Clinical trial NCT00798317: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vitreomacular Adhesion
Lead sponsor: ThromboGenics
Sponsor class: INDUSTRY
First posted: 2008-11-26
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: 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.


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).

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: Campbell
country: United States
facility: Retinal Diagnostic Center
state: California
city: San Francisco
country: United States
facility: West Coast Retina Group, Inc
state: California
city: Santa Barbara
country: United States
facility: California Retina Consultants
state: California
city: Miami
country: United States
facility: Medeye
state: Florida
city: Pensacola
country: United States
facility: Retina Specialists
state: Florida
city: Paducah
country: United States
facility: Paducah Retinal Center
state: Kentucky
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Kansas City
country: United States
facility: Vision Research Center at Truman Medical Center
state: Missouri
city: Lawrenceville
country: United States
facility: Deleware Valley Retina Associates
state: New Jersey
city: Albany
country: United States
facility: Capital Region Retina
state: New York
city: Charlotte
country: United States
facility: Southeast Clinical Research Assoicates, PA
state: North Carolina
city: Oklahoma City
country: United States
facility: Dean A McGee Eye Institute
state: Oklahoma
city: Philadelphia,
country: United States
facility: Scheie Eye Institute, Penn Eye Care
state: Pennsylvania
city: Rapid City
country: United States
facility: Black Hils regional Eye Institute
state: South Dakota
city: Arlington
country: United States
facility: Texas Retina Associates
state: Texas
city: Austin
country: United States
facility: Retina Research Center
state: Texas
city: Fort Worth,
country: United States
facility: Retina Consultants
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Assoc.
state: Texas
city: Tyler
country: United States
facility: Eye Care Associates
state: Texas
city: Seattle
country: United States
facility: Vitreoretinal Associates
state: Washington
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Brno
country: Czech Republic
facility: University Hospital Brno
city: Hradec Kralove
country: Czech Republic
facility: University Hospital Hradec Kralove
city: Olomouc
country: Czech Republic
facility: University Hospital Olomouc
city: Prague
country: Czech Republic
facility: University Hospital Kralovske Vinohrady
city: Prague
country: Czech Republic
facility: Central Military Hospital
city: Zlin
country: Czech Republic
facility: Gemini Eye Clinic
city: Bonn
country: Germany
facility: Augenklinik-Universität Bonn
city: Bremen
country: Germany
facility: St. Joseph Stift Bremen Abteilung für Augenheilkunde
city: Frankfurt am Main
country: Germany
facility: Städtische Kliniken Frankfurt am Main, Klinik für Augenheilkunde
city: Frankfurt
country: Germany
facility: Universitäts-Augenklinik Frankfurt am Main
city: Göttingen
country: Germany
facility: Universität Göttingen
city: Leipzig
country: Germany
facility: Klinik und Poliklinik für Augenheilkunde
city: Marburg
country: Germany
facility: Philipps Universität Marburg
city: München
country: Germany
facility: Augenklinik der Ludwig Maximilians Universität München
city: Münster
country: Germany
facility: Augenärzte am St. Franziskus Hospital
city: Neubrandenburg
country: Germany
facility: Augenklinik im Dietrich-
city: Gdansk
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Prywatna
city: Katowice
country: Poland
facility: Oddział Okulistyczny OSK,
city: Alicante
country: Spain
facility: Instituto Oftalmología de Alicante (Vissum)
city: Barcelona
country: Spain
facility: Centro Teknon-Institut de la Macula i de la Retina
city: Madrid
country: Spain
facility: Hospital La Paz
city: Santiago de Compostela
country: Spain
facility: Instituto Technologico de Oftalmologia S.L
city: Valencia
country: Spain
facility: Hospital General de Valencia
city: Liverpool
country: United Kingdom
facility: St Paul's Eye Unit
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
city: Southampton
country: United Kingdom
facility: Southampton Eye Unit, Southampton General Hospital
city: Wolverhampton
country: United Kingdom
facility: Wolverhampton Eye Infirmary-New Cross Hospital
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.