Back to resultsTrial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-007) Trial.
Primary Purpose
Vitreomacular Adhesion
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ocriplasmin 125µg
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 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)
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 Diagnostic Center
- West Coast Retina Group, Inc
- California Retina Consultants
- Medeye
- Retina Specialists
- Paducah Retinal Center
- Tufts Medical Center
- Vision Research Center at Truman Medical Center
- Deleware Valley Retina Associates
- Capital Region Retina
- Southeast Clinical Research Assoicates, PA
- Dean A McGee Eye Institute
- Scheie Eye Institute, Penn Eye Care
- Black Hils regional Eye Institute
- Texas Retina Associates
- Retina Research Center
- Retina Consultants
- Medical Center Ophthalmology Assoc.
- Eye Care Associates
- Vitreoretinal Associates
- University Hospital Leuven
- University Hospital Brno
- University Hospital Hradec Kralove
- University Hospital Olomouc
- University Hospital Kralovske Vinohrady
- Central Military Hospital
- Gemini Eye Clinic
- Augenklinik-Universität Bonn
- St. Joseph Stift Bremen Abteilung für Augenheilkunde
- Städtische Kliniken Frankfurt am Main, Klinik für Augenheilkunde
- Universitäts-Augenklinik Frankfurt am Main
- Universität Göttingen
- Klinik und Poliklinik für Augenheilkunde
- Philipps Universität Marburg
- Augenklinik der Ludwig Maximilians Universität München
- Augenärzte am St. Franziskus Hospital
- Augenklinik im Dietrich-
- Indywidualna Specjalistyczna Praktyka Prywatna
- Oddział Okulistyczny OSK,
- Instituto Oftalmología de Alicante (Vissum)
- Centro Teknon-Institut de la Macula i de la Retina
- Hospital La Paz
- Instituto Technologico de Oftalmologia S.L
- Hospital General de Valencia
- St Paul's Eye Unit
- Moorfields Eye Hospital
- Southampton Eye Unit, Southampton General Hospital
- Wolverhampton Eye Infirmary-New Cross Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ocriplasmin 125µg
Placebo
Arm Description
125µg of ocriplasmin intravitreal injection
Intravitreal injection of placebo
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28
Proportion of subjects with total PVD at Day 28, as determined by masked investigator assessment of B-scan ultrasound.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00798317
Brief Title
Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-007) 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
June 2010 (Actual)
Study Completion Date
July 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
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.
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
Ocriplasmin 125µg
Arm Type
Experimental
Arm Description
125µg of ocriplasmin intravitreal injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intravitreal injection of placebo
Intervention Type
Drug
Intervention Name(s)
Ocriplasmin 125µg
Other Intervention Name(s)
Microplasmin
Intervention Description
125µg of ocriplasmin intravitreal injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intravitreal injection placebo.
Primary Outcome Measure Information:
Title
Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28
Description
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.
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28
Description
Proportion of subjects with total 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 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)
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 Diagnostic Center
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
Facility Name
West Coast Retina Group, Inc
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States
Facility Name
California Retina Consultants
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93103
Country
United States
Facility Name
Medeye
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Retina Specialists
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Paducah Retinal Center
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Vision Research Center at Truman Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Deleware Valley Retina Associates
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Capital Region Retina
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Southeast Clinical Research Assoicates, PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Dean A McGee Eye Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Scheie Eye Institute, Penn Eye Care
City
Philadelphia,
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Black Hils regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Texas Retina Associates
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Retina Research Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina Consultants
City
Fort Worth,
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Medical Center Ophthalmology Assoc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Eye Care Associates
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Vitreoretinal Associates
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
University Hospital Leuven
City
Leuven
Country
Belgium
Facility Name
University Hospital Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czech Republic
Facility Name
University Hospital Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
University Hospital Olomouc
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
University Hospital Kralovske Vinohrady
City
Prague
ZIP/Postal Code
100 34
Country
Czech Republic
Facility Name
Central Military Hospital
City
Prague
ZIP/Postal Code
169 02
Country
Czech Republic
Facility Name
Gemini Eye Clinic
City
Zlin
ZIP/Postal Code
760 01
Country
Czech Republic
Facility Name
Augenklinik-Universität Bonn
City
Bonn
ZIP/Postal Code
D-53127
Country
Germany
Facility Name
St. Joseph Stift Bremen Abteilung für Augenheilkunde
City
Bremen
ZIP/Postal Code
28209
Country
Germany
Facility Name
Städtische Kliniken Frankfurt am Main, Klinik für Augenheilkunde
City
Frankfurt am Main
ZIP/Postal Code
65929
Country
Germany
Facility Name
Universitäts-Augenklinik Frankfurt am Main
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universität Göttingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Klinik und Poliklinik für Augenheilkunde
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Philipps Universität Marburg
City
Marburg
ZIP/Postal Code
35037
Country
Germany
Facility Name
Augenklinik der Ludwig Maximilians Universität München
City
München
ZIP/Postal Code
80336
Country
Germany
Facility Name
Augenärzte am St. Franziskus Hospital
City
Münster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Augenklinik im Dietrich-
City
Neubrandenburg
ZIP/Postal Code
17036
Country
Germany
Facility Name
Indywidualna Specjalistyczna Praktyka Prywatna
City
Gdansk
ZIP/Postal Code
80-147
Country
Poland
Facility Name
Oddział Okulistyczny OSK,
City
Katowice
ZIP/Postal Code
40-760
Country
Poland
Facility Name
Instituto Oftalmología de Alicante (Vissum)
City
Alicante
ZIP/Postal Code
03016
Country
Spain
Facility Name
Centro Teknon-Institut de la Macula i de la Retina
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Instituto Technologico de Oftalmologia S.L
City
Santiago de Compostela
ZIP/Postal Code
15705
Country
Spain
Facility Name
Hospital General de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
St Paul's Eye Unit
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Moorfields Eye Hospital
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
Facility Name
Southampton Eye Unit, Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Wolverhampton Eye Infirmary-New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
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-007) Trial.
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