
Completion	2027-01

Conditions

• Diabetic Retinopathy
• Vitreous Hemorrhage Due to Diabetes Mellitus

Interventions

• Faricimab Injection
• sham treatment

Primary outcomes

• Rates of post-operative vitreous hemorrhage — 6 months
  Following treatment and surgery, the development of vitreous hemorrhage will be quantified and evaluated.

Countries

United States