drugset / Trial / NCT00986362

Clinical Trial of Intravitreal Microplasmin in Infants and Children Scheduled for Vitrectomy

NCT00986362 ↗

Phase 2 Completed 24 enrolled ThromboGenics
RandomizedParallel-groupDouble-blindTreatment

Summary

To evaluate the safety and preliminary efficacy of intravitreal microplasmin as an adjunct to conventional vitrectomy for the treatment of pediatric patients.

Timeline

Start
2010-02
Primary completion
2011-12
Completion
2012-04

Outcome

Missed primary endpoint

registry Ocriplasmin vs Placebo; p = 0.679; Odds Ratio (OR) 0.613 (95% CI 0.070 to 4.509); Fisher Exact NCT00986362 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ocriplasmin Protein / enzyme biologic 175 ug Intravitreal

Indications

No indication recorded.