Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-006) Trial.

This study is currently recruiting participants.

Verified by ThromboGenics, July 2009

First Received: October 28, 2008 Last Updated: July 6, 2009 History of Changes

Sponsored by:	ThromboGenics
Information provided by:	ThromboGenics
ClinicalTrials.gov Identifier:	NCT00781859

Purpose

The objective of this trial is to evaluate the safety and efficacy of intravitreal microplasmin 125ug dose in subjects wiht focal vitreomacular adhesion.

Condition	Intervention	Phase
Vitreomacular Traction	Drug: microplasmin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Placebo Controlled, Double-Masked, Multicenter Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion

Resource links provided by NLM:

MedlinePlus related topics: Adhesions

Drug Information available for: Microplasmin

U.S. FDA Resources

Further study details as provided by ThromboGenics:

Primary Outcome Measures:

Portion of subjects with nonsurgical resolution of focal vitreomacular adhesion at day 28. [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Total PVD [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

Estimated Enrollment:	320
Study Start Date:	December 2008
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: microplasmin 125 ug microplasmin intravitreal injection or placebo injection.
2: Placebo Comparator	Drug: microplasmin 125 ug microplasmin intravitreal injection or placebo injection.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with symptomatic focal vitreomacular adhesion are eligible for the study.

Exclusion Criteria:

Subjects with ocular abnormalities or prior treatments that would potentially interfere with the evaluation of safety and efficacy of study drug are excluded from participation.
Subjects who are pregnant or of child-bearing potential not utilizing an acceptable form of contraception.

Acceptable methods of birth control include intrauterine device, oral, implanted, or injected contraceptives, and barrier methods with spermicide.

Subjects who, in the investigators view, will not complete all visits and investigations.
Subjects who have participated in an investigational drug trial within the past 30 days.
Subjects who have previously participated in this trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781859

Contacts

Contact: Donna Bezner

212-201-0920

donna.bezner@thrombogenics.com

Show 42 Study Locations

Sponsors and Collaborators

ThromboGenics

More Information

No publications provided

Responsible Party:	ThromboGenics ( Donna Bezner )
Study ID Numbers:	TG-MV-006
Study First Received:	October 28, 2008
Last Updated:	July 6, 2009
ClinicalTrials.gov Identifier:	NCT00781859 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by ThromboGenics:

Focal vitreomacular adhesion

Study placed in the following topic categories:

Adhesions

Additional relevant MeSH terms:

Pathologic Processes
Adhesions

ClinicalTrials.gov processed this record on September 01, 2009