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

Completed

• Conditions: Symptomatic Vitreomacular Adhesion
• Interventions: Drug: placebo; Drug: ocriplasmin

• Registration Number: NCT01287988
• Lead Sponsor: 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).

Detailed Description

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

Study Timeline

• Study First Submitted: 2011-01-24
• Study First Submitted QC: 2011-02-01
• Study First Posted: 2011-02-02
• Study Start: 2011-05
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2014-04
• Last Update Submitted: 2017-01-12
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Placebo	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)
Ocriplasmin	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)

Primary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (2)

Universitaire Ziekenhuizen K.U. Leuven; 🇧🇪 Leuven, Belgium

Retinal Consultants of Houston; 🇺🇸 Houston, Texas, United States