NCT00198497

Safety and Efficacy Study of Vitrase for Clearance of Severe Vitreous Hemorrhage

Phase III Safety and Efficacy Study of Vitrase (Ovine Hyaluronidase) for Ophthalmic Intravitreal Injection for Clearance of Severe Vitreous Hemorrhage

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 510 (planned)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if intravitreal injection of Vitrase (ovine hyaluronidase) clears vitreous hemorrhage

Conditions

• Vitreous Hemorrhage
• Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	Placebo
DRUG	Vitrase	Hyaluronidase 55 IU in saline solution
DRUG	Vitrase	Hyaluronidase 75 IU in saline solution

Timeline

• Start date: 1999-06-01
• Primary completion: 2001-09-01
• Completion: 2003-06-01
• First posted: 2005-09-20
• Last updated: 2013-03-15

Locations

58 sites across 9 countries: Australia, Brazil, Hungary, Italy, Netherlands, Poland, South Africa, Spain, United Kingdom