Clincosm LogoSign in Get a demo

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

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT00198510
Collaborator
(none)
750
Enrollment
73
Locations
2
Arms
51.9
Duration (Months)
10.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Phase III Safety and Efficacy Study of Vitrase (Ovine Hyaluronidase) for Ophthalmic Intravitreal Injection for Clearance of Severe Vitreous Hemorrhage
Study Start Date :
Nov 1, 1998
Actual Primary Completion Date :
Sep 1, 2001
Actual Study Completion Date :
Mar 1, 2003

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Resolution of Vitreous Hemorrhage [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

    Secondary Outcome Measures

    1. Incidence of complications & adverse events [12 months]

    2. Visual Acuity [3 months, 6 months, 12 months]

      Best correct visual acuity (BCVA)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Bausch & Lomb Incorporated

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bausch & Lomb Incorporated
    ClinicalTrials.gov Identifier:
    NCT00198510
    Other Study ID Numbers:
    • VIT-02-08961X
    First Posted:
    Sep 20, 2005
    Last Update Posted:
    Mar 15, 2013
    Last Verified:
    Mar 1, 2013
    Additional relevant MeSH terms:
    Diabetic Retinopathy
    Vitreous Hemorrhage
    Hemorrhage

    Study Results

    No Results Posted as of Mar 15, 2013