Clinical trial NCT00781859: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vitreomacular Adhesion
Lead sponsor: ThromboGenics
Sponsor class: INDUSTRY
First posted: 2008-10-29
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28.
timeFrame: Day 28
Secondary outcomes:
measure: Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28
timeFrame: Day 28
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Consultants of AZ
state: Arizona
city: Phoenix
country: United States
facility: Assocaited Retina Consultants, Ltd.
state: Arizona
city: Tucson
country: United States
facility: Retina Centers, P.C.
state: Arizona
city: Beverly Hills
country: United States
facility: Retina Vitreous Associate Medical Group
state: California
city: Huntington Beach
country: United States
facility: VMR Institute
state: California
city: Los Angeles
country: United States
facility: Jules Stein Eye Institute/UCLA
state: California
city: Palm Springs
country: United States
facility: Southern California Desert Retina Consultants
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group
state: California
city: Aurora
country: United States
facility: Rocky Mountain Lions Eye Institute
state: Colorado
city: Denver
country: United States
facility: Colorado Retina Associates, PC
state: Colorado
city: Ft. Meyers
country: United States
facility: National Ophthalmologic Research Institute
state: Florida
city: Palm Beach
country: United States
facility: University of Miami-Bascom Palmer Eye Institute- Palm Beach
state: Florida
city: Sarasota
country: United States
facility: Sarasota Retina Institute
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina and Macular Disease
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center, PC
state: Georgia
city: Chicago,
country: United States
facility: Rush University Med. Ctr
state: Illinois
city: Indianapolis,
country: United States
facility: Midwest Eye Institute
state: Indiana
city: Lexington
country: United States
facility: Univ. Of Kentuck/Kentucky-Clinic/Dept of Ophthal & VS
state: Kentucky
city: Bangor
country: United States
facility: Maine Vitreoretinal Consultants, LLC, PA
state: Maine
city: Towson
country: United States
facility: National Retina Institute
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan-Kellogg Eye Center
state: Michigan
city: Detroit
country: United States
facility: Kresge Eye Institute
state: Michigan
city: Grand Rapids
country: United States
facility: Vitreo-Retinal Associates
state: Michigan
city: Royal Oak,
country: United States
facility: Associated Retina Consultants
state: Michigan
city: Minneapolis
country: United States
facility: Vitroretinal Surgery PA
state: Minnesota
city: New Brunswick
country: United States
facility: Retina Vitreous Centre, PA
state: New Jersey
city: Teaneck
country: United States
facility: Retina Association of NJ
state: New Jersey
city: New York
country: United States
facility: New York Eye and Ear Infirmary
state: New York
city: New York
country: United States
facility: Columbia University - Harkness Eye Institute
state: New York
city: New York
country: United States
facility: Retina Vitreous Surgeons of Central NY
state: New York
city: Durham
country: United States
facility: Duke Eye Center
state: North Carolina
city: Southern Pines
country: United States
facility: Caroline Eye Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Eye Center
state: North Carolina
city: Lakewood
country: United States
facility: Retina Association of Cleveland
state: Ohio
city: Camp Hill
country: United States
facility: Pennsylvania Retina Specialists, P.C.
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Ophthalmic & Orbital Associates, PC
state: Pennsylvania
city: Kingsport
country: United States
facility: Souteastern Retina Associates
state: Tennessee
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Houston
country: United States
facility: Vitroretinal Consultants
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute, P.A.
state: Texas
city: San Antonio
country: United States
facility: Retinal Consultants of San Antonio
state: Texas
Study officials:
References:
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.
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.
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.
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.