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

March 13, 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

510

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

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

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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vitreous hemorrhage resolution
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
Time Frame
Incidence of adverse events
Time Frame: 12 months
12 months
Visual Acuity
Time Frame: 3 months, 6 months and 12 months
3 months, 6 months and 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

June 1, 1999

Primary Completion (Actual)

September 1, 2001

Study Completion (Actual)

June 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 13, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIT-03-08961X

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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