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Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-007) Trial.

NCT ID: NCT00798317

Last Updated: 2014-12-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

326 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Vitreomacular Adhesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ocriplasmin 125µg

125µg of ocriplasmin intravitreal injection

Group Type EXPERIMENTAL

Ocriplasmin 125µg

Intervention Type DRUG

125µg of ocriplasmin intravitreal injection

Placebo

Intravitreal injection of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intravitreal injection placebo.

Interventions

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Ocriplasmin 125µg

125µg of ocriplasmin intravitreal injection

Intervention Type DRUG

Placebo

Intravitreal injection placebo.

Intervention Type DRUG

Other Intervention Names

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Microplasmin

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ThromboGenics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Retinal Diagnostic Center

Campbell, California, United States

Site Status

West Coast Retina Group, Inc

San Francisco, California, United States

Site Status

California Retina Consultants

Santa Barbara, California, United States

Site Status

Medeye

Miami, Florida, United States

Site Status

Retina Specialists

Pensacola, Florida, United States

Site Status

Paducah Retinal Center

Paducah, Kentucky, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Vision Research Center at Truman Medical Center

Kansas City, Missouri, United States

Site Status

Deleware Valley Retina Associates

Lawrenceville, New Jersey, United States

Site Status

Capital Region Retina

Albany, New York, United States

Site Status

Southeast Clinical Research Assoicates, PA

Charlotte, North Carolina, United States

Site Status

Dean A McGee Eye Institute

Oklahoma City, Oklahoma, United States

Site Status

Scheie Eye Institute, Penn Eye Care

Philadelphia, Pennsylvania, United States

Site Status

Black Hils regional Eye Institute

Rapid City, South Dakota, United States

Site Status

Texas Retina Associates

Arlington, Texas, United States

Site Status

Retina Research Center

Austin, Texas, United States

Site Status

Retina Consultants

Fort Worth, Texas, United States

Site Status

Medical Center Ophthalmology Assoc.

San Antonio, Texas, United States

Site Status

Eye Care Associates

Tyler, Texas, United States

Site Status

Vitreoretinal Associates

Seattle, Washington, United States

Site Status

University Hospital Leuven

Leuven, , Belgium

Site Status

University Hospital Brno

Brno, , Czechia

Site Status

University Hospital Hradec Kralove

Hradec Králové, , Czechia

Site Status

University Hospital Olomouc

Olomouc, , Czechia

Site Status

University Hospital Kralovske Vinohrady

Prague, , Czechia

Site Status

Central Military Hospital

Prague, , Czechia

Site Status

Gemini Eye Clinic

Zlín, , Czechia

Site Status

Augenklinik-Universität Bonn

Bonn, , Germany

Site Status

St. Joseph Stift Bremen Abteilung für Augenheilkunde

Bremen, , Germany

Site Status

Universitäts-Augenklinik Frankfurt am Main

Frankfurt, , Germany

Site Status

Städtische Kliniken Frankfurt am Main, Klinik für Augenheilkunde

Frankfurt am Main, , Germany

Site Status

Universität Göttingen

Göttingen, , Germany

Site Status

Klinik und Poliklinik für Augenheilkunde

Leipzig, , Germany

Site Status

Philipps Universität Marburg

Marburg, , Germany

Site Status

Augenklinik der Ludwig Maximilians Universität München

München, , Germany

Site Status

Augenärzte am St. Franziskus Hospital

Münster, , Germany

Site Status

Augenklinik im Dietrich-

Neubrandenburg, , Germany

Site Status

Indywidualna Specjalistyczna Praktyka Prywatna

Gdansk, , Poland

Site Status

Oddział Okulistyczny OSK,

Katowice, , Poland

Site Status

Instituto Oftalmología de Alicante (Vissum)

Alicante, , Spain

Site Status

Centro Teknon-Institut de la Macula i de la Retina

Barcelona, , Spain

Site Status

Hospital La Paz

Madrid, , Spain

Site Status

Instituto Technologico de Oftalmologia S.L

Santiago de Compostela, , Spain

Site Status

Hospital General de Valencia

Valencia, , Spain

Site Status

St Paul's Eye Unit

Liverpool, , United Kingdom

Site Status

Moorfields Eye Hospital

London, , United Kingdom

Site Status

Southampton Eye Unit, Southampton General Hospital

Southampton, , United Kingdom

Site Status

Wolverhampton Eye Infirmary-New Cross Hospital

Wolverhampton, , United Kingdom

Site Status

Countries

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United States Belgium Czechia Germany Poland Spain United Kingdom

References

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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.

Reference Type DERIVED
PMID: 26068086 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23033391 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22894573 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22879421 (View on PubMed)

Other Identifiers

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TG-MV-007

Identifier Type: -

Identifier Source: org_study_id