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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01287988

Enrollment

Registered

2011-02-02

Start date

2011-05-31

Completion date

2011-10-31

Last updated

2017-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic Vitreomacular Adhesion

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

Interventions

DRUGocriplasmin

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

DRUGplacebo

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

Study design

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Belgium, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026