NCT00123279

Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy

A Dose-escalation Clinical Trial of Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy for Vitreomacular Traction Maculopathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: ThromboGenics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Vitreomacular Traction Maculopathy
• Eye Diseases

Interventions

Type	Name	Description
DRUG	Microplasmin	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.

Timeline

• Start date: 2004-12-01
• Primary completion: 2007-02-01
• Completion: 2008-11-01
• First posted: 2005-07-22
• Last updated: 2014-04-07

Locations

3 sites across 2 countries: Belgium, Netherlands