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

Sponsored by:	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

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Microplasmin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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.

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:

Resolution of macular edema [ Time Frame: 6 months post-injection ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	December 2006
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Microplasmin Intravitreal injection, single administration
2: Experimental	Drug: Microplasmin Intravitreal injection, single administration
3: Experimental	Drug: Microplasmin Intravitreal injection, single administration
4: Sham Comparator 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

Contacts

Contact: Edith Van Dijkman	+31365232009	edith.vandijkman@thrombogenics.com
Contact: Stephen Pakola, MD	+1 212 201 0920 x 277	steve.pakola@thrombogenics.com

Locations

Belgium
University Hospital Leuven	Recruiting
Leuven, Belgium
Contact: , MD
Principal Investigator: Peter Stalmans, MD
ZNA OCMW Antwerpen	Recruiting
Antwerpen, Belgium, 2020
Principal Investigator: Marc De Smet, MD
University Hospital of Ghent	Recruiting
Ghent, Belgium, B-9000
Principal Investigator: Elizabeth Van Aken, MD
Germany
Ludwig Maximillian University	Active, not recruiting
Munich, Germany
Italy
Institute of Ophtalmology, Policlinico A: Gemelli (University Hospital),Catholic University of Sacred Heart	Recruiting
Rome, Italy, 00168
Principal Investigator: Benedetto Flasini, Dr.
Ospedale di Circolo di Varese, Insubria University	Recruiting
Varese, Italy, 21100
Principal Investigator: Claudio Azzolini, Porf.
University of Milan	Recruiting
Milan, Italy
Principal Investigator: Luigi Bonavia, Dr.
Azienda Ospedaliero-Universitaria Pisana	Recruiting
Pisa, Italy
Principal Investigator: Stanislao Rizzo, Dr.
Netherlands
Het Oogziekenhuis Rotterdam	Recruiting
Rotterdam, Netherlands, 3011 BH
Principal Investigator: Marc Veckeneer, MD
Academic Hospital Groningen	Recruiting
Groningen, Netherlands, 9700 RB
Principal Investigator: JMM Hooymans, Prof. Dr.
Spain
Institut de Microcirurgia Ocular de Barcelona	Recruiting
Barcelona, Spain, 08022
Principal Investigator: Borja Corcóstegui, MD
Instituto Technologico de Oftalmologia SL.	Recruiting
Santiago de Compostela, Spain
Principal Investigator: Joaquin Marticorena, Dr.
United Kingdom
Moorfields Eye Hospital	Recruiting
London, United Kingdom, EC1V 2PD
Principal Investigator: Adnan Tufail, MD
Royal Liverpool & Broadgreen Hospital	Recruiting
Liverpool, United Kingdom, L7 8XP
Principal Investigator: Heinrich Heimann, MD

Sponsors and Collaborators

ThromboGenics

Investigators

Principal Investigator:

Anselm Kampik, Prof. Dr.

LMU Augenklinik Munich - Germany

More Information

Responsible Party:	ThromboGenics ( Edith Van Dijkman )
Study ID Numbers:	TG-MV-002
Study First Received:	December 14, 2006
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00412451
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

Study placed in the following topic categories:

Clotrimazole
Eye Diseases
Miconazole
Tioconazole
Edema
Macular Degeneration
Retinal Degeneration

Macular Edema
Signs and Symptoms
Diabetic Retinopathy
Salicylhydroxamic acid
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:

Trypanocidal Agents
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents

Therapeutic Uses
Antifungal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009