A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With DME - Full Text View

Sponsor:	ThromboGenics
Information provided by:	ThromboGenics
ClinicalTrials.gov Identifier:	NCT00412451

Purpose

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

Condition	Intervention	Phase
Diabetic Macular Edema	Drug: Microplasmin Other: Sham injection	Phase II

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 PVD Induction for Treatment of Diabetic Macular Edema.

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Microplasmin

U.S. FDA Resources

Further study details as provided by ThromboGenics:

Primary Outcome Measures:

PVD induction [ Time Frame: Day 14 post-injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

measures of disease status and safety [ Time Frame: 6 months post-injection ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
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: 1	Drug: Microplasmin Intravitreal injection, single administration
Experimental: 2	Drug: Microplasmin Intravitreal injection, single administration
Experimental: 3	Drug: Microplasmin Intravitreal injection, single administration
Sham Comparator: 4 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

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

Investigators

Principal Investigator:

Anselm Kampik, Prof. Dr.

LMU Augenklinik Munich - Germany

More Information

No publications provided

Responsible Party:	Edith Van Dijkman, ThromboGenics
ClinicalTrials.gov Identifier:	NCT00412451 History of Changes
Other Study ID Numbers:	TG-MV-002
Study First Received:	December 14, 2006
Last Updated:	February 3, 2011
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
Signs and Symptoms
Macular Degeneration

Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on February 13, 2012