Pre-operative Vabysmo in Patients With Non-clearing Vitreous Hemorrhage Secondary to Proliferative Diabetic Retinopathy

PHASE4Enrolling by invitationINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

July 12, 2024

Primary Completion Date

January 31, 2025

Study Completion Date

January 31, 2027

Conditions
Diabetic RetinopathyVitreous Hemorrhage Due to Diabetes Mellitus
Interventions
DRUG

Faricimab Injection

Pre-operative injection of bevacizumab appears to have mixed results in lowering post-operative vitreous hemorrhage. One potential reason is due to aspiration and removal of medication in the vitreous humor at the time of pars plana vitrectomy leading to less than anticipated results in controlling neovascularization and vitreous hemorrhage post-operatively. To avoid attenuation of our desired effect we plan to repeat faricimab injection post-operatively around week one.

DRUG

sham treatment

Patients will be randomized 2:1 to receive either faricimab (6 mg from 0.05 mL of a 120 mg/mL) or sham injection

Trial Locations (1)

80045

Sue Anschutz-Rodgers Eye Center, Aurora

All Listed Sponsors
lead

University of Colorado, Denver

OTHER