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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00198510
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 15, 2013
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Description
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Brief Summary:
The purpose of this study is to determine if intravitreal injection of Vitrase (ovine hyaluronidase) clears vitreous hemorrhage

Condition or disease Intervention/treatment Phase
Vitreous Hemorrhage Diabetic Retinopathy Drug: Vitrase Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase III Safety and Efficacy Study of Vitrase (Ovine Hyaluronidase) for Ophthalmic Intravitreal Injection for Clearance of Severe Vitreous Hemorrhage
Study Start Date : November 1998
Actual Primary Completion Date : September 2001
Actual Study Completion Date : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vitrase
A single dose of 0.05 cc of Vitrase (hyaluronidase) for ophthalmic intravitreal injection is injected into the vitreous chamber.
 Drug: Vitrase
7.5 IU of Vitrase
Other Name: ovine hyaluronidase

Drug: Vitrase
55 IU of Vitrase
Other Name: ovine hyaluronidase

Drug: Vitrase
75 IU of Vitrase
Other Name: ovine hyaluronidase
No Intervention: Observation
Observation only, no medication or intravitreal injection


Outcome Measures
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Primary Outcome Measures :
  1. Resolution of Vitreous Hemorrhage [ Time Frame: 3 months ]
    Laser treatment of underlying cause of vitreous hemorrhage, or other surgical treatment, or documented evidence of macula & at least 180 degrees of vitreous base, that vitreous hemorrhage cause is resolved


Secondary Outcome Measures :
  1. Incidence of complications & adverse events [ Time Frame: 12 months ]
  2. Visual Acuity [ Time Frame: 3 months, 6 months, 12 months ]
    Best correct visual acuity (BCVA)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00198510


Locations
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Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
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Study Director: Lisa R Grillone, PhD ISTA Pharmaceuticals, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00198510    
Other Study ID Numbers: VIT-02-08961X
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 15, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Diabetic Retinopathy
Vitreous Hemorrhage
Hemorrhage
Pathologic Processes
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
 Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Eye Hemorrhage