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

Completed · Phase 3 · Has a placebo group

Conditions studied: Vitreomacular Adhesion

In brief

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.

Key facts

Study ID

NCT00798317

Run by

ThromboGenics

People needed

326

Starts

2008-12-01

Expected to finish

2010-07-01

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 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)

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 Diagnostic Center — Campbell, California, United States
• West Coast Retina Group, Inc — San Francisco, California, United States
• California Retina Consultants — Santa Barbara, California, United States
• Medeye — Miami, Florida, United States
• Retina Specialists — Pensacola, Florida, United States
• Paducah Retinal Center — Paducah, Kentucky, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Vision Research Center at Truman Medical Center — Kansas City, Missouri, United States
• Deleware Valley Retina Associates — Lawrenceville, New Jersey, United States
• Capital Region Retina — Albany, New York, United States
• Southeast Clinical Research Assoicates, PA — Charlotte, North Carolina, United States
• Dean A McGee Eye Institute — Oklahoma City, Oklahoma, United States
• Scheie Eye Institute, Penn Eye Care — Philadelphia, Pennsylvania, United States
• Black Hils regional Eye Institute — Rapid City, South Dakota, United States
• Texas Retina Associates — Arlington, Texas, United States
• Retina Research Center — Austin, Texas, United States
• Retina Consultants — Fort Worth, Texas, United States
• Medical Center Ophthalmology Assoc. — San Antonio, Texas, United States
• Eye Care Associates — Tyler, Texas, United States
• Vitreoretinal Associates — Seattle, Washington, United States
• University Hospital Leuven — Leuven, Belgium
• University Hospital Brno — Brno, Czechia
• University Hospital Hradec Kralove — Hradec Králové, Czechia
• University Hospital Olomouc — Olomouc, Czechia
• University Hospital Kralovske Vinohrady — Prague, Czechia

Full record on ClinicalTrials.gov

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