A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With Diabetic Macular Edema (DME)

Summary

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

Timeline

Start

2006-12

Primary completion

2010-01

Completion

2010-03

Outcome

Missed primary endpoint

registry The primary efficacy variable was the proportion of patients with total posterior vitreous detachment (PVD) on Day 14 NCT00412451 ↗

registry analysis (superiority or other test); Ocriplasmin 25µg vs Sham Injection; p = 0.131 NCT00412451 ↗

registry analysis (superiority or other test); Ocriplasmin 75µg vs Sham Injection; p = 0.670 NCT00412451 ↗

registry analysis (superiority or other test); Ocriplasmin 125µg vs Sham Injection; p = 0.372 NCT00412451 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
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