A Phase III Study of A01016 in Subjects With Symptomatic Vitreomacular Adhesion

A Phase III Study of A01016 125μg Intravitreal Injection in Subjects With Symptomatic Vitreomacular Adhesion - Comparison Study to Sham Injection

The purpose of this study is to evaluate the superiority regarding vitreomacular adhesion (VMA) resolution of a single intravitreal injection of A01016 (Ocriplasmin) compared to sham-injection in subjects with symptomatic VMA.

Inclusion Criteria:

• Symptomatic vitreomacular adhesion (VMA) which, in the opinion of the Investigator, is related to decreased visual function;
• Best corrected visual acuity (BCVA) of 20/25 or worse in the study eye;
• BCVA of 20/800 or better in the non-study eye;
• Provide written informed consent;
• Follow specified instructions during study period;
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Evidence of proliferative retinopathy, exudative age-related macular degeneration, or retinal vein occlusion in the study eye;
• Vitreous hemorrhage or other opacification;
• High myopia in the study eye;
• Ocular surgery, laser photocoagulation treatment, or intravitreal injection(s) in the study eye in the prior 3 months;
• Uncontrolled glaucoma in the study eye;
• History of retinal detachment in either eye;
• Active infection in either eye;
• Pregnant or of child-bearing potential and not utilizing acceptable form of contraception;
• Participation in another investigational drug study within 30 days prior to this study;
• Other protocol-defined exclusion criteria may apply.