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

Symptomatic Vitreomacular Adhesion Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01287988
• Other study ID #: TG-MV-012
• Status: Completed
• Phase: N/A
• First received: January 24, 2011
• Last updated: January 12, 2017
• Start date: May 2011
• Est. completion date: October 2011

Study information

• Verified date: April 2014
• Source: ThromboGenics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Symptomatic Vitreomacular Adhesion

Intervention

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

Locations

Country	Name	City	State
Belgium	Universitaire Ziekenhuizen K.U. Leuven	Leuven
United States	Retinal Consultants of Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
ThromboGenics

Countries where clinical trial is conducted

United States,  Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Visit 1