Trial | NCT00198510  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    750
The purpose of this study is to determine if intravitreal injection of Vitrase (ovine hyaluronidase) clears vitreous hemorrhage
Study Started
Nov 30
1998
Primary Completion
Sep 30
2001
Study Completion
Mar 31
2003
Last Update
Mar 15
2013
Estimate

Drug Vitrase

7.5 IU of Vitrase

  • Other names: ovine hyaluronidase

Drug Vitrase

55 IU of Vitrase

  • Other names: ovine hyaluronidase

Drug Vitrase

75 IU of Vitrase

  • Other names: ovine hyaluronidase

Vitrase Experimental

A single dose of 0.05 cc of Vitrase (hyaluronidase) for ophthalmic intravitreal injection is injected into the vitreous chamber.

Observation No Intervention

Observation only, no medication or intravitreal injection

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
No Results Posted