Safety and Efficacy Study of Vitrase for Clearance of Severe Vitreous Hemorrhage
NCT ID: NCT00198497
Last Updated: 2013-03-15
Study Results
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Basic Information
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COMPLETED
PHASE3
510 participants
INTERVENTIONAL
1999-06-30
2003-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Vitrase
Single Hyaluronidase ophthalmic intravitreal injection
Vitrase
Hyaluronidase 55 IU in saline solution
Vitrase
Hyaluronidase 75 IU in saline solution
Placebo
Single Saline solution intravitreal injection
Placebo
Interventions
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Placebo
Vitrase
Hyaluronidase 55 IU in saline solution
Vitrase
Hyaluronidase 75 IU in saline solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BCVA is worse than 20/200 at time of screening
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Bausch & Lomb Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Lisa R Grillone, PhD
Role: STUDY_DIRECTOR
ISTA Pharmaceuticals, Inc.
Locations
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Royal North Shore Hospital
St Leonards, New South Wales, Australia
University of Sydney
Sydney, New South Wales, Australia
University of Sydney/Westmead Hospital
Westmead, New South Wales, Australia
Royal Brisbane Hospital
Herston, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria, Australia
Universidade Federal de Goiania
Goiânia, Goiás, Brazil
Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
Universidade Federal do Parana
Curitiba, Paraná, Brazil
Universidade Federal do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Universidade de Sao Paulo
São Paulo, São Paulo, Brazil
Universidade Federal de Sao Paulo, Escola Paulista e Medicina
São Paulo, São Paulo, Brazil
Semmelweiss University
Budapest, , Hungary
Central Army Hospital of the Hungarian Army
Budapest, , Hungary
Uzsoki Street Hospital of the Municipality of Capital
Budapest, , Hungary
Medical University of Debrecen
Debrecen, , Hungary
Medical University of Pecs
Pécs, , Hungary
University of Szeged, Albert Szent-Gyorgyi Medical University
Szeged, , Hungary
Universita degli Studi dell'Aguila
Coppito, , Italy
Universita degli Studi di Firenze
Florence, , Italy
Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia
Roma, , Italy
University of Amsterdam
Amsterdam, AZ, Netherlands
University Hospital Rotterdam
Rotterdam, Gelderland, Netherlands
Academic Hospital Groningen
Groningen, GZ, Netherlands
Klinika Chorob Oczu
Bydgoszcz, , Poland
Silesian School of Medicine
Bytom, , Poland
Ophtalmology Clinic
Gdansk, , Poland
Medical Academy, Lodz
Lodz, , Poland
Ophthalmology Chair and Clinic
Lublin, , Poland
Main Regional Hospital
Poznan, , Poland
K. Marcinkowski University of Medical Sciences
Poznan, , Poland
Medical Academy, Warsaw
Warsaw, , Poland
Wroclaw University of Medicine
Wroclaw, , Poland
Addington Hospital
KwaKhangela, Durban, South Africa
Joseph J. Krouse, MB, ChB
Alberton, , South Africa
James Acton, MB ChB
Bellville, , South Africa
Nasionale Hospital
Bloemfontein, , South Africa
Newlands Surgical Clinic
Cape Town, , South Africa
Groote Schuur Hospital
Cape Town, , South Africa
Kelvin N. Rivett, MB, ChB
East London, , South Africa
Louis P. Kruger, MB, ChB
Johannesburg, , South Africa
Pretoria Eye Institute
Pretoria, , South Africa
Instituto Oftalmologico de Alicante
Alicante, , Spain
Hospital de la Princesa
Madrid, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Hospital Universitario La Fe
Valencia, , Spain
H. M. Stanley Hospital
St Asaph, Denbighshire, United Kingdom
Sussex Eye Hospital
Brighton, East Sussex, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Scotland, United Kingdom
East Surrey Hospital
Redhill, Surrey, United Kingdom
Bristol Eye Hospital
Bristol, , United Kingdom
Hull Royal Infirmary
Hull, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
St. Thomas' Hospital
London, , United Kingdom
Kings College Hospital
London, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
Oxford Eye Hospital
Oxford, , United Kingdom
Countries
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References
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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.
Other Identifiers
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VIT-03-08961X
Identifier Type: -
Identifier Source: org_study_id
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