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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Alcon Research

Current Primary Outcome: Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA) [ Time Frame: Day 28 ]

VMA (adhesion of the vitreous gel to the retina in an abnormally strong manner) was determined by masked Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) evaluation. Only one eye (study eye) was analyzed. Proportion of subjects is reported as a percentage.


Original Primary Outcome: Proportion of Subjects with Non-Surgical Resolution of Vitreomacular Adhesion [ Time Frame: Day 28 ]

As determined by masked Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT)


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Alcon Research

Dates:
Date Received: June 26, 2013
Date Started: July 2013
Date Completion:
Last Updated: November 2, 2015
Last Verified: November 2015