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.
Overview
- Phase
- Not Applicable
- Intervention
- ocriplasmin
- Conditions
- Symptomatic Vitreomacular Adhesion
- Sponsor
- ThromboGenics
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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).
Detailed Description
Non-interventional follow up study consisting of 1 patient visit to perform assessments to assess long term visual function
Investigators
Eligibility 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
- Not provided
Arms & 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)
Intervention: ocriplasmin
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)
Intervention: placebo
Outcomes
Primary Outcomes
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.