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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

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ClinicalTrials.gov Identifier: NCT01287988
Recruitment Status : Completed
First Posted : February 2, 2011
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
ThromboGenics

Brief Summary:
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 or disease Intervention/treatment
Symptomatic Vitreomacular Adhesion Drug: ocriplasmin Drug: placebo

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

Study Type : Observational
Actual Enrollment : 24 participants
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.
Study Start Date : May 2011
Primary Completion Date : October 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Ocriplasmin
U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



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:


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

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