NCT01159665

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: ThromboGenics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed 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.

Conditions

• Vitrectomy

Interventions

Type	Name	Description
DRUG	ocriplasmin	125µg ocriplasmin intravitreal injection
DRUG	ocriplasmin	125µg ocriplasmin intravitreal injection
DRUG	ocriplasmin	125µg ocriplasmin intravitreal injection
DRUG	ocriplasmin	125µg ocriplasmin intravitreal injection
DRUG	ocriplasmin	125µg ocriplasmin intravitreal injection

Timeline

• Start date: 2010-07-01
• Primary completion: 2010-11-01
• Completion: 2011-01-01
• First posted: 2010-07-09
• Last updated: 2014-12-17
• Results posted: 2013-01-30

Locations

1 site across 1 country: Belgium