Safety and Efficacy Study of Vitrase for Clearance of Severe Vitreous Hemorrhage
Recruiting in Palo Alto (17 mi)
+72 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Bausch & Lomb Incorporated
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The purpose of this study is to determine if intravitreal injection of Vitrase (ovine hyaluronidase) clears vitreous hemorrhage
Eligibility 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
Treatment Details
Interventions
- Vitrase (Hyaluronidase)
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: VitraseExperimental Treatment1 Intervention
A single dose of 0.05 cc of Vitrase (hyaluronidase) for ophthalmic intravitreal injection is injected into the vitreous chamber.
Group II: ObservationActive Control1 Intervention
Observation only, no medication or intravitreal injection
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Long Island Vitreo Retinal ConsultantsGreat Neck, NY
Dalhousie UniversityHalifax, Canada
Toronto Western HospitalToronto, Canada
Florida Eye ClinicAltamonte Springs, FL
More Trial Locations
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Who Is Running the Clinical Trial?
Bausch & Lomb IncorporatedLead Sponsor