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

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT00198497
Collaborator
(none)
510
Enrollment
58
Locations
2
Arms
48
Duration (Months)
8.8
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 :
Jun 1, 1999
Actual Primary Completion Date :
Sep 1, 2001
Actual Study Completion Date :
Jun 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vitrase

Single Hyaluronidase ophthalmic intravitreal injection

Drug: Vitrase
Hyaluronidase 55 IU in saline solution
Other Names:
  • Hyaluronidase

    • Drug: Vitrase
    Hyaluronidase 75 IU in saline solution
    Other Names:
  • Hyaluronidase

    		•
    Placebo Comparator: Placebo

    Single Saline solution intravitreal injection

    Drug: Placebo
    Other Names:
  • Saline solution

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Vitreous hemorrhage resolution [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 adverse events [12 months]

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

    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 Royal North Shore Hospital St. Leonards New South Wales Australia 2088
    2 University of Sydney Sydney New South Wales Australia 2000
    3 University of Sydney/Westmead Hospital Westmead New South Wales Australia 2145
    4 Royal Brisbane Hospital Herston Queensland Australia 4029
    5 Royal Adelaide Hospital Adelaide South Australia Australia 5000
    6 Royal Victorian Eye and Ear Hospital East Melbourne Victoria Australia 3002
    7 Universidade Federal de Goiania Goiania Goias Brazil 74210-010
    8 Universidade Federal de Minas Gerais Belo Horizonte Minas Gerais Brazil 30130-270
    9 Universidade Federal do Parana Curitiba PR Brazil 80730-200
    10 Universidade Federal do Rio Grande do Sul Porto Alegre RS Brazil 90035-003
    11 Universidade de Sao Paulo Sao Paulo SP Brazil 01525-001
    12 Universidade Federal de Sao Paulo, Escola Paulista e Medicina Sao Paulo SP Brazil 04023-062
    13 Semmelweiss University Budapest Hungary H1085
    14 Central Army Hospital of the Hungarian Army Budapest Hungary H1134
    15 Uzsoki Street Hospital of the Municipality of Capital Budapest Hungary H1145
    16 Medical University of Debrecen Debrecen Hungary H4012
    17 Medical University of Pecs Pecs Hungary H7624
    18 University of Szeged, Albert Szent-Gyorgyi Medical University Szeged Hungary H6720
    19 Universita degli Studi dell'Aguila Coppito Italy I-67100
    20 Universita degli Studi di Firenze Firenze Italy I-50134
    21 Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia Roma Italy I-00161
    22 University of Amsterdam Amsterdam AZ Netherlands 1105
    23 University Hospital Rotterdam Rotterdam GD Netherlands 3015
    24 Academic Hospital Groningen Groningen GZ Netherlands 9713
    25 Klinika Chorob Oczu Bydgoszcz Poland 85-168
    26 Silesian School of Medicine Bytom Poland 41-902
    27 Ophtalmology Clinic Gdansk Poland 80-211
    28 Medical Academy, Lodz Lodz Poland 90-153
    29 Ophthalmology Chair and Clinic Lublin Poland 20-079
    30 Main Regional Hospital Poznan Poland 60-479
    31 K. Marcinkowski University of Medical Sciences Poznan Poland 61-841
    32 Medical Academy, Warsaw Warsaw Poland 03-401
    33 Wroclaw University of Medicine Wroclaw Poland 50-368
    34 Addington Hospital Congella Durban South Africa 4001
    35 Joseph J. Krouse, MB, ChB Alberton South Africa 1449
    36 James Acton, MB ChB Bellville South Africa 7530
    37 Nasionale Hospital Bloemfontein South Africa 9301
    38 Newlands Surgical Clinic Cape Town South Africa 7708
    39 Groote Schuur Hospital Cape Town South Africa 7937
    40 Kelvin N. Rivett, MB, ChB East London South Africa 5201
    41 Louis P. Kruger, MB, ChB Johannesburg South Africa 2195
    42 Pretoria Eye Institute Pretoria South Africa 0002
    43 Instituto Oftalmologico de Alicante Alicante Spain 03015
    44 Hospital de la Princesa Madrid Spain 28006
    45 Hospital Ramon y Cajal Madrid Spain 28034
    46 Hospital Universitario La Fe Valencia Spain 46009
    47 H. M. Stanley Hospital St. Asaph Denbighshire United Kingdom LL17 0RS
    48 Sussex Eye Hospital Brighton East Sussex United Kingdom BN2 5BF
    49 Aberdeen Royal Infirmary Aberdeen Scotland United Kingdom AB25 2ZN
    50 Royal Infirmary of Edinburgh Edinburgh Scotland United Kingdom EH3 9HA
    51 East Surrey Hospital Redhill Surrey United Kingdom RH1 5RH
    52 Bristol Eye Hospital Bristol United Kingdom BS1 2LX
    53 Hull Royal Infirmary Hull United Kingdom HU3 2JZ
    54 Royal Liverpool University Hospital Liverpool United Kingdom L7 8XP
    55 St. Thomas' Hospital London United Kingdom SE1 7EH
    56 Kings College Hospital London United Kingdom SE5 9RS
    57 Royal Victoria Infirmary Newcastle Upon Tyne United Kingdom NE1 4LP
    58 Oxford Eye Hospital Oxford United Kingdom OX2 6HE

    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:
    NCT00198497
    Other Study ID Numbers:
    • VIT-03-08961X
    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