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| Sponsor: | Opko Health, Inc. |
|---|---|
| Information provided by: | Opko Health, Inc. |
| ClinicalTrials.gov Identifier: | NCT00499590 |
Purpose
The purpose of this study is to compare the safety and effectiveness of bevasiranib given either every 8 weeks or every 12 weeks after an initial pre-treatment with 3 injections of Lucentis® (ranibizumab injection) compared to Lucentis® given every 4 weeks to people with wet AMD. Patients will be assigned at random (like tossing a coin) to receive one of three treatments options for 104 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Macular Degeneration |
Drug: bevasiranib Drug: ranibizumab |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 3, Randomized, Double-Masked, Parallel-Assignment Study of Intravitreal Bevasiranib Sodium, Administered Every 8 or 12 Weeks as Maintenance Therapy Following Three Injections of Lucentis® Compared With Lucentis® Monotherapy Every 4 Weeks in Patients With Exudative Age-Related Macular Degeneration (AMD). |
| Estimated Enrollment: | 330 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Active Comparator
Lucentis® (0.5mg) every 4 weeks.
|
Drug: ranibizumab
Lucentis® (0.5 mg)administered intravitreally every 4 weeks.
|
|
B: Experimental
Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.
|
Drug: bevasiranib
Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks
|
|
C: Experimental
Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.
|
Drug: bevasiranib
Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Retina Centers PC (site 215) | |
| Tucson, Arizona, United States, 85704 | |
| Associated Retina Consultants (site 286) | |
| Phoenix, Arizona, United States, 85020 | |
| Retinal Consultants of Arizona (site 209) | |
| Phoenix, Arizona, United States, 85014 | |
| United States, California | |
| Miramar Eye Specialists Medical Group (site 245) | |
| Ventura, California, United States, 93003 | |
| Orange County Retina Medical Group (site 252) | |
| Santa Ana, California, United States, 92705 | |
| Eye Medical Center (site 287) | |
| Fresno, California, United States, 93720 | |
| Retina Consultants San Diego (site 232) | |
| Poway, California, United States, 93064 | |
| Retinal Consultants Medical Group (site 289) | |
| Sacramento, California, United States, 95819 | |
| Retina Institute of California (site 207) | |
| Pasadena, California, United States, 91105 | |
| Northern California Retina Vitreous Associates (site 320) | |
| Mountain View, California, United States, 94040 | |
| United States, Connecticut | |
| The Eye Care Group, PC (site 315) | |
| Waterbury, Connecticut, United States, 06708 | |
| United States, Florida | |
| National Ophthalmic Research Institute at Retina Consultants of SW Florida (site 270) | |
| Fort Myers, Florida, United States, 33912 | |
| Magruder Eye Institute (site 264) | |
| Orlando, Florida, United States, 32803 | |
| Florida Eye Clinic (site 257) | |
| Altamonte Springs, Florida, United States, 32701 | |
| Florida Eye Microsurgical Institute, Inc. (site 217) | |
| Boynton Beach, Florida, United States, 33426 | |
| Retina Health Center (site 247) | |
| Fort Myers, Florida, United States, 33901 | |
| Center for Retina and Macular Disease (site 293) | |
| Winter Haven, Florida, United States, 33880 | |
| University of South Florida Eye Institute (site 311) | |
| Tampa, Florida, United States, 33612 | |
| Southern Vitreoretinal Associates, PL (site 309) | |
| Tallahassee, Florida, United States, 32308 | |
| United States, Georgia | |
| Southeast Retina Center (site 268) | |
| Augusta, Georgia, United States, 30909 | |
| United States, Indiana | |
| Midwest Eye Institute (site 253) | |
| Indianapolis, Indiana, United States, 46280 | |
| United States, Kansas | |
| Vitreo-Retinal Consultants & Surgeons, P.A. (site 274) | |
| Wichita, Kansas, United States, 67214 | |
| Retina Associates, PA (site 295) | |
| Shawnee Mission, Kansas, United States, 66204 | |
| United States, Kentucky | |
| Eye Centers of Louisville (site 251) | |
| Louisville, Kentucky, United States, 40207 | |
| United States, Maryland | |
| Retina Specialists (site 231) | |
| Towson, Maryland, United States, 21204 | |
| United States, Missouri | |
| Eye Foundation of Kansas City Truman Medical Center (site 272) | |
| Kansas City, Missouri, United States, 64108 | |
