A Study to Compare Multiple Doses Intravitreal Microplasmin for Treatment of Patients With Vitreomacular Traction (MIVI-IIt)

December 2, 2014 updated by: ThromboGenics

A Randomized, Sham-Injection Controlled, Double-Masked, Ascending-Dose, Dose-Range-Finding Trial of Microplasmin Intravitreal Injection for Non-Surgical Posterior Vitreous Detachment (PVD) Induction for Treatment of Vitreomacular Traction (VMT).

A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with vitreomacular traction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

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
      • Antwerpen, Belgium, 2020
        • ZNA OCMW Antwerpen
      • Ghent, Belgium, B-9000
        • University Hospital of Ghent
      • Leuven, Belgium
        • Universitaire Ziekenhuizen K.U.Leuven
  • Germany
      • Munchen, Germany, 80336
        • Augenklinik der Universitat Munchen

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients >_ 18 years of age with vitreomacular traction

Exclusion Criteria:

  • PVD present at baseline
  • Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR)
  • Vitreous hemorrhage
  • Patients who have had a vitrectomy in the study eye at any time

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
Intervention / Treatment
Experimental: ocriplasmin 75µg single injection
Ocriplasmin 75µg single injection versus sham injection
Drug: ocriplasmin
Intravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin.
Other Names:
  • microplasmin
Drug: ocriplasmin
Intravitreal injection of ocriplasmin solution containing 125µg of ocriplasmin with up to 2 additional (open label) 125µg ocriplasmin injection at 1 month interval.
Other Names:
  • microplasmin
Experimental: ocriplasmin 125µg single injection
Ocriplasmin 125µg single injection versus sham injection
Drug: ocriplasmin
Intravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin.
Other Names:
  • microplasmin
Drug: ocriplasmin
Intravitreal injection of ocriplasmin solution containing 125µg of ocriplasmin with up to 2 additional (open label) 125µg ocriplasmin injection at 1 month interval.
Other Names:
  • microplasmin
Experimental: ocriplasmin 175µg single injection
Ocriplasmin 175µg single injection versus sham injection
Drug: ocriplasmin
Intravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin.
Other Names:
  • microplasmin
Drug: ocriplasmin
Intravitreal injection of ocriplasmin solution containing 125µg of ocriplasmin with up to 2 additional (open label) 125µg ocriplasmin injection at 1 month interval.
Other Names:
  • microplasmin
Experimental: ocriplasmin 125µg multiple injections
Ocriplasmin 125µg multiple injections. Subjects who did not achieve resolution of VMT by the day 28 visit (i.e. non-responders) were given an open-label injection of ocriplasmin 125µg. Subjects who still did not achieve resolution of VMT by the day 56 visit were given a second open-label injection of ocriplasmin 125µg.
Drug: ocriplasmin
Intravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin.
Other Names:
  • microplasmin
Drug: ocriplasmin
Intravitreal injection of ocriplasmin solution containing 125µg of ocriplasmin with up to 2 additional (open label) 125µg ocriplasmin injection at 1 month interval.
Other Names:
  • microplasmin
Sham Comparator: sham injection
Drug: Sham Comparator
Intravitreal sham injection
Other Names:
  • microplasmin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of Subjects With Total PVD at the First Day 14 Post-injection Visit (Vitreous Detachment to the Equator) as Determined by Masked Central Reading Center (CRC) Evaluation of B-scan Imaging.
Time Frame: Day 14
Day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resolution of Vitreomacular Traction (Investigator's Assessment)
Time Frame: Day 28
Resolution of VMT was evaluated by the investigator using optical coherence tomography (OCT).Resolution of VMT was defined as a change from baseline status of Yes to post-injection status of No and was evaluated by the investigator using OCT. Subjects undergoing vitrectomy had their last observation prior to vitrectomy carried forward.
Day 28

Collaborators and Investigators

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

Sponsor

ThromboGenics

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

February 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

February 14, 2007

First Submitted That Met QC Criteria

February 14, 2007

First Posted (Estimate)

February 15, 2007

Study Record Updates

Last Update Posted (Estimate)

December 17, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TG-MV-004
  • MIVI-IIT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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