A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With Diabetic Macular Edema (DME) (MIVI-II)

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 DME.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

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
        • University Hospital Leuven
  • Germany
      • Munich, Germany
        • Ludwig Maximillian University
  • Italy
      • Milan, Italy
        • University of Milan
      • Pisa, Italy
        • Azienda Ospedaliero-Universitaria Pisana
      • Rome, Italy, 00168
        • Institute of Ophtalmology, Policlinico A: Gemelli (University Hospital),Catholic University of Sacred Heart
      • Varese, Italy, 21100
        • Ospedale di Circolo di Varese, Insubria University
  • Netherlands
      • Groningen, Netherlands, 9700 RB
        • Academic hospital Groningen
      • Rotterdam, Netherlands, 3011 BH
        • Het Oogziekenhuis Rotterdam
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Barcelona, Spain, 08022
        • Institut de Microcirurgia Ocular de Barcelona
      • Santiago de Compostela, Spain
        • Instituto Technologico de Oftalmologia SL.
  • United Kingdom
      • Liverpool, United Kingdom, L7 8XP
        • Royal Liverpool & Broadgreen Hospital
      • London, United Kingdom, EC1V 2PD
        • Moorfields Eye Hospital

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 include:

  • patients >18 years of age with Diabetic Macular Edema

Exclusion Criteria include:

  • PVD present at baseline
  • Vitreous hemorrhage
  • Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR)
  • 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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ocriplasmin 25µg
25µg ocriplasmin intravitreal injection versus sham injection
Drug: ocriplasmin
Intravitreal injection, single administration
Other Names:
  • microplasmin
EXPERIMENTAL: Ocriplasmin 75µg
75µg ocriplasmin intravitreal injection versus sham injection
Drug: ocriplasmin
Intravitreal injection, single administration
Other Names:
  • microplasmin
EXPERIMENTAL: Ocriplasmin 125µg
125µg ocriplasmin intravitreal injection versus sham injection
Drug: ocriplasmin
Intravitreal injection, single administration
Other Names:
  • microplasmin
SHAM_COMPARATOR: sham injection
Sham injection
Other: Sham injection
Sham intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PVD Induction
Time Frame: Day 14 post-injection
The primary efficacy variable was the proportion of patients with total posterior vitreous detachment (PVD) on Day 14 as determined by a masked central reading center (CRC) using 4-quadrant B-scan and optical coherence tomography (OCT)
Day 14 post-injection

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

December 1, 2006

Primary Completion (ACTUAL)

January 1, 2010

Study Completion (ACTUAL)

March 1, 2010

Study Registration Dates

First Submitted

December 14, 2006

First Submitted That Met QC Criteria

December 14, 2006

First Posted (ESTIMATE)

December 18, 2006

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-002

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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