drugset / Trial / NCT00435539

A Study to Compare Multiple Doses Intravitreal Microplasmin for Treatment of Patients With Vitreomacular Traction (MIVI-IIt)

NCT00435539 ↗

Phase 2 Completed 60 enrolled ThromboGenics
RandomizedParallel-groupDouble-blindTreatment

Summary

A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with vitreomacular traction.

Timeline

Start
2007-02
Primary completion
2009-01
Completion
2009-02

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Ocriplasmin 75µg Single Injection vs Sham Injection; p = 0.4762; Fisher Exact NCT00435539 ↗

registry analysis (superiority or other test); Ocriplasmin 175µg Single Injection vs Sham Injection; p = 0.4762; Fisher Exact NCT00435539 ↗

registry analysis (superiority or other test); Ocriplasmin 125µg Pooled vs Sham Injection; p = 0.5343; Fisher Exact NCT00435539 ↗

Drugs

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

Indications