This study will evaluate the safety and efficacy of Microplasmin administered as an intravitreal injection, in subjects with focal vitreomacular adhesion. Ultimately, it is believed that intravitreal microplasmin may offer physicians a safe agent for pharmacologic vitreolysis and induction of Posterior Vitreous Detachment (PVD) without the need for vitrectomy. This clinical study is justified because the study sponsor believes the potential benefits outweigh the potential risks, as outlined below.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
125 µg intravitreal injection
University Hospital Leuven
Leuven, Belgium
History/full ophthalmologic examination (including full retinal examination: baseline, post-injection days 7, 14 and 28 and months 3 and 6
Time frame: baseline, day 7, 14 and 28 and months 3 and 6
Proportion of patients with nonsurgical resolution of focal vitreomacular adhesion at study visits other than the 28 day post-injection visit
Time frame: Day 28
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