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

Alcon

Status and phase

Completed

Phase 3

Conditions

Symptomatic Vitreomacular Adhesion

Treatments

Drug: Ocriplasmin

Drug: Sham injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT01889251

J-12-075

Details and patient eligibility

About

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.

Enrollment

251 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.