A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With Diabetic Macular Edema (DME)
- Registration Number
- NCT00412451
- Lead Sponsor
- ThromboGenics
- Brief Summary
A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with DME.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ocriplasmin 25µg ocriplasmin 25µg ocriplasmin intravitreal injection versus sham injection Ocriplasmin 75µg ocriplasmin 75µg ocriplasmin intravitreal injection versus sham injection sham injection Sham injection Sham injection Ocriplasmin 125µg ocriplasmin 125µg ocriplasmin intravitreal injection versus sham injection
- Primary Outcome Measures
Name Time Method PVD Induction 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
ZNA OCMW Antwerpen
🇧🇪Antwerpen, Belgium
University Hospital of Ghent
🇧🇪Ghent, Belgium
University Hospital Leuven
🇧🇪Leuven, Belgium
Ludwig Maximillian University
🇩🇪Munich, Germany
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
Ospedale di Circolo di Varese, Insubria University
🇮🇹Varese, Italy
Academic Hospital Groningen
🇳🇱Groningen, Netherlands
Het Oogziekenhuis Rotterdam
🇳🇱Rotterdam, Netherlands
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