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

December 2, 2014 updated by: ThromboGenics

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

326

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Retinal Consultants of AZ
      • Phoenix, Arizona, United States, 85020
        • Assocaited Retina Consultants, Ltd.
      • Tucson, Arizona, United States, 85704
        • Retina Centers, P.C.
    • California
      • Beverly Hills, California, United States, 90211
        • Retina Vitreous Associate Medical Group
      • Huntington Beach, California, United States, 92647
        • VMR Institute
      • Los Angeles, California, United States, 90095
        • Jules Stein Eye Institute/UCLA
      • Palm Springs, California, United States, 92262
        • Southern California Desert Retina Consultants
      • Sacramento, California, United States, 95819
        • Retinal Consultants Medical Group
    • Colorado
      • Aurora, Colorado, United States, 80045-0510
        • Rocky Mountain Lions Eye Institute
      • Denver, Colorado, United States, 80230
        • Colorado Retina Associates, PC
    • Florida
      • Ft. Meyers, Florida, United States, 33912
        • National Ophthalmologic Research Institute
      • Palm Beach, Florida, United States, 33418
        • University of Miami-Bascom Palmer Eye Institute- Palm Beach
      • Sarasota, Florida, United States, 34239
        • Sarasota Retina Institute
      • Winter Haven, Florida, United States, 33880
        • Center for Retina and Macular Disease
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Southeast Retina Center, PC
    • Illinois
      • Chicago,, Illinois, United States, 60612
        • Rush University Med. Ctr
    • Indiana
      • Indianapolis,, Indiana, United States, 46290
        • Midwest Eye Institute
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0284
        • Univ. Of Kentuck/Kentucky-Clinic/Dept of Ophthal & VS
    • Maine
      • Bangor, Maine, United States, 04401
        • Maine Vitreoretinal Consultants, LLC, PA
    • Maryland
      • Towson, Maryland, United States, 21204
        • National Retina Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • University of Michigan-Kellogg Eye Center
      • Detroit, Michigan, United States, 48201-1423
        • Kresge Eye Institute
      • Grand Rapids, Michigan, United States, 49525
        • Vitreo-Retinal Associates
      • Royal Oak,, Michigan, United States, 48073
        • Associated Retina Consultants
    • Minnesota
      • Minneapolis, Minnesota, United States, 55435
        • Vitroretinal Surgery PA
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Retina Vitreous Centre, PA
      • Teaneck, New Jersey, United States, 07666
        • Retina Association of NJ
    • New York
      • New York, New York, United States, 10003
        • New York Eye and Ear Infirmary
      • New York, New York, United States, 10032
        • Columbia University - Harkness Eye Institute
      • New York, New York, United States, 13224
        • Retina Vitreous Surgeons of Central NY
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Eye Center
      • Southern Pines, North Carolina, United States, 28387
        • Caroline Eye Associates
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Eye Center
    • Ohio
      • Lakewood, Ohio, United States, 44107
        • Retina Association of Cleveland
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Pennsylvania Retina Specialists, P.C.
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Ophthalmic & Orbital Associates, PC
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Souteastern Retina Associates
    • Texas
      • Austin, Texas, United States, 78705
        • Austin Retina Associates
      • Houston, Texas, United States, 77030
        • Vitroretinal Consultants
      • McAllen, Texas, United States, 78503
        • Valley Retina Institute, P.A.
      • San Antonio, Texas, United States, 78240
        • Retinal Consultants of San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Presence of focal vitreomacular adhesion (i.e., central vitreal adhesion within 6mm Optical Coherence Tomography (OCT) field surrounded by elevation of the posterior vitreous cortex) that in the opinion of the Investigator is related to decreased visual function (such as metamorphopsia, decreased visual acuity, or other visual complaint)

Exclusion Criteria:

  • Any evidence of proliferative retinopathy (including Proliferative Diabetic Retinopathy (PDR) or other ischemic retinopathies involving vitreoretinal vascular proliferation) or exudative Age-Related Macular Degeneration (AMD) or retinal vein occlusion in the study eye.
  • Subjects with any vitreous hemorrhage or any other vitreous opacification which precludes either of the following: visualization of the posterior pole by visual inspection OR adequate assessment of the macula by either OCT and/or fluorescein angiogram in the study eye.
  • Subjects with macular hole diameter > 400 μm in the study eye.
  • Aphakia in the study eye.
  • High myopia (more than 8D) in study eye (unless prior cataract extraction or refractive surgery that makes refraction assessment unreliable for myopia severity approximation, in which case axial length >28 mm is an exclusion).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 125µg Ocriplasmin
125µg intravitreal injection of ocriplasmin
Drug: 125 µg Ocriplasmin
125µg ocriplasmin intravitreal injection
Other Names:
  • microplasmin
Placebo Comparator: Placebo
placebo intravitreal injection
Drug: Placebo
Placebo intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28.
Time Frame: Day 28
The primary efficacy endpoint was the proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at Day 28 post-injection, as determined by masked Central Reading Center (CRC) Optical Coherence Tomography (OCT) evaluation. Any subjects who had a creation of an anatomical defect (i.e. retinal hole, retinal detachment) that resulted in loss of vision or that required additional intervention were not counted as successes for this primary endpoint.
Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28
Time Frame: Day 28
The key secondary endpoint of this study was the proportion of subjects with total Posterior Vitreous Detachment (PVD) at Day 28, as determined by masked Investigator assessment of B-scan ultrasound.
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ThromboGenics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

October 28, 2008

First Submitted That Met QC Criteria

October 28, 2008

First Posted (Estimate)

October 29, 2008

Study Record Updates

Last Update Posted (Estimate)

December 17, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TG-MV-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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