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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. Identifier: NCT00198497
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 15, 2013
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

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: Placebo Drug: Vitrase Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 510 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 : June 1999
Actual Primary Completion Date : September 2001
Actual Study Completion Date : June 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Vitrase
Single Hyaluronidase ophthalmic intravitreal injection
Drug: Vitrase
Hyaluronidase 55 IU in saline solution
Other Name: Hyaluronidase

Drug: Vitrase
Hyaluronidase 75 IU in saline solution
Other Name: Hyaluronidase

Placebo Comparator: Placebo
Single Saline solution intravitreal injection
Drug: Placebo
Other Name: Saline solution

Primary Outcome Measures :
  1. Vitreous hemorrhage resolution [ 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 adverse events [ Time Frame: 12 months ]
  2. Visual Acuity [ Time Frame: 3 months, 6 months and 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00198497

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Sponsors and Collaborators
Bausch & Lomb Incorporated
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Study Director: Lisa R Grillone, PhD ISTA Pharmaceuticals, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bausch & Lomb Incorporated Identifier: NCT00198497    
Other Study ID Numbers: VIT-03-08961X
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
Pathologic Processes
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Eye Hemorrhage