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

Completed · Phase 3 · Has a placebo group

Conditions studied: Vitreomacular Adhesion

In brief

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

Key facts

Study ID

NCT00781859

Run by

ThromboGenics

People needed

326

Starts

2008-12-01

Expected to finish

2010-04-01

Last updated by the study team

2014-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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