Status:
COMPLETED
Safety and Efficacy Study of Vitrase for Clearance of Severe Vitreous Hemorrhage
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Vitreous Hemorrhage
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if intravitreal injection of Vitrase (ovine hyaluronidase) clears vitreous hemorrhage
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 1999
Trial Type :
INTERVENTIONAL
End Date :
June 1 2003
Estimated Enrollment :
510 Patients enrolled
Trial Details
Trial ID
NCT00198497
Start Date
June 1 1999
End Date
June 1 2003
Last Update
March 15 2013
Active Locations (58)
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1
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2088
2
University of Sydney
Sydney, New South Wales, Australia, 2000
3
University of Sydney/Westmead Hospital
Westmead, New South Wales, Australia, 2145
4
Royal Brisbane Hospital
Herston, Queensland, Australia, 4029