Overview

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

Status:
Completed
Trial end date:
2003-03-01
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
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