Back to resultsTrial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-006) Trial.
Primary Purpose
Vitreomacular Adhesion
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
125 µg Ocriplasmin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Vitreomacular Adhesion
Eligibility 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).
Sites / Locations
- Retinal Consultants of AZ
- Assocaited Retina Consultants, Ltd.
- Retina Centers, P.C.
- Retina Vitreous Associate Medical Group
- VMR Institute
- Jules Stein Eye Institute/UCLA
- Southern California Desert Retina Consultants
- Retinal Consultants Medical Group
- Rocky Mountain Lions Eye Institute
- Colorado Retina Associates, PC
- National Ophthalmologic Research Institute
- University of Miami-Bascom Palmer Eye Institute- Palm Beach
- Sarasota Retina Institute
- Center for Retina and Macular Disease
- Southeast Retina Center, PC
- Rush University Med. Ctr
- Midwest Eye Institute
- Univ. Of Kentuck/Kentucky-Clinic/Dept of Ophthal & VS
- Maine Vitreoretinal Consultants, LLC, PA
- National Retina Institute
- University of Michigan-Kellogg Eye Center
- Kresge Eye Institute
- Vitreo-Retinal Associates
- Associated Retina Consultants
- Vitroretinal Surgery PA
- Retina Vitreous Centre, PA
- Retina Association of NJ
- New York Eye and Ear Infirmary
- Columbia University - Harkness Eye Institute
- Retina Vitreous Surgeons of Central NY
- Duke Eye Center
- Caroline Eye Associates
- Wake Forest University Eye Center
- Retina Association of Cleveland
- Pennsylvania Retina Specialists, P.C.
- Allegheny Ophthalmic & Orbital Associates, PC
- Souteastern Retina Associates
- Austin Retina Associates
- Vitroretinal Consultants
- Valley Retina Institute, P.A.
- Retinal Consultants of San Antonio
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
125µg Ocriplasmin
Placebo
Arm Description
125µg intravitreal injection of ocriplasmin
placebo intravitreal injection
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00781859
Brief Title
Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-006) Trial.
Official Title
A Randomized, Placebo Controlled, Double-masked, Multicenter Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ThromboGenics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitreomacular Adhesion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
326 (Actual)
8. Arms, Groups, and Interventions
Arm Title
125µg Ocriplasmin
Arm Type
Experimental
Arm Description
125µg intravitreal injection of ocriplasmin
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo intravitreal injection
Intervention Type
Drug
Intervention Name(s)
125 µg Ocriplasmin
Other Intervention Name(s)
microplasmin
Intervention Description
125µg ocriplasmin intravitreal injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo intravitreal injection
Primary Outcome Measure Information:
Title
Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28.
Description
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.
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28
Description
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.
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
Retinal Consultants of AZ
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Assocaited Retina Consultants, Ltd.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Retina Centers, P.C.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Retina Vitreous Associate Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
VMR Institute
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Jules Stein Eye Institute/UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Southern California Desert Retina Consultants
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Retinal Consultants Medical Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Rocky Mountain Lions Eye Institute
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045-0510
Country
United States
Facility Name
Colorado Retina Associates, PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
National Ophthalmologic Research Institute
City
Ft. Meyers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
University of Miami-Bascom Palmer Eye Institute- Palm Beach
City
Palm Beach
State/Province
Florida
ZIP/Postal Code
33418
Country
United States
Facility Name
Sarasota Retina Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Center for Retina and Macular Disease
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Southeast Retina Center, PC
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Rush University Med. Ctr
City
Chicago,
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Midwest Eye Institute
City
Indianapolis,
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Univ. Of Kentuck/Kentucky-Clinic/Dept of Ophthal & VS
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0284
Country
United States
Facility Name
Maine Vitreoretinal Consultants, LLC, PA
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
National Retina Institute
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
University of Michigan-Kellogg Eye Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Kresge Eye Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1423
Country
United States
Facility Name
Vitreo-Retinal Associates
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Facility Name
Associated Retina Consultants
City
Royal Oak,
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Vitroretinal Surgery PA
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Retina Vitreous Centre, PA
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Retina Association of NJ
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
New York Eye and Ear Infirmary
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Columbia University - Harkness Eye Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Retina Vitreous Surgeons of Central NY
City
New York
State/Province
New York
ZIP/Postal Code
13224
Country
United States
Facility Name
Duke Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Caroline Eye Associates
City
Southern Pines
State/Province
North Carolina
ZIP/Postal Code
28387
Country
United States
Facility Name
Wake Forest University Eye Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Retina Association of Cleveland
City
Lakewood
State/Province
Ohio
ZIP/Postal Code
44107
Country
United States
Facility Name
Pennsylvania Retina Specialists, P.C.
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Allegheny Ophthalmic & Orbital Associates, PC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Souteastern Retina Associates
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Austin Retina Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Vitroretinal Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Valley Retina Institute, P.A.
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Retinal Consultants of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26068086
Citation
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.
Results Reference
derived
PubMed Identifier
23033391
Citation
Folgar 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.
Results Reference
derived
PubMed Identifier
22894573
Citation
Stalmans 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.
Results Reference
derived
PubMed Identifier
22879421
Citation
DeCroos 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.
Results Reference
derived
Learn more about this trial
Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-006) Trial.
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