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

NCT ID: NCT01889251

Last Updated: 2015-11-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

251 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-09-30

Brief Summary

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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

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Conditions

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Symptomatic Vitreomacular Adhesion

Keywords

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Vitreomacular Adhesion Vitreomacular Traction Vitreomacular Traction Syndrome Vitrectomy Central Visual Field Defect Blind Spot Intravitreal Injection Macula Retina Decreased Visual Acuity Visual Complaint SD-OCT Macular Hole

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ocriplasmin

Ocriplasmin administered as a single intravitreal injection to the study eye at baseline

Group Type EXPERIMENTAL

Ocriplasmin

Intervention Type DRUG

Sham injection

Single sham injection to the study eye at baseline

Group Type SHAM_COMPARATOR

Sham injection

Intervention Type DRUG

Interventions

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Ocriplasmin

Intervention Type DRUG

Sham injection

Intervention Type DRUG

Other Intervention Names

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A01016

Eligibility Criteria

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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;

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;
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Group Manager, Clinical Development

Role: STUDY_DIRECTOR

Alcon Japan, Ltd.

Locations

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Contact Alcon for Trial Locations

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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J-12-075

Identifier Type: -

Identifier Source: org_study_id