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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00198510
First received: September 13, 2005
Last updated: March 14, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to determine if intravitreal injection of Vitrase (ovine hyaluronidase) clears vitreous hemorrhage


Condition Intervention Phase
Vitreous Hemorrhage
Diabetic Retinopathy
Drug: Vitrase
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Resolution of Vitreous Hemorrhage [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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:
  • Incidence of complications & adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Visual Acuity [ Time Frame: 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    Best correct visual acuity (BCVA)


Estimated Enrollment: 750
Study Start Date: November 1998
Study Completion Date: March 2003
Primary Completion Date: September 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198510

  Show 73 Study Locations
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Lisa R Grillone, PhD ISTA Pharmaceuticals, Inc.
  More Information

No publications provided by Bausch & Lomb Incorporated

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00198510     History of Changes
Other Study ID Numbers: VIT-02-08961X
Study First Received: September 13, 2005
Last Updated: March 14, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetic Retinopathy
Hemorrhage
Retinal Diseases
Vitreous Hemorrhage
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pathologic Processes
Eye Hemorrhage

ClinicalTrials.gov processed this record on July 26, 2014