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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ThromboGenics
ClinicalTrials.gov Identifier:
NCT00412451
First received: December 14, 2006
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Diabetic Macular Edema
Drug: ocriplasmin
Other: Sham injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by ThromboGenics:

Primary Outcome Measures:
  • PVD Induction [ Time Frame: Day 14 post-injection ] [ Designated as safety issue: No ]
    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)


Enrollment: 51
Study Start Date: December 2006
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ocriplasmin 25µg
25µg ocriplasmin intravitreal injection versus sham injection
Drug: ocriplasmin
Intravitreal injection, single administration
Other Name: microplasmin
Experimental: Ocriplasmin 75µg
75µg ocriplasmin intravitreal injection versus sham injection
Drug: ocriplasmin
Intravitreal injection, single administration
Other Name: microplasmin
Experimental: Ocriplasmin 125µg
125µg ocriplasmin intravitreal injection versus sham injection
Drug: ocriplasmin
Intravitreal injection, single administration
Other Name: microplasmin
Sham Comparator: sham injection
Sham injection
Other: Sham injection
Sham intravitreal injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00412451

Locations
Belgium
ZNA OCMW Antwerpen
Antwerpen, Belgium, 2020
University Hospital of Ghent
Ghent, Belgium, B-9000
University Hospital Leuven
Leuven, Belgium
Germany
Ludwig Maximillian University
Munich, Germany
Italy
University of Milan
Milan, Italy
Azienda Ospedaliero-Universitaria Pisana
Pisa, Italy
Institute of Ophtalmology, Policlinico A: Gemelli (University Hospital),Catholic University of Sacred Heart
Rome, Italy, 00168
Ospedale di Circolo di Varese, Insubria University
Varese, Italy, 21100
Netherlands
Academic Hospital Groningen
Groningen, Netherlands, 9700 RB
Het Oogziekenhuis Rotterdam
Rotterdam, Netherlands, 3011 BH
Spain
Institut de Microcirurgia Ocular de Barcelona
Barcelona, Spain, 08022
Hospital Vall D'Hebron
Barcelona, Spain, 08035
Instituto Technologico de Oftalmologia SL.
Santiago de Compostela, Spain
United Kingdom
Royal Liverpool & Broadgreen Hospital
Liverpool, United Kingdom, L7 8XP
Moorfields Eye Hospital
London, United Kingdom, EC1V 2PD
Sponsors and Collaborators
ThromboGenics
  More Information

No publications provided

Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT00412451     History of Changes
Other Study ID Numbers: TG-MV-002
Study First Received: December 14, 2006
Results First Received: July 4, 2013
Last Updated: April 4, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Belgium: Ministry of Social Affairs, Public Health and the Environment
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Ministry of Health

Keywords provided by ThromboGenics:
Diabetic Macular Edema
PVD
DME
Diabetic Retinopathy

Additional relevant MeSH terms:
Edema
Macular Edema
Vitreous Detachment
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 21, 2014