Diabetic Retinopathy Clinical Trial
Official title:
Phase III Safety and Efficacy Study of Vitrase (Ovine Hyaluronidase) for Ophthalmic Intravitreal Injection for Clearance of Severe Vitreous Hemorrhage
| Verified date | March 2013 |
| Source | Bausch & Lomb Incorporated |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to determine if intravitreal injection of Vitrase (ovine hyaluronidase) clears vitreous hemorrhage
| Status | Completed |
| Enrollment | 750 |
| Est. completion date | March 2003 |
| Est. primary completion date | September 2001 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Dalhousie University | Halifax | Nova Scotia |
| Canada | Ivey Institute of Ophthalmology | London | Ontario |
| Canada | Royal Victoria Hospital | Montreal | Quebec |
| Canada | University of Ottawa Eye Institute | Ottawa | Ontario |
| Canada | The Medical Centre Pasqua Hospital | Regina | Saskatchewan |
| Canada | Centre Hospitalier de l'Universite Laval (CHUL) | Sainte-Foy | Quebec |
| Canada | Saskatoon City Hospital | Saskatoon | Saskatchewan |
| Canada | Toronto Western Hospital | Toronto | Ontario |
| Canada | Vancouver Eye Care Center/University of British Columbia | Vancouver | British Columbia |
| Mexico | Instituto de Oftalmologia, Fundacion Conde de Valenciana | Col. Obrera | DF |
| Mexico | Association Para Evitar la Ceguera en Mexico | Coyacan | DF |
| Mexico | Fundacion Hospital, Nuestra Senora de la Luz IAP | Cuahtemoc | DF |
| United States | Retina Center at Pali Momi | Aiea | Hawaii |
| United States | Florida Eye Clinic | Altamonte Springs | Florida |
| United States | Retina Specialists | Baltimore | Maryland |
| United States | Wilmer Eye Institute/Johns Hopkins University School of Medicine | Baltimore | Maryland |
| United States | Retina Consultants, PC | Bethesda | Maryland |
| United States | Retina Vitreous Associates Medical Group | Beverly Hills | California |
| United States | Schepens Retina Associates | Boston | Massachusetts |
| United States | Charlotte Eye, Ear, Nose & Throat Association | Charlotte | North Carolina |
| United States | Illinois Retina Associates SC | Chicago | Illinois |
| United States | University of Chicago | Chicago | Illinois |
| United States | Maria E. Castillejos, MD | Chula Vista | California |
| United States | Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | Retina Associates of Cleveland | Cleveland | Ohio |
| United States | Retina Consultants of Southern Colorado | Colorado Springs | Colorado |
| United States | Retina Consultants, Ohio State University | Columbus | Ohio |
| United States | Danbury Eye Physicians & Surgeons | Danbury | Connecticut |
| United States | University of Colorado Health Sciences Center | Denver | Colorado |
| United States | Eye Centers of Florida | Fort Myers | Florida |
| United States | Eye Medical Center of Fresno | Fresno | California |
| United States | Natural Vision | Fresno | California |
| United States | VitreoRetinal Associates | Grand Rapids | Michigan |
| United States | Long Island Vitreo Retinal Consultants | Great Neck | New York |
| United States | New England Retina Associates | Hamden | Connecticut |
| United States | Cullen Eye Institute/Baylor College of Medicine | Houston | Texas |
| United States | Retinal Vascular Center | Houston | Texas |
| United States | Jerry Sebag, MD | Huntington Beach | California |
| United States | University of California, Irvine | Irvine | California |
| United States | Hunkeler Eye Centers | Kansas City | Missouri |
| United States | Retina Associates of Kansas City | Kansas City | Missouri |
| United States | Southeastern Retina Associates, PC | Knoxville | Tennessee |
| United States | Valley Retina Institute, PA | McAllen | Texas |
| United States | California VitreRetinal Center | Menlo Park | California |
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | Retina Center PA | Minneapolis | Minnesota |
| United States | Retina-Vitreous Associates | Nashville | Tennessee |
| United States | American Eye Institute | New Albany | Indiana |
| United States | Robert Wood Johnson Medical School/Retina Vitreous Center | New Brunswick | New Jersey |
| United States | Kurt A. Gitter, MD | New Orleans | Louisiana |
| United States | Ronni M. Lieberman, MD | New York | New York |
| United States | Dean A. McGee Eye Institute | Oklahoma City | Oklahoma |
| United States | Southern California Desert Retina Consultants | Palm Springs | California |
| United States | Retina Research of Wills Eye Hospital | Philadelphia | Pennsylvania |
| United States | Scheie Eye Institute | Philadelphia | Pennsylvania |
| United States | Felix N. Sabates Eye Associates | Prairie Village | Kansas |
| United States | Carolina Eye Associates, PA | Raleigh | North Carolina |
| United States | Vista Retinal Consultants | Roanoke | Virginia |
| United States | Retinal Consultants | Sacramento | California |
| United States | John Moran Eye Center | Salt Lake City | Utah |
| United States | H. Richard McDonald, MD | San Francisco | California |
| United States | Santa Clara Valley Medical Centre | San Jose | California |
| United States | Robert L. Avery, MD | Santa Barbara | California |
| United States | Sarasota Retina Institute | Sarasota | Florida |
| United States | Virginia Mason Medical Center | Seattle | Washington |
| United States | King Y. Lee, MD | Shawnee Mission | Kansas |
| United States | The Center for Advanced Medicine/Barnes Retina Institute | St. Louis | Missouri |
| United States | Olive View/UCLA Medical Center | Sylmar | California |
| United States | Retina Vitreous Surgeons of Central NY | Syracuse | New York |
| United States | Scott E. Pautler, MD | Tampa | Florida |
| United States | Retina Associates of New Jersey | Teaneck | New Jersey |
| United States | Retina Centers, PC | Tucson | Arizona |
| United States | Carim Eye & Retina Center | Wyomissing | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Bausch & Lomb Incorporated |
United States, Canada, Mexico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | Incidence of complications & adverse events | 12 months | No | |
| Secondary | Visual Acuity | Best correct visual acuity (BCVA) | 3 months, 6 months, 12 months | No |
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