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

Phase 3

Completed

• Conditions: Symptomatic Vitreomacular Adhesion
• Interventions: Drug: Sham injection; Drug: Ocriplasmin

• Registration Number: NCT01889251
• Lead Sponsor: Alcon Research

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 Description

Not available

Study Timeline

• Study First Submitted: 2013-06-26
• Study First Submitted QC: 2013-06-26
• Study First Posted: 2013-06-28
• Study Start: 2013-07
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Results First Submitted: 2015-09-30
• Results First Submitted QC: 2015-09-30
• Results First Posted: 2015-10-29
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham injection	Sham injection	Single sham injection to the study eye at baseline
Ocriplasmin	Ocriplasmin	Ocriplasmin administered as a single intravitreal injection to the study eye at baseline

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA)	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.

Trial Locations

Locations (1)

Contact Alcon for Trial Locations; 🇯🇵 Tokyo, Japan