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

  Hide Study Locations
Locations
United States, Arizona
Retina Centers, PC
Tucson, Arizona, United States, 85704
United States, California
Retina Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
Maria E. Castillejos, MD
Chula Vista, California, United States, 91910
Eye Medical Center of Fresno
Fresno, California, United States, 93721
Natural Vision
Fresno, California, United States, 93710
Jerry Sebag, MD
Huntington Beach, California, United States, 92647
University of California, Irvine
Irvine, California, United States, 92697
California VitreRetinal Center
Menlo Park, California, United States, 94025
Southern California Desert Retina Consultants
Palm Springs, California, United States, 92262
Retinal Consultants
Sacramento, California, United States, 95819
H. Richard McDonald, MD
San Francisco, California, United States, 94109
Santa Clara Valley Medical Centre
San Jose, California, United States, 95128
Robert L. Avery, MD
Santa Barbara, California, United States, 93103
Olive View/UCLA Medical Center
Sylmar, California, United States, 91342
United States, Colorado
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, United States, 80909
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
United States, Connecticut
Danbury Eye Physicians & Surgeons
Danbury, Connecticut, United States, 06810
New England Retina Associates
Hamden, Connecticut, United States, 06518
United States, Florida
Florida Eye Clinic
Altamonte Springs, Florida, United States, 32701
Eye Centers of Florida
Fort Myers, Florida, United States, 33901
Sarasota Retina Institute
Sarasota, Florida, United States, 34239
Scott E. Pautler, MD
Tampa, Florida, United States, 33614
United States, Hawaii
Retina Center at Pali Momi
Aiea, Hawaii, United States, 96701
United States, Illinois
Illinois Retina Associates SC
Chicago, Illinois, United States, 60612
University of Chicago
Chicago, Illinois, United States, 60637
United States, Indiana
American Eye Institute
New Albany, Indiana, United States, 47150
United States, Kansas
Felix N. Sabates Eye Associates
Prairie Village, Kansas, United States, 66208
King Y. Lee, MD
Shawnee Mission, Kansas, United States, 66202
United States, Louisiana
Kurt A. Gitter, MD
New Orleans, Louisiana, United States, 70115
United States, Maryland
Retina Specialists
Baltimore, Maryland, United States, 21204
Wilmer Eye Institute/Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
Retina Consultants, PC
Bethesda, Maryland, United States, 20817
United States, Massachusetts
Schepens Retina Associates
Boston, Massachusetts, United States, 02215
United States, Michigan
VitreoRetinal Associates
Grand Rapids, Michigan, United States, 49525
United States, Minnesota
Retina Center PA
Minneapolis, Minnesota, United States, 55404
United States, Missouri
Retina Associates of Kansas City
Kansas City, Missouri, United States, 64151
Hunkeler Eye Centers
Kansas City, Missouri, United States, 64111
The Center for Advanced Medicine/Barnes Retina Institute
St. Louis, Missouri, United States, 63110
United States, New Jersey
Robert Wood Johnson Medical School/Retina Vitreous Center
New Brunswick, New Jersey, United States, 08701
Retina Associates of New Jersey
Teaneck, New Jersey, United States, 07666
United States, New York
Long Island Vitreo Retinal Consultants
Great Neck, New York, United States, 11021
Ronni M. Lieberman, MD
New York, New York, United States, 10021
Retina Vitreous Surgeons of Central NY
Syracuse, New York, United States, 13224
United States, North Carolina
Charlotte Eye, Ear, Nose & Throat Association
Charlotte, North Carolina, United States, 28210
Carolina Eye Associates, PA
Raleigh, North Carolina, United States, 27612
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Retina Associates of Cleveland
Cleveland, Ohio, United States, 44195
Retina Consultants, Ohio State University
Columbus, Ohio, United States, 43210
United States, Oklahoma
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Scheie Eye Institute
Philadelphia, Pennsylvania, United States, 19104
Retina Research of Wills Eye Hospital
Philadelphia, Pennsylvania, United States, 19107
Carim Eye & Retina Center
Wyomissing, Pennsylvania, United States, 19606
United States, Tennessee
Southeastern Retina Associates, PC
Knoxville, Tennessee, United States, 37920
Retina-Vitreous Associates
Nashville, Tennessee, United States, 37203
United States, Texas
Cullen Eye Institute/Baylor College of Medicine
Houston, Texas, United States, 77030
Retinal Vascular Center
Houston, Texas, United States, 77002
Valley Retina Institute, PA
McAllen, Texas, United States, 78503
United States, Utah
John Moran Eye Center
Salt Lake City, Utah, United States, 84132
United States, Virginia
Vista Retinal Consultants
Roanoke, Virginia, United States, 24016
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, British Columbia
Vancouver Eye Care Center/University of British Columbia
Vancouver, British Columbia, Canada, V5Z 3N9
Canada, Nova Scotia
Dalhousie University
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Ivey Institute of Ophthalmology
London, Ontario, Canada, N6A 4G5
University of Ottawa Eye Institute
Ottawa, Ontario, Canada, K1H 8L6
Toronto Western Hospital
Toronto, Ontario, Canada, M2P 1E3
Canada, Quebec
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Centre Hospitalier de l'Universite Laval (CHUL)
Sainte-Foy, Quebec, Canada, G1V 4G2
Canada, Saskatchewan
The Medical Centre Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 1A5
Saskatoon City Hospital
Saskatoon, Saskatchewan, Canada, S7K 0M7
Mexico
Instituto de Oftalmologia, Fundacion Conde de Valenciana
Col. Obrera, DF, Mexico, 06080
Association Para Evitar la Ceguera en Mexico
Coyacan, DF, Mexico, 04030
Fundacion Hospital, Nuestra Senora de la Luz IAP
Cuahtemoc, DF, Mexico, 06030
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 August 28, 2014