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

ThromboGenics

Status: Completed

Conditions: Symptomatic Vitreomacular Adhesion

Treatments: Drug: ocriplasmin; Drug: placebo

Study type: Observational

Funder types: Industry

Identifiers

NCT01287988

TG-MV-012

Details and patient eligibility

About

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).

Full description

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

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

24 participants in 2 patient groups

Ocriplasmin

Description:

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)

Treatment:

Drug: ocriplasmin

Placebo

Description:

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

Treatment:

Drug: placebo