Safety and Efficacy Study of Vitrase for Clearance of Severe Vitreous Hemorrhage
- Registration Number
- NCT00198510
- Lead Sponsor
- Bausch & Lomb Incorporated
- Brief Summary
The purpose of this study is to determine if intravitreal injection of Vitrase (ovine hyaluronidase) clears vitreous hemorrhage
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 750
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vitrase Vitrase A single dose of 0.05 cc of Vitrase (hyaluronidase) for ophthalmic intravitreal injection is injected into the vitreous chamber.
- Primary Outcome Measures
Name Time Method Resolution of Vitreous Hemorrhage 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
Name Time Method Incidence of complications & adverse events 12 months Visual Acuity 3 months, 6 months, 12 months Best correct visual acuity (BCVA)
Trial Locations
- Locations (73)
Illinois Retina Associates SC
🇺🇸Chicago, Illinois, United States
Retina Center at Pali Momi
🇺🇸Aiea, Hawaii, United States
King Y. Lee, MD
🇺🇸Shawnee Mission, Kansas, United States
Retina Consultants of Southern Colorado
🇺🇸Colorado Springs, Colorado, United States
H. Richard McDonald, MD
🇺🇸San Francisco, California, United States
Schepens Retina Associates
🇺🇸Boston, Massachusetts, United States
Retina Associates of Cleveland
🇺🇸Cleveland, Ohio, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Wilmer Eye Institute/Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
Retina Center PA
🇺🇸Minneapolis, Minnesota, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Retinal Vascular Center
🇺🇸Houston, Texas, United States
Robert Wood Johnson Medical School/Retina Vitreous Center
🇺🇸New Brunswick, New Jersey, United States
Felix N. Sabates Eye Associates
🇺🇸Prairie Village, Kansas, United States
Eye Centers of Florida
🇺🇸Fort Myers, Florida, United States
The Center for Advanced Medicine/Barnes Retina Institute
🇺🇸St. Louis, Missouri, United States
VitreoRetinal Associates
🇺🇸Grand Rapids, Michigan, United States
Sarasota Retina Institute
🇺🇸Sarasota, Florida, United States
Retina Specialists
🇺🇸Baltimore, Maryland, United States
Long Island Vitreo Retinal Consultants
🇺🇸Great Neck, New York, United States
Florida Eye Clinic
🇺🇸Altamonte Springs, Florida, United States
Carolina Eye Associates, PA
🇺🇸Raleigh, North Carolina, United States
American Eye Institute
🇺🇸New Albany, Indiana, United States
Retina Associates of New Jersey
🇺🇸Teaneck, New Jersey, United States
Charlotte Eye, Ear, Nose & Throat Association
🇺🇸Charlotte, North Carolina, United States
University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
Dean A. McGee Eye Institute
🇺🇸Oklahoma City, Oklahoma, United States
Scott E. Pautler, MD
🇺🇸Tampa, Florida, United States
Retina Consultants, PC
🇺🇸Bethesda, Maryland, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Cullen Eye Institute/Baylor College of Medicine
🇺🇸Houston, Texas, United States
Retina Vitreous Surgeons of Central NY
🇺🇸Syracuse, New York, United States
Scheie Eye Institute
🇺🇸Philadelphia, Pennsylvania, United States
Valley Retina Institute, PA
🇺🇸McAllen, Texas, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Retina Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
Maria E. Castillejos, MD
🇺🇸Chula Vista, California, United States
Retina Centers, PC
🇺🇸Tucson, Arizona, United States
Eye Medical Center of Fresno
🇺🇸Fresno, California, United States
Southern California Desert Retina Consultants
🇺🇸Palm Springs, California, United States
Natural Vision
🇺🇸Fresno, California, United States
Jerry Sebag, MD
🇺🇸Huntington Beach, California, United States
California VitreRetinal Center
🇺🇸Menlo Park, California, United States
University of California, Irvine
🇺🇸Irvine, California, United States
Robert L. Avery, MD
🇺🇸Santa Barbara, California, United States
Santa Clara Valley Medical Centre
🇺🇸San Jose, California, United States
Danbury Eye Physicians & Surgeons
🇺🇸Danbury, Connecticut, United States
Olive View/UCLA Medical Center
🇺🇸Sylmar, California, United States
Ronni M. Lieberman, MD
🇺🇸New York, New York, United States
New England Retina Associates
🇺🇸Hamden, Connecticut, United States
Retina Research of Wills Eye Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Retina Consultants, Ohio State University
🇺🇸Columbus, Ohio, United States
Carim Eye & Retina Center
🇺🇸Wyomissing, Pennsylvania, United States
Retina-Vitreous Associates
🇺🇸Nashville, Tennessee, United States
Southeastern Retina Associates, PC
🇺🇸Knoxville, Tennessee, United States
John Moran Eye Center
🇺🇸Salt Lake City, Utah, United States
Vista Retinal Consultants
🇺🇸Roanoke, Virginia, United States
Vancouver Eye Care Center/University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Ivey Institute of Ophthalmology
🇨🇦London, Ontario, Canada
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
The Medical Centre Pasqua Hospital
🇨🇦Regina, Saskatchewan, Canada
Instituto de Oftalmologia, Fundacion Conde de Valenciana
🇲🇽Col. Obrera, DF, Mexico
Royal Victoria Hospital
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier de l'Universite Laval (CHUL)
🇨🇦Sainte-Foy, Quebec, Canada
University of Ottawa Eye Institute
🇨🇦Ottawa, Ontario, Canada
Fundacion Hospital, Nuestra Senora de la Luz IAP
🇲🇽Cuahtemoc, DF, Mexico
Saskatoon City Hospital
🇨🇦Saskatoon, Saskatchewan, Canada
Dalhousie University
🇨🇦Halifax, Nova Scotia, Canada
Association Para Evitar la Ceguera en Mexico
🇲🇽Coyacan, DF, Mexico
Retinal Consultants
🇺🇸Sacramento, California, United States
Hunkeler Eye Centers
🇺🇸Kansas City, Missouri, United States
Kurt A. Gitter, MD
🇺🇸New Orleans, Louisiana, United States
Retina Associates of Kansas City
🇺🇸Kansas City, Missouri, United States