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

Vitreomacular Adhesion Clinical Trial

Official title:

A Randomized, Placebo Controlled, Double-masked, Multicenter Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00781859
• Other study ID #: TG-MV-006
• Status: Completed
• Phase: Phase 3
• First received: October 28, 2008
• Last updated: December 2, 2014
• Start date: December 2008
• Est. completion date: April 2010

Study information

• Verified date: April 2014
• Source: ThromboGenics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tissue Adhesions
• Vitreomacular Adhesion

Intervention

Drug:
• 125 µg Ocriplasmin
125µg ocriplasmin intravitreal injection
• Placebo
Placebo intravitreal injection

Locations

Country	Name	City	State
United States	University of Michigan-Kellogg Eye Center	Ann Arbor	Michigan
United States	Southeast Retina Center, PC	Augusta	Georgia
United States	Rocky Mountain Lions Eye Institute	Aurora	Colorado
United States	Austin Retina Associates	Austin	Texas
United States	Maine Vitreoretinal Consultants, LLC, PA	Bangor	Maine
United States	Retina Vitreous Associate Medical Group	Beverly Hills	California
United States	Pennsylvania Retina Specialists, P.C.	Camp Hill	Pennsylvania
United States	Rush University Med. Ctr	Chicago,	Illinois
United States	Colorado Retina Associates, PC	Denver	Colorado
United States	Kresge Eye Institute	Detroit	Michigan
United States	Duke Eye Center	Durham	North Carolina
United States	National Ophthalmologic Research Institute	Ft. Meyers	Florida
United States	Vitreo-Retinal Associates	Grand Rapids	Michigan
United States	Vitroretinal Consultants	Houston	Texas
United States	VMR Institute	Huntington Beach	California
United States	Midwest Eye Institute	Indianapolis,	Indiana
United States	Souteastern Retina Associates	Kingsport	Tennessee
United States	Retina Association of Cleveland	Lakewood	Ohio
United States	Univ. Of Kentuck/Kentucky-Clinic/Dept of Ophthal & VS	Lexington	Kentucky
United States	Jules Stein Eye Institute/UCLA	Los Angeles	California
United States	Valley Retina Institute, P.A.	McAllen	Texas
United States	Vitroretinal Surgery PA	Minneapolis	Minnesota
United States	Retina Vitreous Centre, PA	New Brunswick	New Jersey
United States	Columbia University - Harkness Eye Institute	New York	New York
United States	New York Eye and Ear Infirmary	New York	New York
United States	Retina Vitreous Surgeons of Central NY	New York	New York
United States	University of Miami-Bascom Palmer Eye Institute- Palm Beach	Palm Beach	Florida
United States	Southern California Desert Retina Consultants	Palm Springs	California
United States	Assocaited Retina Consultants, Ltd.	Phoenix	Arizona
United States	Retinal Consultants of AZ	Phoenix	Arizona
United States	Allegheny Ophthalmic & Orbital Associates, PC	Pittsburgh	Pennsylvania
United States	Associated Retina Consultants	Royal Oak,	Michigan
United States	Retinal Consultants Medical Group	Sacramento	California
United States	Retinal Consultants of San Antonio	San Antonio	Texas
United States	Sarasota Retina Institute	Sarasota	Florida
United States	Caroline Eye Associates	Southern Pines	North Carolina
United States	Retina Association of NJ	Teaneck	New Jersey
United States	National Retina Institute	Towson	Maryland
United States	Retina Centers, P.C.	Tucson	Arizona
United States	Wake Forest University Eye Center	Winston-Salem	North Carolina
United States	Center for Retina and Macular Disease	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
ThromboGenics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28.	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.	Day 28	No
Secondary	Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28	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.	Day 28	No