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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00798317
Recruitment Status : Completed
First Posted : November 26, 2008
Results First Posted : January 30, 2013
Last Update Posted : December 17, 2014
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Vitreomacular Adhesion Drug: Ocriplasmin 125µg Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 326 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo Controlled, Double-masked, Multicenter Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion.
Study Start Date : December 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions
Drug Information available for: Ocriplasmin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ocriplasmin 125µg
125µg of ocriplasmin intravitreal injection
Drug: Ocriplasmin 125µg
125µg of ocriplasmin intravitreal injection
Other Name: Microplasmin
Placebo Comparator: Placebo
Intravitreal injection of placebo
Drug: Placebo
Intravitreal injection placebo.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00798317

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: ThromboGenics Identifier: NCT00798317     History of Changes
Other Study ID Numbers: TG-MV-007
First Posted: November 26, 2008    Key Record Dates
Results First Posted: January 30, 2013
Last Update Posted: December 17, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Tissue Adhesions
Pathologic Processes
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action