Expired Study
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Los Angeles, California 90095


Purpose:

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


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.


Study is Available At:


Original ID:

TG-MV-006


NCT ID:

NCT00781859


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

A Randomized, Placebo Controlled, Double-masked, Multicenter Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

ThromboGenics


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

326


Enrollment Type:

Actual


Study Dates

Start Date:December 2008
Completion Date:April 2010
Completion Type:Actual
Primary Completion Date:March 2010
Primary Completion Type:Actual
Verification Date:July 2011
Last Changed Date:October 24, 2012
First Received Date:October 28, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Portion of subjects with nonsurgical resolution of focal vitreomacular adhesion at day 28.
Time Frame:Day 28
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Total PVD
Time Frame:Day 28
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:microplasmin
Description:125 ug microplasmin intravitreal injection or placebo injection.
Arm Name:1

Study Arms

Study Arm Type:Active Comparator
Arm Name:1
Study Arm Type:Placebo Comparator
Arm Name:2

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:ThromboGenics

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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