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

• Status: Completed
• Trial end date: 2003-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch & Lomb Incorporated
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Severe vitreous hemorrhage that obscures visualization of the fundus on indirect ophthalmoscopy, that has been present >/= 1 month by history or exam

• BCVA is worse than 20/200 at time of screening

Exclusion Criteria:

• Corneal or lenticular abnormalities that preclude fundus observation

• Ongoing ocular infection, inflammation or history of herpetic corneal lesion

• Current or prior retinal detachment or retinal tears or breaks or intraocular tumor

• More than 1 severe vitreous hemorrhage within 6 months

• Previous vitrectomy for any reason

• Hemorrhage is exclusively pre-retinal, or old & organized

• Prior Vitrase for intravitreal injection in either eye

• No light perception in either eye at any time

• Known contraindications to study medication

• Sickle cell disease