Safety and Efficacy Study of Vitrase for Clearance of Severe Vitreous Hemorrhage
NCT ID: NCT00198510
Last Updated: 2013-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
750 participants
INTERVENTIONAL
1998-11-30
2003-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Vitrase
A single dose of 0.05 cc of Vitrase (hyaluronidase) for ophthalmic intravitreal injection is injected into the vitreous chamber.
Vitrase
7.5 IU of Vitrase
Vitrase
55 IU of Vitrase
Vitrase
75 IU of Vitrase
Observation
Observation only, no medication or intravitreal injection
No interventions assigned to this group
Interventions
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Vitrase
7.5 IU of Vitrase
Vitrase
55 IU of Vitrase
Vitrase
75 IU of Vitrase
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BCVA is worse than 20/200 at time of screening
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Bausch & Lomb Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Lisa R Grillone, PhD
Role: STUDY_DIRECTOR
ISTA Pharmaceuticals, Inc.
Locations
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Retina Centers, PC
Tucson, Arizona, United States
Retina Vitreous Associates Medical Group
Beverly Hills, California, United States
Maria E. Castillejos, MD
Chula Vista, California, United States
Natural Vision
Fresno, California, United States
Eye Medical Center of Fresno
Fresno, California, United States
Jerry Sebag, MD
Huntington Beach, California, United States
University of California, Irvine
Irvine, California, United States
California VitreRetinal Center
Menlo Park, California, United States
Southern California Desert Retina Consultants
Palm Springs, California, United States
Retinal Consultants
Sacramento, California, United States
H. Richard McDonald, MD
San Francisco, California, United States
Santa Clara Valley Medical Centre
San Jose, California, United States
Robert L. Avery, MD
Santa Barbara, California, United States
Olive View/UCLA Medical Center
Sylmar, California, United States
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, United States
University of Colorado Health Sciences Center
Denver, Colorado, United States
Danbury Eye Physicians & Surgeons
Danbury, Connecticut, United States
New England Retina Associates
Hamden, Connecticut, United States
Florida Eye Clinic
Altamonte Springs, Florida, United States
Eye Centers of Florida
Fort Myers, Florida, United States
Sarasota Retina Institute
Sarasota, Florida, United States
Scott E. Pautler, MD
Tampa, Florida, United States
Retina Center at Pali Momi
‘Aiea, Hawaii, United States
Illinois Retina Associates SC
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
American Eye Institute
New Albany, Indiana, United States
Felix N. Sabates Eye Associates
Prairie Village, Kansas, United States
King Y. Lee, MD
Shawnee Mission, Kansas, United States
Kurt A. Gitter, MD
New Orleans, Louisiana, United States
Retina Specialists
Baltimore, Maryland, United States
Wilmer Eye Institute/Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Retina Consultants, PC
Bethesda, Maryland, United States
Schepens Retina Associates
Boston, Massachusetts, United States
VitreoRetinal Associates
Grand Rapids, Michigan, United States
Retina Center PA
Minneapolis, Minnesota, United States
Hunkeler Eye Centers
Kansas City, Missouri, United States
Retina Associates of Kansas City
Kansas City, Missouri, United States
The Center for Advanced Medicine/Barnes Retina Institute
St Louis, Missouri, United States
Robert Wood Johnson Medical School/Retina Vitreous Center
New Brunswick, New Jersey, United States
Retina Associates of New Jersey
Teaneck, New Jersey, United States
Long Island Vitreo Retinal Consultants
Great Neck, New York, United States
Ronni M. Lieberman, MD
New York, New York, United States
Retina Vitreous Surgeons of Central NY
Syracuse, New York, United States
Charlotte Eye, Ear, Nose & Throat Association
Charlotte, North Carolina, United States
Carolina Eye Associates, PA
Raleigh, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Retina Associates of Cleveland
Cleveland, Ohio, United States
Retina Consultants, Ohio State University
Columbus, Ohio, United States
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, United States
Scheie Eye Institute
Philadelphia, Pennsylvania, United States
Retina Research of Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Carim Eye & Retina Center
Wyomissing, Pennsylvania, United States
Southeastern Retina Associates, PC
Knoxville, Tennessee, United States
Retina-Vitreous Associates
Nashville, Tennessee, United States
Retinal Vascular Center
Houston, Texas, United States
Cullen Eye Institute/Baylor College of Medicine
Houston, Texas, United States
Valley Retina Institute, PA
McAllen, Texas, United States
John Moran Eye Center
Salt Lake City, Utah, United States
Vista Retinal Consultants
Roanoke, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Vancouver Eye Care Center/University of British Columbia
Vancouver, British Columbia, Canada
Dalhousie University
Halifax, Nova Scotia, Canada
Ivey Institute of Ophthalmology
London, Ontario, Canada
University of Ottawa Eye Institute
Ottawa, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
Centre Hospitalier de l'Universite Laval (CHUL)
Sainte-Foy, Quebec, Canada
The Medical Centre Pasqua Hospital
Regina, Saskatchewan, Canada
Saskatoon City Hospital
Saskatoon, Saskatchewan, Canada
Instituto de Oftalmologia, Fundacion Conde de Valenciana
Col. Obrera, Mexico City, Mexico
Association Para Evitar la Ceguera en Mexico
Coyacan, Mexico City, Mexico
Fundacion Hospital, Nuestra Senora de la Luz IAP
Cuahtemoc, Mexico City, Mexico
Countries
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References
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Bhavsar AR, Grillone LR, McNamara TR, Gow JA, Hochberg AM, Pearson RK; Vitrase for Vitreous Hemorrhage Study Groups. Predicting response of vitreous hemorrhage after intravitreous injection of highly purified ovine hyaluronidase (Vitrase) in patients with diabetes. Invest Ophthalmol Vis Sci. 2008 Oct;49(10):4219-25. doi: 10.1167/iovs.07-1602. Epub 2008 Apr 25.
Other Identifiers
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VIT-02-08961X
Identifier Type: -
Identifier Source: org_study_id
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