Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-006) 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
1 country
41
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.
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
Shorter than P25 for phase_3
41 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
October 28, 2008
CompletedFirst Posted
Study publicly available on registry
October 29, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
January 28, 2013
CompletedDecember 17, 2014
April 1, 2014
1.2 years
October 28, 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.
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
Secondary Outcomes (1)
Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28
Day 28
Study Arms (2)
125µg Ocriplasmin
EXPERIMENTAL125µg intravitreal injection of ocriplasmin
Placebo
PLACEBO COMPARATORplacebo intravitreal injection
Interventions
125µg ocriplasmin intravitreal injection
Eligibility Criteria
You may qualify if:
- 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)
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 (41)
Retinal Consultants of AZ
Phoenix, Arizona, 85014, United States
Assocaited Retina Consultants, Ltd.
Phoenix, Arizona, 85020, United States
Retina Centers, P.C.
Tucson, Arizona, 85704, United States
Retina Vitreous Associate Medical Group
Beverly Hills, California, 90211, United States
VMR Institute
Huntington Beach, California, 92647, United States
Jules Stein Eye Institute/UCLA
Los Angeles, California, 90095, United States
Southern California Desert Retina Consultants
Palm Springs, California, 92262, United States
Retinal Consultants Medical Group
Sacramento, California, 95819, United States
Rocky Mountain Lions Eye Institute
Aurora, Colorado, 80045-0510, United States
Colorado Retina Associates, PC
Denver, Colorado, 80230, United States
National Ophthalmologic Research Institute
Fort Meyers, Florida, 33912, United States
University of Miami-Bascom Palmer Eye Institute- Palm Beach
Palm Beach, Florida, 33418, United States
Sarasota Retina Institute
Sarasota, Florida, 34239, United States
Center for Retina and Macular Disease
Winter Haven, Florida, 33880, United States
Southeast Retina Center, PC
Augusta, Georgia, 30909, United States
Rush University Med. Ctr
Chicago, Illinois, 60612, United States
Midwest Eye Institute
Indianapolis, Indiana, 46290, United States
Univ. Of Kentuck/Kentucky-Clinic/Dept of Ophthal & VS
Lexington, Kentucky, 40536-0284, United States
Maine Vitreoretinal Consultants, LLC, PA
Bangor, Maine, 04401, United States
National Retina Institute
Towson, Maryland, 21204, United States
University of Michigan-Kellogg Eye Center
Ann Arbor, Michigan, 48105, United States
Kresge Eye Institute
Detroit, Michigan, 48201-1423, United States
Vitreo-Retinal Associates
Grand Rapids, Michigan, 49525, United States
Associated Retina Consultants
Royal Oak, Michigan, 48073, United States
Vitroretinal Surgery PA
Minneapolis, Minnesota, 55435, United States
Retina Vitreous Centre, PA
New Brunswick, New Jersey, 08901, United States
Retina Association of NJ
Teaneck, New Jersey, 07666, United States
New York Eye and Ear Infirmary
New York, New York, 10003, United States
Columbia University - Harkness Eye Institute
New York, New York, 10032, United States
Retina Vitreous Surgeons of Central NY
New York, New York, 13224, United States
Duke Eye Center
Durham, North Carolina, 27710, United States
Caroline Eye Associates
Southern Pines, North Carolina, 28387, United States
Wake Forest University Eye Center
Winston-Salem, North Carolina, 27157, United States
Retina Association of Cleveland
Lakewood, Ohio, 44107, United States
Pennsylvania Retina Specialists, P.C.
Camp Hill, Pennsylvania, 17011, United States
Allegheny Ophthalmic & Orbital Associates, PC
Pittsburgh, Pennsylvania, 15212, United States
Souteastern Retina Associates
Kingsport, Tennessee, 37660, United States
Austin Retina Associates
Austin, Texas, 78705, United States
Vitroretinal Consultants
Houston, Texas, 77030, United States
Valley Retina Institute, P.A.
McAllen, Texas, 78503, United States
Retinal Consultants of San Antonio
San Antonio, Texas, 78240, United States
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
- LTE60
- 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
October 28, 2008
First Posted
October 29, 2008
Study Start
December 1, 2008
Primary Completion
March 1, 2010
Study Completion
April 1, 2010
Last Updated
December 17, 2014
Results First Posted
January 28, 2013
Record last verified: 2014-04