Follow-up Study to Assess Visual Function in Subset of Patients Who Have Previously Participated in the TG-MV-006 and TG-MV-007 Ocriplasmin Studies

NCT ID: NCT01287988

Last Updated: 2017-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-10-31

Brief Summary

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The primary objective of this study is to assess visual function in up to 44 patients who have previously participated in either of the placebo controlled, ocriplasmin Phase III studies (TG-MV-006 or TG-MV-007).

Detailed Description

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Non-interventional follow up study consisting of 1 patient visit to perform assessments to assess long term visual function

Conditions

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Symptomatic Vitreomacular Adhesion

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Ocriplasmin

Subjects who were exposed to a single intravitreal injection of 125µg of ocriplasmin in a previous phase III study (TG-MV-006 or TG-MV-007)

ocriplasmin

Intervention Type DRUG

Subjects were exposed to a single intravitreal injection of 125µg of ocriplasmin in a previous phase III study TG-MV-006 or TG-MV-007

Placebo

Subjects who were exposed to a single intravitreal injection of placebo in a previous phase III study (TG-MV-006 or TG-MV-007)

placebo

Intervention Type DRUG

Subjects were exposed to a single intravitreal injection of placebo in a previous phase III study TG-MV-006 or TG-MV-007

Interventions

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ocriplasmin

Subjects were exposed to a single intravitreal injection of 125µg of ocriplasmin in a previous phase III study TG-MV-006 or TG-MV-007

Intervention Type DRUG

placebo

Subjects were exposed to a single intravitreal injection of placebo in a previous phase III study TG-MV-006 or TG-MV-007

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Written informed consent obtained from the patient prior to inclusion in the follow-up study
* Previous participation in either of the placebo controlled, ocriplasmin Phase III studies (TG-MV-006 or TG-MV-007)

Exclusion Criteria

* N/A
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ThromboGenics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Retinal Consultants of Houston

Houston, Texas, United States

Site Status

Universitaire Ziekenhuizen K.U. Leuven

Leuven, , Belgium

Site Status

Countries

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United States Belgium

Other Identifiers

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TG-MV-012

Identifier Type: -

Identifier Source: org_study_id

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