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).
|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.|
- 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.
|Study Start Date:||May 2011|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Non-interventional follow up study consisting of 1 patient visit to perform assessments to assess long term visual function
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287988
|United States, Texas|
|Retinal Consultants of Houston|
|Houston, Texas, United States|
|Universitaire Ziekenhuizen K.U. Leuven|