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

Sponsor:	ThromboGenics
Information provided by (Responsible Party):	ThromboGenics
ClinicalTrials.gov Identifier:	NCT00798317

Purpose

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	Intervention	Phase
Symptomatic Vitreomacular Adhesion	Drug: Microplasmin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

MedlinePlus related topics: Adhesions

Drug Information available for: Microplasmin

U.S. FDA Resources

Further study details as provided by ThromboGenics:

Primary Outcome Measures:

Proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at day 28, as determined by masked Central Reading Centre (CRC) OCT evaluation. [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects with total PVD at day 28, as determined by masked investigator assessment of B-scan ultrasound. [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

Enrollment:	326
Study Start Date:	December 2008
Study Completion Date:	July 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Microplasmin Intravitreal injection of 0.1 ml microplasmin solution containing 125ug of microplasmin.
Placebo Comparator: 2	Drug: Microplasmin Intravitreal injection of 0.1 ml placebo solution.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Presence of focal vitreomacular adhesion (i.e., central vitreal adhesion within 6 mm 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 PDR or other ischemic retinopathies involving vitreoretinal vascular proliferation) or exudative 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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798317

Show 48 Study Locations

Sponsors and Collaborators

ThromboGenics

More Information

No publications provided

Responsible Party:	ThromboGenics
ClinicalTrials.gov Identifier:	NCT00798317 History of Changes
Other Study ID Numbers:	TG-MV-007
Study First Received:	November 25, 2008
Last Updated:	November 7, 2011
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines; Czech Republic: State Institute for Drug Control; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Poland: Ministry of Health; Portugal: National Pharmacy and Medicines Institute; Spain: Spanish Agency of Medicines; United States: Food and Drug Administration

Additional relevant MeSH terms:

Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012