The purpose of this trial is to evaluate the safety and preliminary efficacy of different doses and several exposure times of intravitreal microplasmin in the setting of pars plana vitrectomy for vitreomacular traction maculopathy.
Study drug will be administered in the mid-vitreous by injection. Patients will be enrolled into the cohorts in a sequential dose/time-escalating fashion. To ensure that enrolment is evenly balanced across eligible conditions, enrolment of any specific underlying disease type into any cohort will be capped at five (5) patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
25ug injected 1 hr prior to PPV, 24 hr and 7 days prior to PPV, 50ug injected 24 hr prior to PPV, 75ug injected 24 hr prior to PPV and 125ug injected 24 hr prior to PPV.
University Hospital Gasthuisberg
Leuven, Belgium
Academic Medical Center, University of Amsterdam
Amsterdam, Netherlands
Oogziekenhuis Rotterdam
Rotterdam, Netherlands
Grade of Posterior Vitreous Detachment (PVD) preoperatively and release of vitreomacular traction
Time frame: Baseline, 1,2 and 3hr, 1, 3, 14, 28, 90 and 180 Days
The occurrence of any (serious) adverse event
Time frame: Throught-out the study
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