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

March 14, 2013 updated by: Bausch & Lomb Incorporated

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

750

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 3N9
        • Vancouver Eye Care Center/University of British Columbia
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Dalhousie University
    • Ontario
      • London, Ontario, Canada, N6A 4G5
        • Ivey Institute of Ophthalmology
      • Ottawa, Ontario, Canada, K1H 8L6
        • University of Ottawa Eye Institute
      • Toronto, Ontario, Canada, M2P 1E3
        • Toronto Western Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • Royal Victoria Hospital
      • Sainte-Foy, Quebec, Canada, G1V 4G2
        • Centre Hospitalier de l'Université Laval (CHUL)
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 1A5
        • The Medical Centre Pasqua Hospital
      • Saskatoon, Saskatchewan, Canada, S7K 0M7
        • Saskatoon City Hospital
  • Mexico
    • DF
      • Col. Obrera, DF, Mexico, 06080
        • Instituto de Oftalmologia, Fundacion Conde de Valenciana
      • Coyacan, DF, Mexico, 04030
        • Association Para Evitar la Ceguera en Mexico
      • Cuahtemoc, DF, Mexico, 06030
        • Fundacion Hospital, Nuestra Senora de la Luz IAP
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Retina Centers, PC
    • California
      • Beverly Hills, California, United States, 90211
        • Retina Vitreous Associates Medical Group
      • Chula Vista, California, United States, 91910
        • Maria E. Castillejos, MD
      • Fresno, California, United States, 93710
        • Natural Vision
      • Fresno, California, United States, 93721
        • Eye Medical Center of Fresno
      • Huntington Beach, California, United States, 92647
        • Jerry Sebag, MD
      • Irvine, California, United States, 92697
        • University of California, Irvine
      • Menlo Park, California, United States, 94025
        • California VitreRetinal Center
      • Palm Springs, California, United States, 92262
        • Southern California Desert Retina Consultants
      • Sacramento, California, United States, 95819
        • Retinal Consultants
      • San Francisco, California, United States, 94109
        • H. Richard McDonald, MD
      • San Jose, California, United States, 95128
        • Santa Clara Valley Medical Centre
      • Santa Barbara, California, United States, 93103
        • Robert L. Avery, MD
      • Sylmar, California, United States, 91342
        • Olive View/Ucla Medical Center
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Retina Consultants of Southern Colorado
      • Denver, Colorado, United States, 80262
        • University of Colorado Health Sciences Center
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Danbury Eye Physicians & Surgeons
      • Hamden, Connecticut, United States, 06518
        • New England Retina Associates
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Florida Eye Clinic
      • Fort Myers, Florida, United States, 33901
        • Eye Centers of Florida
      • Sarasota, Florida, United States, 34239
        • Sarasota Retina Institute
      • Tampa, Florida, United States, 33614
        • Scott E. Pautler, MD
    • Hawaii
      • Aiea, Hawaii, United States, 96701
        • Retina Center at Pali Momi
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States, 60612
        • Illinois Retina Associates SC
    • Indiana
      • New Albany, Indiana, United States, 47150
        • American Eye Institute
    • Kansas
      • Prairie Village, Kansas, United States, 66208
        • Felix N. Sabates Eye Associates
      • Shawnee Mission, Kansas, United States, 66202
        • King Y. Lee, MD
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Kurt A. Gitter, MD
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Retina Specialists
      • Baltimore, Maryland, United States, 21287
        • Wilmer Eye Institute/Johns Hopkins University School of Medicine
      • Bethesda, Maryland, United States, 20817
        • Retina Consultants, PC
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Schepens Retina Associates
    • Michigan
      • Grand Rapids, Michigan, United States, 49525
        • VitreoRetinal Associates
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Retina Center PA
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Hunkeler Eye Centers
      • Kansas City, Missouri, United States, 64151
        • Retina Associates of Kansas City
      • St. Louis, Missouri, United States, 63110
        • The Center for Advanced Medicine/Barnes Retina Institute
    • New Jersey
      • New Brunswick, New Jersey, United States, 08701
        • Robert Wood Johnson Medical School/Retina Vitreous Center
      • Teaneck, New Jersey, United States, 07666
        • Retina Associates of New Jersey
    • New York
      • Great Neck, New York, United States, 11021
        • Long Island Vitreo Retinal Consultants
      • New York, New York, United States, 10021
        • Ronni M. Lieberman, MD
      • Syracuse, New York, United States, 13224
        • Retina Vitreous Surgeons of Central NY
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Charlotte Eye, Ear, Nose & Throat Association
      • Raleigh, North Carolina, United States, 27612
        • Carolina Eye Associates, PA
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44195
        • Retina Associates of Cleveland
      • Columbus, Ohio, United States, 43210
        • Retina Consultants, Ohio State University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Dean A. McGee Eye Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Scheie Eye Institute
      • Philadelphia, Pennsylvania, United States, 19107
        • Retina Research of Wills Eye Hospital
      • Wyomissing, Pennsylvania, United States, 19606
        • Carim Eye & Retina Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Southeastern Retina Associates, PC
      • Nashville, Tennessee, United States, 37203
        • Retina-Vitreous Associates
    • Texas
      • Houston, Texas, United States, 77002
        • Retinal Vascular Center
      • Houston, Texas, United States, 77030
        • Cullen Eye Institute/Baylor College of Medicine
      • McAllen, Texas, United States, 78503
        • Valley Retina Institute, PA
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • John Moran Eye Center
    • Virginia
      • Roanoke, Virginia, United States, 24016
        • Vista Retinal Consultants
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitrase
A single dose of 0.05 cc of Vitrase (hyaluronidase) for ophthalmic intravitreal injection is injected into the vitreous chamber.
Drug: Vitrase
7.5 IU of Vitrase
Other Names:
  • ovine hyaluronidase
Drug: Vitrase
55 IU of Vitrase
Other Names:
  • ovine hyaluronidase
Drug: Vitrase
75 IU of Vitrase
Other Names:
  • ovine hyaluronidase
No Intervention: Observation
Observation only, no medication or intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resolution of Vitreous Hemorrhage
Time Frame: 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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of complications & adverse events
Time Frame: 12 months
12 months
Visual Acuity
Time Frame: 3 months, 6 months, 12 months
Best correct visual acuity (BCVA)
3 months, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb Incorporated

Investigators

  • Study Director: Lisa R Grillone, PhD, ISTA Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1998

Primary Completion (Actual)

September 1, 2001

Study Completion (Actual)

March 1, 2003

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

March 15, 2013

Last Update Submitted That Met QC Criteria

March 14, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIT-02-08961X

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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