Safety and Efficacy Study of Intravitreal Ocriplasmin in Subjects With AMD With Focal Vitreomacular Adhesion

Summary

This study will evaluate the safety and efficacy of Ocriplasmin intravitreal injection, in subjects diagnosed with exudative AMD with focal vitreomacular adhesion. Ultimately, it is believed that intravitreal ocriplasmin may offer physicians a safe agent for pharmacologic vitreolysis and nonsurgical resolution of focal vitreomacular adhesion in AMD subjects where this adhesion may be causally associated with worse prognosis).

Timeline

Start

2010-01

Primary completion

2012-12

Completion

2013-04

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Ocriplasmin vs Sham; p = 0.262; Difference in proportions 12.3 (95% CI -3.7 to 28.4); Fisher Exact NCT00913744 ↗

Drugs

Indications