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| Sponsor: | ISTA Pharmaceuticals |
|---|---|
| Information provided by: | ISTA Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00198497 |
Purpose
The purpose of this study is to determine if intravitreal injection of Vitrase (ovine hyaluronidase) clears vitreous hemorrhage
| Condition | Intervention | Phase |
|---|---|---|
|
Vitreous Hemorrhage Diabetic Retinopathy |
Drug: Vitrase (ovine hyaluronidase) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
| Official Title: | Phase III Safety and Efficacy Study of Vitrase (Ovine Hyaluronidase) for Ophthalmic Intravitreal Injection for Clearance of Severe Vitreous Hemorrhage |
| Estimated Enrollment: | 556 |
| Study Start Date: | June 1999 |
| Estimated Study Completion Date: | June 2003 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| Australia, New South Wales | |
| Royal North Shore Hospital | |
| St. Leonards, New South Wales, Australia, 2088 | |
| University of Sydney | |
| Sydney, New South Wales, Australia, 2000 | |
| University of Sydney/Westmead Hospital | |
| Westmead, New South Wales, Australia, 2145 | |
| Australia, Queensland | |
| Royal Brisbane Hospital | |
| Herston, Queensland, Australia, 4029 | |
| Australia, South Australia | |
| Royal Adelaide Hospital | |
| Adelaide, South Australia, Australia, 5000 | |
| Australia, Victoria | |
| Royal Victorian Eye and Ear Hospital | |
| East Melbourne, Victoria, Australia, 3002 | |
| Brazil, Goias | |
| Universidade Federal de Goiania | |
| Goiania, Goias, Brazil, 74210-010 | |
| Brazil, Minas Gerais | |
| Universidade Federal de Minas Gerais | |
| Belo Horizonte, Minas Gerais, Brazil, 30130-270 | |
| Brazil, PR | |
| Universidade Federal do Parana | |
| Curitiba, PR, Brazil, 80730-200 | |
| Brazil, RS | |
| Universidade Federal do Rio Grande do Sul | |
| Porto Alegre, RS, Brazil, 90035-003 | |
| Brazil, SP | |
| Universidade de Sao Paulo | |
| Sao Paulo, SP, Brazil, 01525-001 | |
| Universidade Federal de Sao Paulo, Escola Paulista e Medicina | |
| Sao Paulo, SP, Brazil, 04023-062 | |
| Hungary | |
| Medical University of Debrecen | |
| Debrecen, Hungary, H4012 | |
| Central Army Hospital of the Hungarian Army | |
| Budapest, Hungary, H1134 | |
| University of Szeged, Albert Szent-Gyorgyi Medical University | |
| Szeged, Hungary, H6720 | |
| Medical University of Pecs | |
| Pecs, Hungary, H7624 | |
| Uzsoki Street Hospital of the Municipality of Capital | |
| Budapest, Hungary, H1145 | |
| Semmelweiss University | |
| Budapest, Hungary, H1085 | |
| Italy | |
| Universita degli Studi dell'Aguila | |
| Coppito, Italy, I-67100 | |
| Universita degli Studi di Firenze | |
| Firenze, Italy, I-50134 | |
| Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia | |
| Roma, Italy, I-00161 | |
| Netherlands, AZ | |
| University of Amsterdam | |
| Amsterdam, AZ, Netherlands, 1105 | |
| Netherlands, GD | |
| University Hospital Rotterdam | |
| Rotterdam, GD, Netherlands, 3015 | |
| Netherlands, GZ | |
| Academic Hospital Groningen | |
| Groningen, GZ, Netherlands, 9713 | |
| Poland | |
| Klinika Chorob Oczu | |
| Bydgoszcz, Poland, 85-168 | |
| Medical Academy, Warsaw | |
| Warsaw, Poland, 03-401 | |
| K. Marcinkowski University of Medical Sciences | |
| Poznan, Poland, 61-841 | |
| Wroclaw University of Medicine | |
| Wroclaw, Poland, 50-368 | |
| Medical Academy, Lodz | |
| Lodz, Poland, 90-153 | |
| Main Regional Hospital | |
| Poznan, Poland, 60-479 | |
| Silesian School of Medicine | |
| Bytom, Poland, 41-902 | |
| Ophtalmology Clinic | |
| Gdansk, Poland, 80-211 | |
| Ophthalmology Chair and Clinic | |
| Lublin, Poland, 20-079 | |
| South Africa | |
| Louis P. Kruger, MB, ChB | |
| Johannesburg, South Africa, 2195 | |
| Groote Schuur Hospital | |
| Cape Town, South Africa, 7937 | |
| Joseph J. Krouse, MB, ChB | |
| Alberton, South Africa, 1449 | |
| James Acton, MB ChB | |
| Bellville, South Africa, 7530 | |
| Kelvin N. Rivett, MB, ChB | |
| East London, South Africa, 5201 | |
| Pretoria Eye Institute | |
| Pretoria, South Africa, 0002 | |
| Nasionale Hospital | |
| Bloemfontein, South Africa, 9301 | |
| Newlands Surgical Clinic | |
| Cape Town, South Africa, 7708 | |
| South Africa, Durban | |
| Addington Hospital | |
| Congella, Durban, South Africa, 4001 | |
| Spain | |
| Hospital de la Princesa | |
| Madrid, Spain, 28006 | |
| Hospital Ramon y Cajal | |
| Madrid, Spain, 28034 | |
| Hospital Universitario La Fe | |
| Valencia, Spain, 46009 | |
| Instituto Oftalmologico de Alicante | |
| Alicante, Spain, 03015 | |
| United Kingdom | |
| Bristol Eye Hospital | |
| Bristol, United Kingdom, BS1 2LX | |
| Royal Liverpool University Hospital | |
| Liverpool, United Kingdom, L7 8XP | |
| Royal Victoria Infirmary | |
| Newcastle Upon Tyne, United Kingdom, NE1 4LP | |
| Oxford Eye Hospital | |
| Oxford, United Kingdom, OX2 6HE | |
| Kings College Hospital | |
| London, United Kingdom, SE5 9RS | |
| St. Thomas' Hospital | |
| London, United Kingdom, SE1 7EH | |
| Hull Royal Infirmary | |
| Hull, United Kingdom, HU3 2JZ | |
| United Kingdom, Denbighshire | |
| H. M. Stanley Hospital | |
| St. Asaph, Denbighshire, United Kingdom, LL17 0RS | |
| United Kingdom, East Sussex | |
| Sussex Eye Hospital | |
| Brighton, East Sussex, United Kingdom, BN2 5BF | |
| United Kingdom, Scotland | |
| Aberdeen Royal Infirmary | |
| Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
| Royal Infirmary of Edinburgh | |
| Edinburgh, Scotland, United Kingdom, EH3 9HA | |
| United Kingdom, Surrey | |
| East Surrey Hospital | |
| Redhill, Surrey, United Kingdom, RH1 5RH | |
| Study Director: | Lisa R Grillone, PhD | ISTA Pharmaceuticals, Inc. |
More Information
| Study ID Numbers: | VIT-03-08961X |
| Study First Received: | September 13, 2005 |
| Last Updated: | January 15, 2007 |
| ClinicalTrials.gov Identifier: | NCT00198497 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Eye Diseases Vascular Diseases Diabetes Mellitus Endocrine System Diseases Hemorrhage Vitreous Hemorrhage Diabetic Angiopathies |
Diabetic Retinopathy Pathologic Processes Eye Hemorrhage Cardiovascular Diseases Retinal Diseases Diabetes Complications |
