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

Purpose

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

Condition	Intervention	Phase
Vitreomacular Adhesion	Drug: 125 µg Ocriplasmin 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 ]
The primary efficacy endpoint was the proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at Day 28 post-injection, as determined by masked Central Reading Center (CRC) Optical Coherence Tomography (OCT) evaluation. Any subjects who had a creation of an anatomical defect (i.e. retinal hole, retinal detachment) that resulted in loss of vision or that required additional intervention were not counted as successes for this primary endpoint.

Secondary Outcome Measures:

Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
The key secondary endpoint of this study was the proportion of subjects with total Posterior Vitreous Detachment (PVD) at Day 28, as determined by masked Investigator assessment of B-scan ultrasound.


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

Arms	Assigned Interventions
Experimental: 125µg Ocriplasmin 125µg intravitreal injection of ocriplasmin	Drug: 125 µg Ocriplasmin 125µg ocriplasmin intravitreal injection Other Name: microplasmin
Placebo Comparator: Placebo placebo intravitreal injection	Drug: Placebo Placebo intravitreal injection

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 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).

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00781859

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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. doi: 10.1056/NEJMoa1110823.

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.


Responsible Party:	ThromboGenics
ClinicalTrials.gov Identifier:	NCT00781859 History of Changes
Other Study ID Numbers:	TG-MV-006
Study First Received:	October 28, 2008
Results First Received:	December 20, 2012
Last Updated:	December 2, 2014
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on February 27, 2015