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

Information source: Bausch & Lomb Incorporated
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vitreous Hemorrhage; Diabetic Retinopathy

Intervention: Vitrase (Drug); Vitrase (Drug); Vitrase (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bausch & Lomb Incorporated

Official(s) and/or principal investigator(s):
Lisa R Grillone, PhD, Study Director, Affiliation: ISTA Pharmaceuticals, Inc.

Summary

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

Clinical Details

Official title: Phase III Safety and Efficacy Study of Vitrase (Ovine Hyaluronidase) for Ophthalmic Intravitreal Injection for Clearance of Severe Vitreous Hemorrhage

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Resolution of Vitreous Hemorrhage

Secondary outcome:

Incidence of complications & adverse events

Visual Acuity

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Retina Centers, PC, Tucson, Arizona 85704, United States

Vancouver Eye Care Center/University of British Columbia, Vancouver, British Columbia V5Z 3N9, Canada

Retina Vitreous Associates Medical Group, Beverly Hills, California 90211, United States

Maria E. Castillejos, MD, Chula Vista, California 91910, United States

Eye Medical Center of Fresno, Fresno, California 93721, United States

Natural Vision, Fresno, California 93710, 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

Instituto de Oftalmologia, Fundacion Conde de Valenciana, Col. Obrera, DF 06080, Mexico

Association Para Evitar la Ceguera en Mexico, Coyacan, DF 04030, Mexico

Fundacion Hospital, Nuestra Senora de la Luz IAP, Cuahtemoc, DF 06030, Mexico

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

Dalhousie University, Halifax, Nova Scotia B3H 2Y9, Canada

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

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

Retina Research of Wills Eye Hospital, Philadelphia, Pennsylvania 19107, United States

Scheie Eye Institute, Philadelphia, Pennsylvania 19104, United States

Carim Eye & Retina Center, Wyomissing, Pennsylvania 19606, United States

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

Southeastern Retina Associates, PC, Knoxville, Tennessee 37920, United States

Retina-Vitreous Associates, Nashville, Tennessee 37203, United States

Cullen Eye Institute/Baylor College of Medicine, Houston, Texas 77030, United States

Retinal Vascular Center, Houston, Texas 77002, 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

Additional Information

Starting date: November 1998
Last updated: March 14, 2013

Page last updated: August 23, 2015

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