A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with vitreomacular traction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Intravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin.
Intravitreal injection of ocriplasmin solution containing 125µg of ocriplasmin with up to 2 additional (open label) 125µg ocriplasmin injection at 1 month interval.
Intravitreal sham injection
ZNA OCMW Antwerpen
Antwerp, Belgium
University Hospital of Ghent
Ghent, Belgium
Universitaire Ziekenhuizen K.U.Leuven
Leuven, Belgium
Augenklinik der Universitat Munchen
München, Germany
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.
Time frame: Day 14
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.
Time frame: Day 28
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