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

December 2, 2014 updated by: ThromboGenics

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
326

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium
        • University Hospital Leuven
  • Czech Republic
      • Brno, Czech Republic, 625 00
        • University Hospital Brno
      • Hradec Kralove, Czech Republic, 500 05
        • University hospital Hradec Králové
      • Olomouc, Czech Republic, 775 20
        • University Hospital Olomouc
      • Prague, Czech Republic, 100 34
        • University Hospital Královské Vinohrady
      • Prague, Czech Republic, 169 02
        • Central Military Hospital
      • Zlin, Czech Republic, 760 01
        • Gemini Eye Clinic
  • Germany
      • Bonn, Germany, D-53127
        • Augenklinik-Universität Bonn
      • Bremen, Germany, 28209
        • St. Joseph Stift Bremen Abteilung für Augenheilkunde
      • Frankfurt, Germany, 60590
        • Universitäts-Augenklinik Frankfurt am Main
      • Frankfurt am Main, Germany, 65929
        • Städtische Kliniken Frankfurt am Main, Klinik für Augenheilkunde
      • Göttingen, Germany, 37075
        • Universität Göttingen
      • Leipzig, Germany, 04103
        • Klinik und Poliklinik für Augenheilkunde
      • Marburg, Germany, 35037
        • Philipps Universität Marburg
      • München, Germany, 80336
        • Augenklinik der Ludwig Maximilians Universität München
      • Münster, Germany, 48145
        • Augenarzte am St. Franziskus Hospital
      • Neubrandenburg, Germany, 17036
        • Augenklinik im Dietrich-
  • Poland
      • Gdansk, Poland, 80-147
        • Indywidualna Specjalistyczna Praktyka Prywatna
      • Katowice, Poland, 40-760
        • Oddział Okulistyczny OSK,
  • Spain
      • Alicante, Spain, 03016
        • Instituto Oftalmología de Alicante (Vissum)
      • Barcelona, Spain, 08022
        • Centro Teknon-Institut de la Macula i de la Retina
      • Madrid, Spain, 28046
        • Hospital La Paz
      • Santiago de Compostela, Spain, 15705
        • Instituto Technologico de Oftalmologia S.L
      • Valencia, Spain, 46014
        • Hospital General de Valencia
  • United Kingdom
      • Liverpool, United Kingdom, L7 8XP
        • St Paul's Eye Unit
      • London, United Kingdom, EC1V 2PD
        • Moorfields Eye Hospital
      • Southampton, United Kingdom, SO16 6YD
        • Southampton Eye Unit, Southampton General Hospital
      • Wolverhampton, United Kingdom, WV10 0QP
        • Wolverhampton Eye Infirmary-New Cross Hospital
  • United States
    • California
      • Campbell, California, United States, 95008
        • Retinal Diagnostic Center
      • San Francisco, California, United States, 94107
        • West Coast Retina Group, Inc
      • Santa Barbara, California, United States, 93103
        • California Retina Consultants
    • Florida
      • Miami, Florida, United States, 33143
        • Medeye
      • Pensacola, Florida, United States, 32503
        • Retina Specialists
    • Kentucky
      • Paducah, Kentucky, United States, 42001
        • Paducah Retinal Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Vision Research Center at Truman Medical Center
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Deleware Valley Retina Associates
    • New York
      • Albany, New York, United States, 12206
        • Capital Region Retina
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Southeast Clinical Research Assoicates, PA
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Dean A McGee Eye Institute
    • Pennsylvania
      • Philadelphia,, Pennsylvania, United States, 19104
        • Scheie Eye Institute, Penn Eye Care
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hils regional Eye Institute
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Retina Associates
      • Austin, Texas, United States, 78705
        • Retina Research Center
      • Fort Worth,, Texas, United States, 76104
        • Retina Consultants
      • San Antonio, Texas, United States, 78240
        • Medical Center Ophthalmology Assoc.
      • Tyler, Texas, United States, 75701
        • Eye Care Associates
    • Washington
      • Seattle, Washington, United States, 98104
        • VitreoRetinal Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ocriplasmin 125µg
125µg of ocriplasmin intravitreal injection
Drug: Ocriplasmin 125µg
125µg of ocriplasmin intravitreal injection
Other Names:
  • Microplasmin
Placebo Comparator: Placebo
Intravitreal injection of placebo
Drug: Placebo
Intravitreal injection placebo.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28
Time Frame: 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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28
Time Frame: Day 28
Proportion of subjects with total PVD at Day 28, as determined by masked investigator assessment of B-scan ultrasound.
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ThromboGenics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TG-MV-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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