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The Purpose of This Study is to Evaluate the Pharmacokinetic Properties of Intravitreal Ocriplasmin Prior to Planned Primary Pars Plana Vitrectomy (PPV)

2014-07-23 21:08:29 | BioPortfolio

Summary

To evaluate the pharmacokinetic properties of intravitreal ocriplasmin 125 mcg dose when administered at different time-points prior to planned primary pars plana vitrectomy (PPV)

Description

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Primary Pars Plana Vitrectomy

Intervention

ocriplasmin, ocriplasmin, ocriplasmin, ocriplasmin, ocriplasmin

Location

University Hospital Leuven
Leuven
Belgium
B-3000

Status

Recruiting

Source

ThromboGenics

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:29-0400

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