Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-006) Trial.
NCT ID: NCT00781859
Last Updated: 2014-12-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
326 participants
INTERVENTIONAL
2008-12-31
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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125µg Ocriplasmin
125µg intravitreal injection of ocriplasmin
125 µg Ocriplasmin
125µg ocriplasmin intravitreal injection
Placebo
placebo intravitreal injection
Placebo
Placebo intravitreal injection
Interventions
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125 µg Ocriplasmin
125µg ocriplasmin intravitreal injection
Placebo
Placebo intravitreal injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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ThromboGenics
INDUSTRY
Responsible Party
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Locations
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Retinal Consultants of AZ
Phoenix, Arizona, United States
Assocaited Retina Consultants, Ltd.
Phoenix, Arizona, United States
Retina Centers, P.C.
Tucson, Arizona, United States
Retina Vitreous Associate Medical Group
Beverly Hills, California, United States
VMR Institute
Huntington Beach, California, United States
Jules Stein Eye Institute/UCLA
Los Angeles, California, United States
Southern California Desert Retina Consultants
Palm Springs, California, United States
Retinal Consultants Medical Group
Sacramento, California, United States
Rocky Mountain Lions Eye Institute
Aurora, Colorado, United States
Colorado Retina Associates, PC
Denver, Colorado, United States
National Ophthalmologic Research Institute
Fort Meyers, Florida, United States
University of Miami-Bascom Palmer Eye Institute- Palm Beach
Palm Beach, Florida, United States
Sarasota Retina Institute
Sarasota, Florida, United States
Center for Retina and Macular Disease
Winter Haven, Florida, United States
Southeast Retina Center, PC
Augusta, Georgia, United States
Rush University Med. Ctr
Chicago, Illinois, United States
Midwest Eye Institute
Indianapolis, Indiana, United States
Univ. Of Kentuck/Kentucky-Clinic/Dept of Ophthal & VS
Lexington, Kentucky, United States
Maine Vitreoretinal Consultants, LLC, PA
Bangor, Maine, United States
National Retina Institute
Towson, Maryland, United States
University of Michigan-Kellogg Eye Center
Ann Arbor, Michigan, United States
Kresge Eye Institute
Detroit, Michigan, United States
Vitreo-Retinal Associates
Grand Rapids, Michigan, United States
Associated Retina Consultants
Royal Oak, Michigan, United States
Vitroretinal Surgery PA
Minneapolis, Minnesota, United States
Retina Vitreous Centre, PA
New Brunswick, New Jersey, United States
Retina Association of NJ
Teaneck, New Jersey, United States
New York Eye and Ear Infirmary
New York, New York, United States
Columbia University - Harkness Eye Institute
New York, New York, United States
Retina Vitreous Surgeons of Central NY
New York, New York, United States
Duke Eye Center
Durham, North Carolina, United States
Caroline Eye Associates
Southern Pines, North Carolina, United States
Wake Forest University Eye Center
Winston-Salem, North Carolina, United States
Retina Association of Cleveland
Lakewood, Ohio, United States
Pennsylvania Retina Specialists, P.C.
Camp Hill, Pennsylvania, United States
Allegheny Ophthalmic & Orbital Associates, PC
Pittsburgh, Pennsylvania, United States
Souteastern Retina Associates
Kingsport, Tennessee, United States
Austin Retina Associates
Austin, Texas, United States
Vitroretinal Consultants
Houston, Texas, United States
Valley Retina Institute, P.A.
McAllen, Texas, United States
Retinal Consultants of San Antonio
San Antonio, Texas, United States
Countries
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References
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Varma R, Haller JA, Kaiser PK. Improvement in Patient-Reported Visual Function After Ocriplasmin for Vitreomacular Adhesion: Results of the Microplasmin for Intravitreous Injection-Traction Release Without Surgical Treatment (MIVI-TRUST) Trials. JAMA Ophthalmol. 2015 Sep;133(9):997-1004. doi: 10.1001/jamaophthalmol.2015.1746.
Folgar FA, Toth CA, DeCroos FC, Girach A, Pakola S, Jaffe GJ. Assessment of retinal morphology with spectral and time domain OCT in the phase III trials of enzymatic vitreolysis. Invest Ophthalmol Vis Sci. 2012 Oct 25;53(11):7395-401. doi: 10.1167/iovs.12-10379.
Stalmans P, Benz MS, Gandorfer A, Kampik A, Girach A, Pakola S, Haller JA; MIVI-TRUST Study Group. Enzymatic vitreolysis with ocriplasmin for vitreomacular traction and macular holes. N Engl J Med. 2012 Aug 16;367(7):606-15. doi: 10.1056/NEJMoa1110823.
DeCroos FC, Toth CA, Folgar FA, Pakola S, Stinnett SS, Heydary CS, Burns R, Jaffe GJ. Characterization of vitreoretinal interface disorders using OCT in the interventional phase 3 trials of ocriplasmin. Invest Ophthalmol Vis Sci. 2012 Sep 21;53(10):6504-11. doi: 10.1167/iovs.12-10370.
Other Identifiers
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TG-MV-006
Identifier Type: -
Identifier Source: org_study_id