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

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research

Criteria

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.