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

Vitreomacular Adhesion Clinical Trial

Official title:

A Randomized, Placebo Controlled, Double-masked, Multicenter Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00798317
• Other study ID #: TG-MV-007
• Status: Completed
• Phase: Phase 3
• First received: November 25, 2008
• Last updated: December 2, 2014
• Start date: December 2008
• Est. completion date: July 2010

Study information

• Verified date: April 2014
• Source: ThromboGenics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesPoland: Ministry of HealthPortugal: National Pharmacy and Medicines InstituteSpain: Spanish Agency of MedicinesUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tissue Adhesions
• Vitreomacular Adhesion

Intervention

Drug:
• Ocriplasmin 125µg
125µg of ocriplasmin intravitreal injection
• Placebo
Intravitreal injection placebo.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
ThromboGenics

Countries where clinical trial is conducted

United States,  Belgium,  Czech Republic,  Germany,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 28	No
Secondary	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.	Day 28	No