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The purpose of this study is to determine if intravitreal injection of Vitrase (ovine hyaluronidase) clears vitreous hemorrhage
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitrase | Experimental | Single Hyaluronidase ophthalmic intravitreal injection |
|
| Placebo | Placebo Comparator | Single Saline solution intravitreal injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
|
| |
| Vitrase |
| Measure | Description | Time Frame |
|---|---|---|
| Vitreous hemorrhage resolution | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | 12 months | |
| Visual Acuity | 3 months, 6 months and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa R Grillone, PhD | ISTA Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal North Shore Hospital | St Leonards | New South Wales | 2088 | Australia | ||
| University of Sydney |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18441312 | Derived | 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. |
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| Drug |
Hyaluronidase 55 IU in saline solution |
|
|
| Vitrase | Drug | Hyaluronidase 75 IU in saline solution |
|
|
| Sydney |
| New South Wales |
| 2000 |
| Australia |
| University of Sydney/Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Royal Brisbane Hospital | Herston | Queensland | 4029 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Royal Victorian Eye and Ear Hospital | East Melbourne | Victoria | 3002 | Australia |
| Universidade Federal de Goiania | Goiânia | Goiás | 74210-010 | Brazil |
| Universidade Federal de Minas Gerais | Belo Horizonte | Minas Gerais | 30130-270 | Brazil |
| Universidade Federal do Parana | Curitiba | Paraná | 80730-200 | Brazil |
| Universidade Federal do Rio Grande do Sul | Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| Universidade de Sao Paulo | São Paulo | São Paulo | 01525-001 | Brazil |
| Universidade Federal de Sao Paulo, Escola Paulista e Medicina | São Paulo | São Paulo | 04023-062 | Brazil |
| Semmelweiss University | Budapest | H1085 | Hungary |
| Central Army Hospital of the Hungarian Army | Budapest | H1134 | Hungary |
| Uzsoki Street Hospital of the Municipality of Capital | Budapest | H1145 | Hungary |
| Medical University of Debrecen | Debrecen | H4012 | Hungary |
| Medical University of Pecs | Pécs | H7624 | Hungary |
| University of Szeged, Albert Szent-Gyorgyi Medical University | Szeged | H6720 | Hungary |
| Universita degli Studi dell'Aguila | Coppito | I-67100 | Italy |
| Universita degli Studi di Firenze | Florence | I-50134 | Italy |
| Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia | Roma | I-00161 | Italy |
| University of Amsterdam | Amsterdam | AZ | 1105 | Netherlands |
| University Hospital Rotterdam | Rotterdam | Gelderland | 3015 | Netherlands |
| Academic Hospital Groningen | Groningen | GZ | 9713 | Netherlands |
| Klinika Chorob Oczu | Bydgoszcz | 85-168 | Poland |
| Silesian School of Medicine | Bytom | 41-902 | Poland |
| Ophtalmology Clinic | Gdansk | 80-211 | Poland |
| Medical Academy, Lodz | Lodz | 90-153 | Poland |
| Ophthalmology Chair and Clinic | Lublin | 20-079 | Poland |
| Main Regional Hospital | Poznan | 60-479 | Poland |
| K. Marcinkowski University of Medical Sciences | Poznan | 61-841 | Poland |
| Medical Academy, Warsaw | Warsaw | 03-401 | Poland |
| Wroclaw University of Medicine | Wroclaw | 50-368 | Poland |
| Addington Hospital | KwaKhangela | Durban | 4001 | South Africa |
| Joseph J. Krouse, MB, ChB | Alberton | 1449 | South Africa |
| James Acton, MB ChB | Bellville | 7530 | South Africa |
| Nasionale Hospital | Bloemfontein | 9301 | South Africa |
| Newlands Surgical Clinic | Cape Town | 7708 | South Africa |
| Groote Schuur Hospital | Cape Town | 7937 | South Africa |
| Kelvin N. Rivett, MB, ChB | East London | 5201 | South Africa |
| Louis P. Kruger, MB, ChB | Johannesburg | 2195 | South Africa |
| Pretoria Eye Institute | Pretoria | 0002 | South Africa |
| Instituto Oftalmologico de Alicante | Alicante | 03015 | Spain |
| Hospital de la Princesa | Madrid | 28006 | Spain |
| Hospital Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario La Fe | Valencia | 46009 | Spain |
| H. M. Stanley Hospital | St Asaph | Denbighshire | LL17 0RS | United Kingdom |
| Sussex Eye Hospital | Brighton | East Sussex | BN2 5BF | United Kingdom |
| Aberdeen Royal Infirmary | Aberdeen | Scotland | AB25 2ZN | United Kingdom |
| Royal Infirmary of Edinburgh | Edinburgh | Scotland | EH3 9HA | United Kingdom |
| East Surrey Hospital | Redhill | Surrey | RH1 5RH | United Kingdom |
| Bristol Eye Hospital | Bristol | BS1 2LX | United Kingdom |
| Hull Royal Infirmary | Hull | HU3 2JZ | United Kingdom |
| Royal Liverpool University Hospital | Liverpool | L7 8XP | United Kingdom |
| St. Thomas' Hospital | London | SE1 7EH | United Kingdom |
| Kings College Hospital | London | SE5 9RS | United Kingdom |
| Royal Victoria Infirmary | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Oxford Eye Hospital | Oxford | OX2 6HE | United Kingdom |
| ID | Term |
|---|---|
| D014823 | Vitreous Hemorrhage |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D005130 | Eye Hemorrhage |
| D005128 | Eye Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012164 | Retinal Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D002810 | Chondroitinases and Chondroitin Lyases |
| D006821 | Hyaluronoglucosaminidase |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D013429 | Sulfatases |
| D004950 | Esterases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D011133 | Polysaccharide-Lyases |
| D019757 | Carbon-Oxygen Lyases |
| D008190 | Lyases |
| D006026 | Glycoside Hydrolases |
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