Clinical trial NCT00198510: Safety and Efficacy Study of Vitrase for Clearance of Severe Vitreous Hemorrhage
Official title: Phase III Safety and Efficacy Study of Vitrase (Ovine Hyaluronidase) for Ophthalmic Intravitreal Injection for Clearance of Severe Vitreous Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vitreous Hemorrhage
Diabetic Retinopathy
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Resolution of Vitreous Hemorrhage
timeFrame: 3 months
Secondary outcomes:
measure: Incidence of complications & adverse events
timeFrame: 12 months
measure: Visual Acuity
timeFrame: 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Retina Centers, PC
state: Arizona
city: Beverly Hills
country: United States
facility: Retina Vitreous Associates Medical Group
state: California
city: Chula Vista
country: United States
facility: Maria E. Castillejos, MD
state: California
city: Fresno
country: United States
facility: Natural Vision
state: California
city: Fresno
country: United States
facility: Eye Medical Center of Fresno
state: California
city: Huntington Beach
country: United States
facility: Jerry Sebag, MD
state: California
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Menlo Park
country: United States
facility: California VitreRetinal Center
state: California
city: Palm Springs
country: United States
facility: Southern California Desert Retina Consultants
state: California
city: Sacramento
country: United States
facility: Retinal Consultants
state: California
city: San Francisco
country: United States
facility: H. Richard McDonald, MD
state: California
city: San Jose
country: United States
facility: Santa Clara Valley Medical Centre
state: California
city: Santa Barbara
country: United States
facility: Robert L. Avery, MD
state: California
city: Sylmar
country: United States
facility: Olive View/UCLA Medical Center
state: California
city: Colorado Springs
country: United States
facility: Retina Consultants of Southern Colorado
state: Colorado
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Danbury
country: United States
facility: Danbury Eye Physicians & Surgeons
state: Connecticut
city: Hamden
country: United States
facility: New England Retina Associates
state: Connecticut
city: Altamonte Springs
country: United States
facility: Florida Eye Clinic
state: Florida
city: Fort Myers
country: United States
facility: Eye Centers of Florida
state: Florida
city: Sarasota
country: United States
facility: Sarasota Retina Institute
state: Florida
city: Tampa
country: United States
facility: Scott E. Pautler, MD
state: Florida
city: Aiea
country: United States
facility: Retina Center at Pali Momi
state: Hawaii
city: Chicago
country: United States
facility: Illinois Retina Associates SC
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: New Albany
country: United States
facility: American Eye Institute
state: Indiana
city: Prairie Village
country: United States
facility: Felix N. Sabates Eye Associates
state: Kansas
city: Shawnee Mission
country: United States
facility: King Y. Lee, MD
state: Kansas
city: New Orleans
country: United States
facility: Kurt A. Gitter, MD
state: Louisiana
city: Baltimore
country: United States
facility: Retina Specialists
state: Maryland
city: Baltimore
country: United States
facility: Wilmer Eye Institute/Johns Hopkins University School of Medicine
state: Maryland
city: Bethesda
country: United States
facility: Retina Consultants, PC
state: Maryland
city: Boston
country: United States
facility: Schepens Retina Associates
state: Massachusetts
city: Grand Rapids
country: United States
facility: VitreoRetinal Associates
state: Michigan
city: Minneapolis
country: United States
facility: Retina Center PA
state: Minnesota
city: Kansas City
country: United States
facility: Hunkeler Eye Centers
state: Missouri
city: Kansas City
country: United States
facility: Retina Associates of Kansas City
state: Missouri
city: St. Louis
country: United States
facility: The Center for Advanced Medicine/Barnes Retina Institute
state: Missouri
city: New Brunswick
country: United States
facility: Robert Wood Johnson Medical School/Retina Vitreous Center
state: New Jersey
city: Teaneck
country: United States
facility: Retina Associates of New Jersey
state: New Jersey
city: Great Neck
country: United States
facility: Long Island Vitreo Retinal Consultants
state: New York
city: New York
country: United States
facility: Ronni M. Lieberman, MD
state: New York
city: Syracuse
country: United States
facility: Retina Vitreous Surgeons of Central NY
state: New York
city: Charlotte
country: United States
facility: Charlotte Eye, Ear, Nose & Throat Association
state: North Carolina
city: Raleigh
country: United States
facility: Carolina Eye Associates, PA
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Cleveland
country: United States
facility: Retina Associates of Cleveland
state: Ohio
city: Columbus
country: United States
facility: Retina Consultants, Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: Dean A. McGee Eye Institute
state: Oklahoma
city: Philadelphia
country: United States
facility: Scheie Eye Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Retina Research of Wills Eye Hospital
state: Pennsylvania
city: Wyomissing
country: United States
facility: Carim Eye & Retina Center
state: Pennsylvania
city: Knoxville
country: United States
facility: Southeastern Retina Associates, PC
state: Tennessee
city: Nashville
country: United States
facility: Retina-Vitreous Associates
state: Tennessee
city: Houston
country: United States
facility: Retinal Vascular Center
state: Texas
city: Houston
country: United States
facility: Cullen Eye Institute/Baylor College of Medicine
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute, PA
state: Texas
city: Salt Lake City
country: United States
facility: John Moran Eye Center
state: Utah
city: Roanoke
country: United States
facility: Vista Retinal Consultants
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Vancouver
country: Canada
facility: Vancouver Eye Care Center/University of British Columbia
state: British Columbia
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
city: London
country: Canada
facility: Ivey Institute of Ophthalmology
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Eye Institute
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Sainte-Foy
country: Canada
facility: Centre Hospitalier de l'Universite Laval (CHUL)
state: Quebec
city: Regina
country: Canada
facility: The Medical Centre Pasqua Hospital
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Saskatoon City Hospital
state: Saskatchewan
city: Col. Obrera
country: Mexico
facility: Instituto de Oftalmologia, Fundacion Conde de Valenciana
state: DF
city: Coyacan
country: Mexico
facility: Association Para Evitar la Ceguera en Mexico
state: DF
city: Cuahtemoc
country: Mexico
facility: Fundacion Hospital, Nuestra Senora de la Luz IAP
state: DF
Study officials:
affiliation: ISTA Pharmaceuticals, Inc.
name: Lisa R Grillone, PhD
role: STUDY_DIRECTOR
References:
citation: 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.