Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-007) 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.

This trial will evaluate the safety and efficacy of microplasmin, administered as an intravitreal injection, in subjects with focal vitreomacular adhesion. In previously performed clinical trials, some patients treated with intravitreal microplasmin have had resolution of their underlying condition, including macular hole closure, without need for vitrectomy. This clinical trial is justified because the sponsor believes the potential benefits outweigh the potential risks.

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

  • Belgium
      • Leuven, Belgium
        • University Hospital Leuven
  • Czech Republic
      • Brno, Czech Republic, 625 00
        • University Hospital Brno
      • Hradec Kralove, Czech Republic, 500 05
        • University Hospital Hradec Kralove
      • Olomouc, Czech Republic, 775 20
        • University Hospital Olomouc
      • Prague, Czech Republic, 100 34
        • University Hospital Kralovske Vinohrady
      • Prague, Czech Republic, 169 02
        • Central Military Hospital
      • Zlin, Czech Republic, 760 01
        • Gemini Eye Clinic
  • Germany
      • Bonn, Germany, D-53127
        • Augenklinik-Universität Bonn
      • Bremen, Germany, 28209
        • St. Joseph Stift Bremen Abteilung für Augenheilkunde
      • Frankfurt, Germany, 60590
        • Universitäts-Augenklinik Frankfurt am Main
      • Frankfurt am Main, Germany, 65929
        • Städtische Kliniken Frankfurt am Main, Klinik für Augenheilkunde
      • Göttingen, Germany, 37075
        • Universität Göttingen
      • Leipzig, Germany, 04103
        • Klinik und Poliklinik für Augenheilkunde
      • Marburg, Germany, 35037
        • Philipps Universität Marburg
      • München, Germany, 80336
        • Augenklinik der Ludwig Maximilians Universität München
      • Münster, Germany, 48145
        • Augenarzte am St. Franziskus Hospital
      • Neubrandenburg, Germany, 17036
        • Augenklinik im Dietrich-
  • Poland
      • Gdansk, Poland, 80-147
        • Indywidualna Specjalistyczna Praktyka Prywatna
      • Katowice, Poland, 40-760
        • Oddział Okulistyczny OSK,
  • Spain
      • Alicante, Spain, 03016
        • Instituto Oftalmología de Alicante (Vissum)
      • Barcelona, Spain, 08022
        • Centro Teknon-Institut de la Macula i de la Retina
      • Madrid, Spain, 28046
        • Hospital La Paz
      • Santiago de Compostela, Spain, 15705
        • Instituto Technologico de Oftalmologia S.L
      • Valencia, Spain, 46014
        • Hospital General de Valencia
  • United Kingdom
      • Liverpool, United Kingdom, L7 8XP
        • St Paul's Eye Unit
      • London, United Kingdom, EC1V 2PD
        • Moorfields Eye Hospital
      • Southampton, United Kingdom, SO16 6YD
        • Southampton Eye Unit, Southampton General Hospital
      • Wolverhampton, United Kingdom, WV10 0QP
        • Wolverhampton Eye Infirmary-New Cross Hospital
  • United States
    • California
      • Campbell, California, United States, 95008
        • Retinal Diagnostic Center
      • San Francisco, California, United States, 94107
        • West Coast Retina Group, Inc
      • Santa Barbara, California, United States, 93103
        • California Retina Consultants
    • Florida
      • Miami, Florida, United States, 33143
        • Medeye
      • Pensacola, Florida, United States, 32503
        • Retina Specialists
    • Kentucky
      • Paducah, Kentucky, United States, 42001
        • Paducah Retinal Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Vision Research Center at Truman Medical Center
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Deleware Valley Retina Associates
    • New York
      • Albany, New York, United States, 12206
        • Capital Region Retina
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Southeast Clinical Research Assoicates, PA
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Dean A McGee Eye Institute
    • Pennsylvania
      • Philadelphia,, Pennsylvania, United States, 19104
        • Scheie Eye Institute, Penn Eye Care
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hils regional Eye Institute
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Retina Associates
      • Austin, Texas, United States, 78705
        • Retina Research Center
      • Fort Worth,, Texas, United States, 76104
        • Retina Consultants
      • San Antonio, Texas, United States, 78240
        • Medical Center Ophthalmology Assoc.
      • Tyler, Texas, United States, 75701
        • Eye Care Associates
    • Washington
      • Seattle, Washington, United States, 98104
        • VitreoRetinal Associates

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 6 mm 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: Ocriplasmin 125µg
125µg of ocriplasmin intravitreal injection
Drug: Ocriplasmin 125µg
125µg of ocriplasmin intravitreal injection
Other Names:
  • Microplasmin
Placebo Comparator: Placebo
Intravitreal injection of placebo
Drug: Placebo
Intravitreal injection placebo.

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
Proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at Day 28, as determined by masked Central Reading Centre (CRC) Optical Coherence Tomography(OCT)evaluation.
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
Proportion of subjects with total 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)

June 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

November 25, 2008

First Submitted That Met QC Criteria

November 25, 2008

First Posted (Estimate)

November 26, 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-007

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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