Status:
COMPLETED
A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With Diabetic Macular Edema (DME)
Lead Sponsor:
ThromboGenics
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with DME.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00412451
Start Date
December 1 2006
End Date
March 1 2010
Last Update
December 17 2014
Active Locations (15)
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1
ZNA OCMW Antwerpen
Antwerp, Belgium, 2020
2
University Hospital of Ghent
Ghent, Belgium, B-9000
3
University Hospital Leuven
Leuven, Belgium
4
Ludwig Maximillian University
Munich, Germany