Vitrectomy Clinical Trial
Official title:
An Open-Label, Ascending-Exposure-Time, Single Center Trial to Evaluate the Pharmacokinetic Properties of Ocriplasmin (Generic Name of the Molecule Microplasmin) Intravitreal Injection in Subjects Scheduled for Primary Pars Plana Vitrectomy
To evaluate the pharmacokinetic properties of intravitreal ocriplasmin 125 µg dose when administered at different time-points prior to planned primary pars plana vitrectomy (PPV)
Open-label, ascending-exposure-time, single center trial in which a total of 36 subjects
will be enrolled. The time to remove the vitreous will be recorded and a vitreous sample
will be obtained at the beginning of vitrectomy for determination of ocriplasmin activity;
32 subjects will receive 125 μg ocriplasmin intravitreal injection prior to vitrectomy and 4
subjects will not receive ocriplasmin intravitreal injection prior to vitrectomy (control
arm).
Study drug will be administered in the mid-vitreous by injection. The study eye will be
examined after study drug injection to exclude retinal non-perfusion or other complications.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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