Vitreomacular Traction Clinical Trial
Official title:
A Randomized, Sham-Injection Controlled, Double-Masked, Ascending-Dose, Dose-Range-Finding Trial of Microplasmin Intravitreal Injection for Non-Surgical Posterior Vitreous Detachment (PVD) Induction for Treatment of Vitreomacular Traction (VMT).
A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with vitreomacular traction.
Status | Completed |
Enrollment | 60 |
Est. completion date | February 2009 |
Est. primary completion date | January 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients >_ 18 years of age with vitreomacular traction Exclusion Criteria: - PVD present at baseline - Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR) - Vitreous hemorrhage - Patients who have had a vitrectomy in the study eye at any time |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | ZNA OCMW Antwerpen | Antwerpen | |
Belgium | University Hospital of Ghent | Ghent | |
Belgium | Universitaire Ziekenhuizen K.U.Leuven | Leuven | |
Germany | Augenklinik der Universitat Munchen | Munchen |
Lead Sponsor | Collaborator |
---|---|
ThromboGenics |
Belgium, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Subjects With Total PVD at the First Day 14 Post-injection Visit (Vitreous Detachment to the Equator) as Determined by Masked Central Reading Center (CRC) Evaluation of B-scan Imaging. | Day 14 | No | |
Secondary | Resolution of Vitreomacular Traction (Investigator's Assessment) | Resolution of VMT was evaluated by the investigator using optical coherence tomography (OCT).Resolution of VMT was defined as a change from baseline status of Yes to post-injection status of No and was evaluated by the investigator using OCT. Subjects undergoing vitrectomy had their last observation prior to vitrectomy carried forward. | Day 28 | No |
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