Safety and Efficacy Study of Vitrase for Clearance of Severe Vitreous Hemorrhage
Phase III Safety and Efficacy Study of Vitrase (Ovine Hyaluronidase) for Ophthalmic Intravitreal Injection for Clearance of Severe Vitreous Hemorrhage
1 other identifier
interventional
750
3 countries
73
Brief Summary
The purpose of this study is to determine if intravitreal injection of Vitrase (ovine hyaluronidase) clears vitreous hemorrhage
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 1998
Typical duration for phase_3
73 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 1998
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedMarch 15, 2013
March 1, 2013
2.8 years
September 13, 2005
March 14, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Resolution of Vitreous Hemorrhage
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
3 months
Secondary Outcomes (2)
Incidence of complications & adverse events
12 months
Visual Acuity
3 months, 6 months, 12 months
Study Arms (2)
Vitrase
EXPERIMENTALA single dose of 0.05 cc of Vitrase (hyaluronidase) for ophthalmic intravitreal injection is injected into the vitreous chamber.
Observation
NO INTERVENTIONObservation only, no medication or intravitreal injection
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (73)
Retina Centers, PC
Tucson, Arizona, 85704, United States
Retina Vitreous Associates Medical Group
Beverly Hills, California, 90211, United States
Maria E. Castillejos, MD
Chula Vista, California, 91910, United States
Natural Vision
Fresno, California, 93710, United States
Eye Medical Center of Fresno
Fresno, California, 93721, United States
Jerry Sebag, MD
Huntington Beach, California, 92647, United States
University of California, Irvine
Irvine, California, 92697, United States
California VitreRetinal Center
Menlo Park, California, 94025, United States
Southern California Desert Retina Consultants
Palm Springs, California, 92262, United States
Retinal Consultants
Sacramento, California, 95819, United States
H. Richard McDonald, MD
San Francisco, California, 94109, United States
Santa Clara Valley Medical Centre
San Jose, California, 95128, United States
Robert L. Avery, MD
Santa Barbara, California, 93103, United States
Olive View/UCLA Medical Center
Sylmar, California, 91342, United States
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, 80909, United States
University of Colorado Health Sciences Center
Denver, Colorado, 80262, United States
Danbury Eye Physicians & Surgeons
Danbury, Connecticut, 06810, United States
New England Retina Associates
Hamden, Connecticut, 06518, United States
Florida Eye Clinic
Altamonte Springs, Florida, 32701, United States
Eye Centers of Florida
Fort Myers, Florida, 33901, United States
Sarasota Retina Institute
Sarasota, Florida, 34239, United States
Scott E. Pautler, MD
Tampa, Florida, 33614, United States
Retina Center at Pali Momi
‘Aiea, Hawaii, 96701, United States
Illinois Retina Associates SC
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
American Eye Institute
New Albany, Indiana, 47150, United States
Felix N. Sabates Eye Associates
Prairie Village, Kansas, 66208, United States
King Y. Lee, MD
Shawnee Mission, Kansas, 66202, United States
Kurt A. Gitter, MD
New Orleans, Louisiana, 70115, United States
Retina Specialists
Baltimore, Maryland, 21204, United States
Wilmer Eye Institute/Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287, United States
Retina Consultants, PC
Bethesda, Maryland, 20817, United States
Schepens Retina Associates
Boston, Massachusetts, 02215, United States
VitreoRetinal Associates
Grand Rapids, Michigan, 49525, United States
Retina Center PA
Minneapolis, Minnesota, 55404, United States
Hunkeler Eye Centers
Kansas City, Missouri, 64111, United States
Retina Associates of Kansas City
Kansas City, Missouri, 64151, United States
The Center for Advanced Medicine/Barnes Retina Institute
St Louis, Missouri, 63110, United States
Robert Wood Johnson Medical School/Retina Vitreous Center
New Brunswick, New Jersey, 08701, United States
Retina Associates of New Jersey
Teaneck, New Jersey, 07666, United States
Long Island Vitreo Retinal Consultants
Great Neck, New York, 11021, United States
Ronni M. Lieberman, MD
New York, New York, 10021, United States
Retina Vitreous Surgeons of Central NY
Syracuse, New York, 13224, United States
Charlotte Eye, Ear, Nose & Throat Association
Charlotte, North Carolina, 28210, United States
Carolina Eye Associates, PA
Raleigh, North Carolina, 27612, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Retina Associates of Cleveland
Cleveland, Ohio, 44195, United States
Retina Consultants, Ohio State University
Columbus, Ohio, 43210, United States
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, 73104, United States
Scheie Eye Institute
Philadelphia, Pennsylvania, 19104, United States
Retina Research of Wills Eye Hospital
Philadelphia, Pennsylvania, 19107, United States
Carim Eye & Retina Center
Wyomissing, Pennsylvania, 19606, United States
Southeastern Retina Associates, PC
Knoxville, Tennessee, 37920, United States
Retina-Vitreous Associates
Nashville, Tennessee, 37203, United States
Retinal Vascular Center
Houston, Texas, 77002, United States
Cullen Eye Institute/Baylor College of Medicine
Houston, Texas, 77030, United States
Valley Retina Institute, PA
McAllen, Texas, 78503, United States
John Moran Eye Center
Salt Lake City, Utah, 84132, United States
Vista Retinal Consultants
Roanoke, Virginia, 24016, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Vancouver Eye Care Center/University of British Columbia
Vancouver, British Columbia, V5Z 3N9, Canada
Dalhousie University
Halifax, Nova Scotia, B3H 2Y9, Canada
Ivey Institute of Ophthalmology
London, Ontario, N6A 4G5, Canada
University of Ottawa Eye Institute
Ottawa, Ontario, K1H 8L6, Canada
Toronto Western Hospital
Toronto, Ontario, M2P 1E3, Canada
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1, Canada
Centre Hospitalier de l'Universite Laval (CHUL)
Sainte-Foy, Quebec, G1V 4G2, Canada
The Medical Centre Pasqua Hospital
Regina, Saskatchewan, S4T 1A5, Canada
Saskatoon City Hospital
Saskatoon, Saskatchewan, S7K 0M7, Canada
Instituto de Oftalmologia, Fundacion Conde de Valenciana
Col. Obrera, Mexico City, 06080, Mexico
Association Para Evitar la Ceguera en Mexico
Coyacan, Mexico City, 04030, Mexico
Fundacion Hospital, Nuestra Senora de la Luz IAP
Cuahtemoc, Mexico City, 06030, Mexico
Related Publications (1)
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.
PMID: 18441312DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lisa R Grillone, PhD
ISTA Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 20, 2005
Study Start
November 1, 1998
Primary Completion
September 1, 2001
Study Completion
March 1, 2003
Last Updated
March 15, 2013
Record last verified: 2013-03