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Sponsored by: |
ThromboGenics |
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Information provided by: | ThromboGenics |
ClinicalTrials.gov Identifier: | NCT00412451 |
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: | 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. |
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
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2: Experimental |
Drug: Microplasmin
Intravitreal injection, single administration
|
3: Experimental |
Drug: Microplasmin
Intravitreal injection, single administration
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4: Sham Comparator
Sham injection
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Other: Sham injection
Sham intravitreal injection
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria include:
Exclusion Criteria include:
Belgium | |
University Hospital Leuven | |
Leuven, Belgium | |
ZNA OCMW Antwerpen | |
Antwerpen, Belgium, 2020 | |
University Hospital of Ghent | |
Ghent, Belgium, B-9000 | |
Germany | |
Ludwig Maximillian University | |
Munich, Germany | |
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 | |
University of Milan | |
Milan, Italy | |
Azienda Ospedaliero-Universitaria Pisana | |
Pisa, Italy | |
Netherlands | |
Het Oogziekenhuis Rotterdam | |
Rotterdam, Netherlands, 3011 BH | |
Academic Hospital Groningen | |
Groningen, Netherlands, 9700 RB | |
Spain | |
Institut de Microcirurgia Ocular de Barcelona | |
Barcelona, Spain, 08022 | |
Instituto Technologico de Oftalmologia SL. | |
Santiago de Compostela, Spain | |
Hospital Vall D'Hebron | |
Barcelona, Spain, 08035 | |
United Kingdom | |
Moorfields Eye Hospital | |
London, United Kingdom, EC1V 2PD | |
Royal Liverpool & Broadgreen Hospital | |
Liverpool, United Kingdom, L7 8XP |
Principal Investigator: | Anselm Kampik, Prof. Dr. | LMU Augenklinik Munich - Germany |
Responsible Party: | ThromboGenics ( Edith Van Dijkman ) |
Study ID Numbers: | TG-MV-002 |
Study First Received: | December 14, 2006 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00412451 History of Changes |
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 |
Diabetic Macular Edema PVD DME Diabetic Retinopathy |
Signs and Symptoms Macular Edema Diabetic Retinopathy Eye Diseases |
Retinal Degeneration Macular Degeneration Edema Retinal Diseases |
Signs and Symptoms Macular Edema Eye Diseases Retinal Degeneration |
Macular Degeneration Edema Retinal Diseases |