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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:
Information provided by (Responsible Party):
ThromboGenics
ClinicalTrials.gov Identifier:
NCT01287988
First received: January 24, 2011
Last updated: March 5, 2013
Last verified: May 2012
History of Changes
  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

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:

MedlinePlus related topics: Adhesions
Drug Information available for: Ocriplasmin
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    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)
Intervention Details:
    Drug: ocriplasmin
    Subjects were exposed to a single intravitreal injection of 125umg of ocriplasmin in a previous phase III studies TG-MV-006 and 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • N/A
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT01287988     History of Changes
Other Study ID Numbers: TG-MV-012
Study First Received: January 24, 2011
Last Updated: March 5, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013