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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01287988
First Posted: February 2, 2011
Last Update Posted: January 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ThromboGenics
  Purpose
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).

Condition Intervention
Symptomatic Vitreomacular Adhesion Drug: ocriplasmin Drug: placebo

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by ThromboGenics:

Primary Outcome Measures:
  • Evidence of clinically significant abnormality in visual function, including Best Corrected Visual Acuity (BCVA), Spectral Domain Optical Coherence Tomography (SD-OCT) abnormality, and/or Electroretinography (ERG) abnormality [ Time Frame: Visit 1 ]
    Consenting patients will attend one visit, at which an ocular history, visual acuity (ETDRS) and full ophthalmologic assessment, as well as SD-OCT, and ERG assessment will be obtained. All SD-OCTs and ERGs will be centrally read by a masked and independent central reader.


Enrollment: 24
Study Start Date: May 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)
Drug: 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
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)
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have previously participated in either of the ocriplasmin Phase III studies (TG-MV-006 or TG-MV-007)
Criteria

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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01287988


Locations
United States, Texas
Retinal Consultants of Houston
Houston, Texas, United States
Belgium
Universitaire Ziekenhuizen K.U. Leuven
Leuven, Belgium
Sponsors and Collaborators
ThromboGenics
  More Information

Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT01287988     History of Changes
Other Study ID Numbers: TG-MV-012
First Submitted: January 24, 2011
First Posted: February 2, 2011
Last Update Posted: January 13, 2017
Last Verified: April 2014