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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 | A single dose of 0.05 cc of Vitrase (hyaluronidase) for ophthalmic intravitreal injection is injected into the vitreous chamber. |
|
| Observation | No Intervention | Observation only, no medication or intravitreal injection |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitrase | Drug | 7.5 IU of Vitrase |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of Vitreous Hemorrhage | 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 complications & adverse events | 12 months | |
| Visual Acuity | Best correct visual acuity (BCVA) | 3 months, 6 months, 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 |
|---|---|---|---|---|---|---|
| Retina Centers, PC | Tucson | Arizona | 85704 | United States | ||
| Retina Vitreous Associates Medical Group |
| 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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| Vitrase | Drug | 55 IU of Vitrase |
|
|
| Vitrase | Drug | 75 IU of Vitrase |
|
|
| Beverly Hills |
| California |
| 90211 |
| United States |
| Maria E. Castillejos, MD | Chula Vista | California | 91910 | United States |
| Natural Vision | Fresno | California | 93710 | United States |
| Eye Medical Center of Fresno | Fresno | California | 93721 | United States |
| Jerry Sebag, MD | Huntington Beach | California | 92647 | United States |
| University of California, Irvine | Irvine | California | 92697 | United States |
| California VitreRetinal Center | Menlo Park | California | 94025 | United States |
| Southern California Desert Retina Consultants | Palm Springs | California | 92262 | United States |
| Retinal Consultants | Sacramento | California | 95819 | United States |
| H. Richard McDonald, MD | San Francisco | California | 94109 | United States |
| Santa Clara Valley Medical Centre | San Jose | California | 95128 | United States |
| Robert L. Avery, MD | Santa Barbara | California | 93103 | United States |
| Olive View/UCLA Medical Center | Sylmar | California | 91342 | United States |
| Retina Consultants of Southern Colorado | Colorado Springs | Colorado | 80909 | United States |
| University of Colorado Health Sciences Center | Denver | Colorado | 80262 | United States |
| Danbury Eye Physicians & Surgeons | Danbury | Connecticut | 06810 | United States |
| New England Retina Associates | Hamden | Connecticut | 06518 | United States |
| Florida Eye Clinic | Altamonte Springs | Florida | 32701 | United States |
| Eye Centers of Florida | Fort Myers | Florida | 33901 | United States |
| Sarasota Retina Institute | Sarasota | Florida | 34239 | United States |
| Scott E. Pautler, MD | Tampa | Florida | 33614 | United States |
| Retina Center at Pali Momi | ‘Aiea | Hawaii | 96701 | United States |
| Illinois Retina Associates SC | Chicago | Illinois | 60612 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| American Eye Institute | New Albany | Indiana | 47150 | United States |
| Felix N. Sabates Eye Associates | Prairie Village | Kansas | 66208 | United States |
| King Y. Lee, MD | Shawnee Mission | Kansas | 66202 | United States |
| Kurt A. Gitter, MD | New Orleans | Louisiana | 70115 | United States |
| Retina Specialists | Baltimore | Maryland | 21204 | United States |
| Wilmer Eye Institute/Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287 | United States |
| Retina Consultants, PC | Bethesda | Maryland | 20817 | United States |
| Schepens Retina Associates | Boston | Massachusetts | 02215 | United States |
| VitreoRetinal Associates | Grand Rapids | Michigan | 49525 | United States |
| Retina Center PA | Minneapolis | Minnesota | 55404 | United States |
| Hunkeler Eye Centers | Kansas City | Missouri | 64111 | United States |
| Retina Associates of Kansas City | Kansas City | Missouri | 64151 | United States |
| The Center for Advanced Medicine/Barnes Retina Institute | St Louis | Missouri | 63110 | United States |
| Robert Wood Johnson Medical School/Retina Vitreous Center | New Brunswick | New Jersey | 08701 | United States |
| Retina Associates of New Jersey | Teaneck | New Jersey | 07666 | United States |
| Long Island Vitreo Retinal Consultants | Great Neck | New York | 11021 | United States |
| Ronni M. Lieberman, MD | New York | New York | 10021 | United States |
| Retina Vitreous Surgeons of Central NY | Syracuse | New York | 13224 | United States |
| Charlotte Eye, Ear, Nose & Throat Association | Charlotte | North Carolina | 28210 | United States |
| Carolina Eye Associates, PA | Raleigh | North Carolina | 27612 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Retina Associates of Cleveland | Cleveland | Ohio | 44195 | United States |
| Retina Consultants, Ohio State University | Columbus | Ohio | 43210 | United States |
| Dean A. McGee Eye Institute | Oklahoma City | Oklahoma | 73104 | United States |
| Scheie Eye Institute | Philadelphia | Pennsylvania | 19104 | United States |
| Retina Research of Wills Eye Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Carim Eye & Retina Center | Wyomissing | Pennsylvania | 19606 | United States |
| Southeastern Retina Associates, PC | Knoxville | Tennessee | 37920 | United States |
| Retina-Vitreous Associates | Nashville | Tennessee | 37203 | United States |
| Retinal Vascular Center | Houston | Texas | 77002 | United States |
| Cullen Eye Institute/Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Valley Retina Institute, PA | McAllen | Texas | 78503 | United States |
| John Moran Eye Center | Salt Lake City | Utah | 84132 | United States |
| Vista Retinal Consultants | Roanoke | Virginia | 24016 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Vancouver Eye Care Center/University of British Columbia | Vancouver | British Columbia | V5Z 3N9 | Canada |
| Dalhousie University | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Ivey Institute of Ophthalmology | London | Ontario | N6A 4G5 | Canada |
| University of Ottawa Eye Institute | Ottawa | Ontario | K1H 8L6 | Canada |
| Toronto Western Hospital | Toronto | Ontario | M2P 1E3 | Canada |
| Royal Victoria Hospital | Montreal | Quebec | H3A 1A1 | Canada |
| Centre Hospitalier de l'Universite Laval (CHUL) | Sainte-Foy | Quebec | G1V 4G2 | Canada |
| The Medical Centre Pasqua Hospital | Regina | Saskatchewan | S4T 1A5 | Canada |
| Saskatoon City Hospital | Saskatoon | Saskatchewan | S7K 0M7 | Canada |
| Instituto de Oftalmologia, Fundacion Conde de Valenciana | Col. Obrera | Mexico City | 06080 | Mexico |
| Association Para Evitar la Ceguera en Mexico | Coyacan | Mexico City | 04030 | Mexico |
| Fundacion Hospital, Nuestra Senora de la Luz IAP | Cuahtemoc | Mexico City | 06030 | Mexico |
| 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 |
|---|---|
| D002810 | Chondroitinases and Chondroitin Lyases |
| ID | Term |
|---|---|
| D013429 | Sulfatases |
| D004950 | Esterases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D011133 | Polysaccharide-Lyases |
| D019757 | Carbon-Oxygen Lyases |
| D008190 | Lyases |
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