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NCT Number: NCT01287988

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

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).

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Key information

Conditions

Symptomatic Vitreomacular Adhesion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitaire Ziekenhuizen K.U. Leuven, Leuven, Belgium

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ocriplasmin

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

Drug

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

ThromboGenics

Industry

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 2, 2011
Registry last updated
Jan 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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