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

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
Vitreomacular Adhesion	Drug: Ocriplasmin 125µg Drug: Placebo	Phase 3

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: Ocriplasmin

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

Secondary Outcome Measures:

Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
Proportion of subjects with total PVD at Day 28, as determined by masked investigator assessment of B-scan ultrasound.

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: Ocriplasmin 125µg 125µg of ocriplasmin intravitreal injection	Drug: Ocriplasmin 125µg 125µg of ocriplasmin intravitreal injection Other Name: Microplasmin
Placebo Comparator: Placebo Intravitreal injection of placebo	Drug: Placebo Intravitreal injection placebo.

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 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).

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 by ThromboGenics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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. Print 2012 Sep.

Responsible Party:	ThromboGenics
ClinicalTrials.gov Identifier:	NCT00798317 History of Changes
Other Study ID Numbers:	TG-MV-007
Study First Received:	November 25, 2008
Results First Received:	December 20, 2012
Last Updated:	January 30, 2013
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines Czech Republic: State Institute for Drug Control France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) 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 May 16, 2013