A Multicenter, Randomized, Placebo-Controlled, Double-Masked, Parallel Group, Dose-Ranging Clinical Trial of Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy: The MIVI III (Microplasmin For Vitreous Injection III) Trial

NCT00412958 Phase 2 COMPLETED Results posted

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

Details

Lead sponsor	ThromboGenics
Phase	Phase 2
Status	COMPLETED
Enrolment	125
Start date	2006-12
Completion	2008-10

Conditions

• Vitrectomy

Interventions

• Ocriplasmin 25µg
• Ocriplasmin 75µg
• Ocriplasmin 125µg
• Placebo

Primary outcomes

• Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect — Day 7
  The primary efficacy endpoint was the proportion of patients achieving total PVD without creation of an anatomical defect (ie, retinal hole, retinal detachment) based on surgeon visualization at the beginning of vitrectomy prior to suction or any other mechanical intervention.

Countries

United States