Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-007) Trial.
A Randomized, Placebo Controlled, Double-masked, Multicenter Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion.
1 other identifier
interventional
326
7 countries
48
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2008
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2008
CompletedFirst Posted
Study publicly available on registry
November 26, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedResults Posted
Study results publicly available
January 30, 2013
CompletedDecember 17, 2014
April 1, 2014
1.5 years
November 25, 2008
December 20, 2012
December 2, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at 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.
Day 28
Secondary Outcomes (1)
Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28
Day 28
Study Arms (2)
Ocriplasmin 125µg
EXPERIMENTAL125µg of ocriplasmin intravitreal injection
Placebo
PLACEBO COMPARATORIntravitreal injection of placebo
Interventions
125µg of ocriplasmin intravitreal injection
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ThromboGenicslead
Study Sites (48)
Retinal Diagnostic Center
Campbell, California, 95008, United States
West Coast Retina Group, Inc
San Francisco, California, 94107, United States
California Retina Consultants
Santa Barbara, California, 93103, United States
Medeye
Miami, Florida, 33143, United States
Retina Specialists
Pensacola, Florida, 32503, United States
Paducah Retinal Center
Paducah, Kentucky, 42001, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Vision Research Center at Truman Medical Center
Kansas City, Missouri, 64108, United States
Deleware Valley Retina Associates
Lawrenceville, New Jersey, 08648, United States
Capital Region Retina
Albany, New York, 12206, United States
Southeast Clinical Research Assoicates, PA
Charlotte, North Carolina, 28210, United States
Dean A McGee Eye Institute
Oklahoma City, Oklahoma, 73104, United States
Scheie Eye Institute, Penn Eye Care
Philadelphia, Pennsylvania, 19104, United States
Black Hils regional Eye Institute
Rapid City, South Dakota, 57701, United States
Texas Retina Associates
Arlington, Texas, 76012, United States
Retina Research Center
Austin, Texas, 78705, United States
Retina Consultants
Fort Worth, Texas, 76104, United States
Medical Center Ophthalmology Assoc.
San Antonio, Texas, 78240, United States
Eye Care Associates
Tyler, Texas, 75701, United States
Vitreoretinal Associates
Seattle, Washington, 98104, United States
University Hospital Leuven
Leuven, Belgium
University Hospital Brno
Brno, 625 00, Czechia
University Hospital Hradec Kralove
Hradec Králové, 500 05, Czechia
University Hospital Olomouc
Olomouc, 775 20, Czechia
University Hospital Kralovske Vinohrady
Prague, 100 34, Czechia
Central Military Hospital
Prague, 169 02, Czechia
Gemini Eye Clinic
Zlín, 760 01, Czechia
Augenklinik-Universität Bonn
Bonn, D-53127, Germany
St. Joseph Stift Bremen Abteilung für Augenheilkunde
Bremen, 28209, Germany
Universitäts-Augenklinik Frankfurt am Main
Frankfurt, 60590, Germany
Städtische Kliniken Frankfurt am Main, Klinik für Augenheilkunde
Frankfurt am Main, 65929, Germany
Universität Göttingen
Göttingen, 37075, Germany
Klinik und Poliklinik für Augenheilkunde
Leipzig, 04103, Germany
Philipps Universität Marburg
Marburg, 35037, Germany
Augenklinik der Ludwig Maximilians Universität München
München, 80336, Germany
Augenärzte am St. Franziskus Hospital
Münster, 48145, Germany
Augenklinik im Dietrich-
Neubrandenburg, 17036, Germany
Indywidualna Specjalistyczna Praktyka Prywatna
Gdansk, 80-147, Poland
Oddział Okulistyczny OSK,
Katowice, 40-760, Poland
Instituto Oftalmología de Alicante (Vissum)
Alicante, 03016, Spain
Centro Teknon-Institut de la Macula i de la Retina
Barcelona, 08022, Spain
Hospital La Paz
Madrid, 28046, Spain
Instituto Technologico de Oftalmologia S.L
Santiago de Compostela, 15705, Spain
Hospital General de Valencia
Valencia, 46014, Spain
St Paul's Eye Unit
Liverpool, L7 8XP, United Kingdom
Moorfields Eye Hospital
London, EC1V 2PD, United Kingdom
Southampton Eye Unit, Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Wolverhampton Eye Infirmary-New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (4)
Varma R, Haller JA, Kaiser PK. Improvement in Patient-Reported Visual Function After Ocriplasmin for Vitreomacular Adhesion: Results of the Microplasmin for Intravitreous Injection-Traction Release Without Surgical Treatment (MIVI-TRUST) Trials. JAMA Ophthalmol. 2015 Sep;133(9):997-1004. doi: 10.1001/jamaophthalmol.2015.1746.
PMID: 26068086DERIVEDFolgar FA, Toth CA, DeCroos FC, Girach A, Pakola S, Jaffe GJ. Assessment of retinal morphology with spectral and time domain OCT in the phase III trials of enzymatic vitreolysis. Invest Ophthalmol Vis Sci. 2012 Oct 25;53(11):7395-401. doi: 10.1167/iovs.12-10379.
PMID: 23033391DERIVEDStalmans 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.
PMID: 22894573DERIVEDDeCroos 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. doi: 10.1167/iovs.12-10370.
PMID: 22879421DERIVED
MeSH Terms
Interventions
Results Point of Contact
- Title
- Petra Kozma-Wiebe
- Organization
- ThromboGenics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2008
First Posted
November 26, 2008
Study Start
December 1, 2008
Primary Completion
June 1, 2010
Study Completion
July 1, 2010
Last Updated
December 17, 2014
Results First Posted
January 30, 2013
Record last verified: 2014-04