Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-006) Trial.
- Registration Number
- NCT00781859
- Lead Sponsor
- ThromboGenics
- Brief Summary
The objective of this trial is to evaluate the safety and efficacy of intravitreal microplasmin 125µg dose in subjects wiht focal vitreomacular adhesion.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 326
- 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)
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 125µg Ocriplasmin 125 µg Ocriplasmin 125µg intravitreal injection of ocriplasmin Placebo Placebo placebo intravitreal injection
- Primary Outcome Measures
Name Time Method Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28. 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.
- Secondary Outcome Measures
Name Time Method Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28 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.
Trial Locations
- Locations (41)
Retina Vitreous Associate Medical Group
🇺🇸Beverly Hills, California, United States
VMR Institute
🇺🇸Huntington Beach, California, United States
Southern California Desert Retina Consultants
🇺🇸Palm Springs, California, United States
Retina Centers, P.C.
🇺🇸Tucson, Arizona, United States
National Ophthalmologic Research Institute
🇺🇸Ft. Meyers, Florida, United States
Rocky Mountain Lions Eye Institute
🇺🇸Aurora, Colorado, United States
Retinal Consultants Medical Group
🇺🇸Sacramento, California, United States
Southeast Retina Center, PC
🇺🇸Augusta, Georgia, United States
Midwest Eye Institute
🇺🇸Indianapolis,, Indiana, United States
Rush University Med. Ctr
🇺🇸Chicago,, Illinois, United States
Sarasota Retina Institute
🇺🇸Sarasota, Florida, United States
National Retina Institute
🇺🇸Towson, Maryland, United States
Retina Vitreous Centre, PA
🇺🇸New Brunswick, New Jersey, United States
Souteastern Retina Associates
🇺🇸Kingsport, Tennessee, United States
Allegheny Ophthalmic & Orbital Associates, PC
🇺🇸Pittsburgh, Pennsylvania, United States
Retinal Consultants of AZ
🇺🇸Phoenix, Arizona, United States
Assocaited Retina Consultants, Ltd.
🇺🇸Phoenix, Arizona, United States
Colorado Retina Associates, PC
🇺🇸Denver, Colorado, United States
Kresge Eye Institute
🇺🇸Detroit, Michigan, United States
Vitroretinal Surgery PA
🇺🇸Minneapolis, Minnesota, United States
Duke Eye Center
🇺🇸Durham, North Carolina, United States
Retinal Consultants of San Antonio
🇺🇸San Antonio, Texas, United States
Vitroretinal Consultants
🇺🇸Houston, Texas, 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
University of Miami-Bascom Palmer Eye Institute- Palm Beach
🇺🇸Palm Beach, Florida, United States
Maine Vitreoretinal Consultants, LLC, PA
🇺🇸Bangor, Maine, United States
New York Eye and Ear Infirmary
🇺🇸New York, New York, United States
University of Michigan-Kellogg Eye Center
🇺🇸Ann Arbor, Michigan, United States
Center for Retina and Macular Disease
🇺🇸Winter Haven, Florida, United States
Columbia University - Harkness Eye Institute
🇺🇸New York, New York, United States
Retina Vitreous Surgeons of Central NY
🇺🇸New York, New York, United States
Associated Retina Consultants
🇺🇸Royal Oak,, Michigan, United States
Wake Forest University Eye Center
🇺🇸Winston-Salem, North Carolina, United States
Valley Retina Institute, P.A.
🇺🇸McAllen, Texas, United States
Austin Retina Associates
🇺🇸Austin, Texas, United States
Pennsylvania Retina Specialists, P.C.
🇺🇸Camp Hill, Pennsylvania, United States
Retina Association of Cleveland
🇺🇸Lakewood, Ohio, United States
Vitreo-Retinal Associates
🇺🇸Grand Rapids, Michigan, United States
Retina Association of NJ
🇺🇸Teaneck, New Jersey, United States
Caroline Eye Associates
🇺🇸Southern Pines, North Carolina, United States