Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-007) Trial.
- Registration Number
- NCT00798317
- Lead Sponsor
- ThromboGenics
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 326
- 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)
- 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 Placebo Placebo Intravitreal injection of placebo Ocriplasmin 125µg Ocriplasmin 125µg 125µg of ocriplasmin intravitreal injection
- Primary Outcome Measures
Name Time Method Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28 Day 28 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
Name Time Method Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28 Day 28 Proportion of subjects with total PVD at Day 28, as determined by masked investigator assessment of B-scan ultrasound.
Trial Locations
- Locations (48)
Retina Specialists
🇺🇸Pensacola, Florida, United States
Black Hils regional Eye Institute
🇺🇸Rapid City, South Dakota, United States
Scheie Eye Institute, Penn Eye Care
🇺🇸Philadelphia,, Pennsylvania, United States
Dean A McGee Eye Institute
🇺🇸Oklahoma City, Oklahoma, United States
Medical Center Ophthalmology Assoc.
🇺🇸San Antonio, Texas, United States
St. Joseph Stift Bremen Abteilung für Augenheilkunde
🇩🇪Bremen, Germany
University Hospital Brno
🇨🇿Brno, Czech Republic
Oddział Okulistyczny OSK,
🇵🇱Katowice, Poland
Klinik und Poliklinik für Augenheilkunde
🇩🇪Leipzig, Germany
Hospital General de Valencia
🇪🇸Valencia, Spain
Vision Research Center at Truman Medical Center
🇺🇸Kansas City, Missouri, United States
California Retina Consultants
🇺🇸Santa Barbara, California, United States
Paducah Retinal Center
🇺🇸Paducah, Kentucky, United States
Philipps Universität Marburg
🇩🇪Marburg, Germany
Retina Consultants
🇺🇸Fort Worth,, Texas, United States
Augenklinik-Universität Bonn
🇩🇪Bonn, Germany
University Hospital Hradec Kralove
🇨🇿Hradec Kralove, Czech Republic
Central Military Hospital
🇨🇿Prague, Czech Republic
University Hospital Leuven
🇧🇪Leuven, Belgium
University Hospital Olomouc
🇨🇿Olomouc, Czech Republic
Centro Teknon-Institut de la Macula i de la Retina
🇪🇸Barcelona, Spain
University Hospital Kralovske Vinohrady
🇨🇿Prague, Czech Republic
Gemini Eye Clinic
🇨🇿Zlin, Czech Republic
Southampton Eye Unit, Southampton General Hospital
🇬🇧Southampton, United Kingdom
Städtische Kliniken Frankfurt am Main, Klinik für Augenheilkunde
🇩🇪Frankfurt am Main, Germany
Augenklinik der Ludwig Maximilians Universität München
🇩🇪München, Germany
Universitäts-Augenklinik Frankfurt am Main
🇩🇪Frankfurt, Germany
Texas Retina Associates
🇺🇸Arlington, Texas, United States
Universität Göttingen
🇩🇪Göttingen, Germany
Instituto Oftalmología de Alicante (Vissum)
🇪🇸Alicante, Spain
Instituto Technologico de Oftalmologia S.L
🇪🇸Santiago de Compostela, Spain
Indywidualna Specjalistyczna Praktyka Prywatna
🇵🇱Gdansk, Poland
St Paul's Eye Unit
🇬🇧Liverpool, United Kingdom
Wolverhampton Eye Infirmary-New Cross Hospital
🇬🇧Wolverhampton, United Kingdom
Augenklinik im Dietrich-
🇩🇪Neubrandenburg, Germany
Retinal Diagnostic Center
🇺🇸Campbell, California, United States
West Coast Retina Group, Inc
🇺🇸San Francisco, California, United States
Medeye
🇺🇸Miami, Florida, United States
Hospital La Paz
🇪🇸Madrid, Spain
Capital Region Retina
🇺🇸Albany, New York, United States
Eye Care Associates
🇺🇸Tyler, Texas, United States
Retina Research Center
🇺🇸Austin, Texas, United States
Vitreoretinal Associates
🇺🇸Seattle, Washington, United States
Augenärzte am St. Franziskus Hospital
🇩🇪Münster, Germany
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Southeast Clinical Research Assoicates, PA
🇺🇸Charlotte, North Carolina, United States
Deleware Valley Retina Associates
🇺🇸Lawrenceville, New Jersey, United States
Moorfields Eye Hospital
🇬🇧London, United Kingdom