Conditions: Vitreomacular Adhesion
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 326
Healthy volunteers: no

Brief summary:
This trial will evaluate the safety and efficacy of microplasmin, administered as an intravitreal injection, in subjects with focal vitreomacular adhesion. In previously performed clinical trials, some patients treated with intravitreal microplasmin have had resolution of their underlying condition, including macular hole closure, without need for vitrectomy. This clinical trial is justified because the sponsor believes the potential benefits outweigh the potential risks.

Detailed description:

Arms:
arm 1: 125µg of ocriplasmin intravitreal injection arm 2: Intravitreal injection of placebo

Interventions: intervention 1: Ocriplasmin 125µg intervention 2: Placebo
Intervention descriptions: intervention 1: 125µg of ocriplasmin intravitreal injection intervention 2: Intravitreal injection placebo.

Protocol document: