NCT01287988

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2011

Shorter than P25 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 2, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

January 13, 2017

Status Verified

April 1, 2014

Enrollment Period

5 months

First QC Date

January 24, 2011

Last Update Submit

January 12, 2017

Conditions

Symptomatic Vitreomacular Adhesion

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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)

Drug: 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)

Drug: placebo

Interventions

ocriplasminDRUG

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

Ocriplasmin
placeboDRUG

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have previously participated in either of the ocriplasmin Phase III studies (TG-MV-006 or TG-MV-007)

You may qualify if:

  • Previous participation in either of the placebo controlled, ocriplasmin Phase III studies (TG-MV-006 or TG-MV-007)

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Retinal Consultants of Houston

Houston, Texas, United States

Location

Universitaire Ziekenhuizen K.U. Leuven

Leuven, Belgium

Location

MeSH Terms

Interventions

microplasmin

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2011

First Posted

February 2, 2011

Study Start

May 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

January 13, 2017

Record last verified: 2014-04

Locations

US(1)BE(1)