drugset / Trial / NCT00412958

A Study of the Safety and Efficacy of Microplasmin to Induce a Posterior Vitreous Detachment (MIVI III)

NCT00412958 ↗

Phase 2 Completed 125 enrolled ThromboGenics
RandomizedParallel-groupDouble-blindTreatment

Summary

A multicenter study to compare multiple doses of intravitreal microplasmin in patients undergoing surgical vitrectomy.

Timeline

Start
2006-12
Primary completion
2008-10
Completion
2008-10

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Ocriplasmin 25µg vs Placebo; p = 0.796; NCT00412958 ↗

registry analysis (superiority or other test); Ocriplasmin 75µg vs Placebo; p = 0.447; NCT00412958 ↗

registry analysis (superiority or other test); Ocriplasmin 125µg vs Placebo; p = 0.107; NCT00412958 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ocriplasmin Protein / enzyme biologic 25 ug Intravitreal
Subject Ocriplasmin Protein / enzyme biologic 75 ug Intravitreal
Subject Ocriplasmin Protein / enzyme biologic 125 ug Intravitreal

Indications

No indication recorded.