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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ThromboGenics
ClinicalTrials.gov Identifier:
NCT00781859
First received: October 28, 2008
Last updated: April 4, 2014
Last verified: April 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Arizona
Retinal Consultants of AZ
Phoenix, Arizona, United States, 85014
Assocaited Retina Consultants, Ltd.
Phoenix, Arizona, United States, 85020
Retina Centers, P.C.
Tucson, Arizona, United States, 85704
United States, California
Retina Vitreous Associate Medical Group
Beverly Hills, California, United States, 90211
VMR Institute
Huntington Beach, California, United States, 92647
Jules Stein Eye Institute/UCLA
Los Angeles, California, United States, 90095
Southern California Desert Retina Consultants
Palm Springs, California, United States, 92262
Retinal Consultants Medical Group
Sacramento, California, United States, 95819
United States, Colorado
Rocky Mountain Lions Eye Institute
Aurora, Colorado, United States, 80045-0510
Colorado Retina Associates, PC
Denver, Colorado, United States, 80230
United States, Florida
National Ophthalmologic Research Institute
Ft. Meyers, Florida, United States, 33912
University of Miami-Bascom Palmer Eye Institute- Palm Beach
Palm Beach, Florida, United States, 33418
Sarasota Retina Institute
Sarasota, Florida, United States, 34239
Center for Retina and Macular Disease
Winter Haven, Florida, United States, 33880
United States, Georgia
Southeast Retina Center, PC
Augusta, Georgia, United States, 30909
United States, Illinois
Rush University Med. Ctr
Chicago,, Illinois, United States, 60612
United States, Indiana
Midwest Eye Institute
Indianapolis,, Indiana, United States, 46290
United States, Kentucky
Univ. Of Kentuck/Kentucky-Clinic/Dept of Ophthal & VS
Lexington, Kentucky, United States, 40536-0284
United States, Maine
Maine Vitreoretinal Consultants, LLC, PA
Bangor, Maine, United States, 04401
United States, Maryland
National Retina Institute
Towson, Maryland, United States, 21204
United States, Michigan
University of Michigan-Kellogg Eye Center
Ann Arbor, Michigan, United States, 48105
Kresge Eye Institute
Detroit, Michigan, United States, 48201-1423
Vitreo-Retinal Associates
Grand Rapids, Michigan, United States, 49525
Associated Retina Consultants
Royal Oak,, Michigan, United States, 48073
United States, Minnesota
Vitroretinal Surgery PA
Minneapolis, Minnesota, United States, 55435
United States, New Jersey
Retina Vitreous Centre, PA
New Brunswick, New Jersey, United States, 08901
Retina Association of NJ
Teaneck, New Jersey, United States, 07666
United States, New York
Retina Vitreous Surgeons of Central NY
New York, New York, United States, 13224
Columbia University - Harkness Eye Institute
New York, New York, United States, 10032
New York Eye and Ear Infirmary
New York, New York, United States, 10003
United States, North Carolina
Duke Eye Center
Durham, North Carolina, United States, 27710
Caroline Eye Associates
Southern Pines, North Carolina, United States, 28387
Wake Forest University Eye Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Retina Association of Cleveland
Lakewood, Ohio, United States, 44107
United States, Pennsylvania
Pennsylvania Retina Specialists, P.C.
Camp Hill, Pennsylvania, United States, 17011
Allegheny Ophthalmic & Orbital Associates, PC
Pittsburgh, Pennsylvania, United States, 15212
United States, Tennessee
Souteastern Retina Associates
Kingsport, Tennessee, United States, 37660
United States, Texas
Austin Retina Associates
Austin, Texas, United States, 78705
Vitroretinal Consultants
Houston, Texas, United States, 77030
Valley Retina Institute, P.A.
McAllen, Texas, United States, 78503
Retinal Consultants of San Antonio
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
ThromboGenics
  More Information

No publications provided by ThromboGenics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: April 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014