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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
326
125µg of ocriplasmin intravitreal injection
Intravitreal injection placebo.
Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28
Proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at Day 28, as determined by masked Central Reading Centre (CRC) Optical Coherence Tomography(OCT)evaluation.
Time frame: Day 28
Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28
Proportion of subjects with total PVD at Day 28, as determined by masked investigator assessment of B-scan ultrasound.
Time frame: Day 28
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