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

ThromboGenics

Status and phase

Completed

Phase 3

Conditions

Vitreomacular Adhesion

Treatments

Drug: Placebo

Drug: 125 µg Ocriplasmin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00781859

TG-MV-006

Details and patient eligibility

About

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

Enrollment

326 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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)

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).