| Retina Associates St. Louis (site 300) | |
| Florissant, Missouri, United States, 63031 | |
| United States, Nevada | |
| Retinal Consultants of Nevada (site 273) | |
| Las Vegas, Nevada, United States, 89144 | |
| United States, New Hampshire | |
| Eyesight Ophthalmic Services, PA (site 290) | |
| Portsmouth, New Hampshire, United States, 03801 | |
| United States, New Jersey | |
| Delaware Valley Retina Associates (site 261) | |
| Lawrenceville, New Jersey, United States, 08648 | |
| Retina-Vitreous Consultants (site 216) | |
| Livingston, New Jersey, United States, 07039 | |
| Retina Associates of New Jersey (site 298) | |
| Teaneck, New Jersey, United States, 07666 | |
| United States, New York | |
| New York Eye & Ear Infirmary (site 272) | |
| New York, New York, United States, 10003 | |
| Vitreous-Retina-Macula Consultants of New York (site 239) | |
| New York, New York, United States, 10022 | |
| Capital Region Retina (site 316) | |
| Albany, New York, United States, 12206 | |
| United States, North Carolina | |
| Carolina Eye Associates (site 308) | |
| Southern Pines, North Carolina, United States, 28387 | |
| United States, Ohio | |
| Retina Associates of Cleveland, Inc. (site 219) | |
| Lakewood, Ohio, United States, 44107 | |
| Retina Associates of Cleveland (site 228) | |
| Beachwood, Ohio, United States, 44122 | |
| Cincinnati Eye Institute (site 285) | |
| Cincinnati, Ohio, United States, 45242 | |
| Retina-Vitreous Associates (site 266) | |
| Toledo, Ohio, United States, 43608 | |
| United States, Oregon | |
| Retina and Vitreous Center of Southern Oregon (site 271) | |
| Ashland, Oregon, United States, 97520 | |
| United States, Pennsylvania | |
| Ophthalmology Associates of PA (site 297) | |
| Bala Cynwyd, Pennsylvania, United States, 19004 | |
| United States, South Carolina | |
| Palmetto Retina Center (site 275) | |
| West Columbia, South Carolina, United States, 29169 | |
| United States, South Dakota | |
| Black Hills Regional Eye Institute (site 202) | |
| Rapid City, South Dakota, United States, 57701 | |
| United States, Tennessee | |
| Southeastern Retina Associates, PC (Site 250) | |
| Knoxville, Tennessee, United States, 37909 | |
| United States, Texas | |
| Retina Research Center (site 204) | |
| Austin, Texas, United States, 78705 | |
| Valley Retina Institue, PA (site 258) | |
| McAllen, Texas, United States, 78503 | |
| Retina Research Institute of Texas, L.L.C. (site 269) | |
| Abilene, Texas, United States, 79606 | |
| Eye Care Associates of East Texas (site 282) | |
| Tyler, Texas, United States, 75701 | |
| Austin Retina Associates (site 304) | |
| Austin, Texas, United States, 78705 | |
| Houston Eye Associates (site 321) | |
| Houston, Texas, United States, 77025 | |
| University of Texas Medical Branch- Galveston (site 301 | |
| Galveston, Texas, United States, 77555 | |
| United States, Utah | |
| Rocky Mountain Retina Consultants (site 256) | |
| Salt Lake City, Utah, United States, 84107 | |
| University of Utah, John A. Moran Eye Center (site 205) | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Virginia | |
| University of Virginia- Ophthalmology Dept. (site 254) | |
| Charlottesville, Virginia, United States, 22908 | |
| Canada, Alberta | |
| Calgary Retina Consultants (site 318) | |
| Calgary, Alberta, Canada, T3E 7M8 | |
| Canada, Ontario | |
| Canadian Centre for Advanced Eye Therapeutics (site 291) | |
| Mississauga, Ontario, Canada, L4W 1W9 | |
| Ivey Eye Institute (site 314) | |
| London, Ontario, Canada, N6A 4G5 | |
| Sunnybrook Health Sciences Centre (site 305) | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Canada, Saskatchewan | |
| Eye Centre Pasqua Hospital (site 299) | |
| Regina, Saskatchewan, Canada, S4T 1A5 | |
| Study Director: | Denis O'Shaughnessy, Ph.D. | Senior VP of Clincial Development |
More Information
| Responsible Party: | Opko Health ( Denis O'Shaughnessy, PhD Senior VP Clinical Development ) |
| Study ID Numbers: | ACU301 |
| Study First Received: | July 10, 2007 |
| Last Updated: | March 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00499590 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
AMD Macular Degeneration bevasiranib COBALT study |
age related macular degeneration wet AMD wet age related macular degeneration |
|
Eye Diseases Retinal Degeneration Macular Degeneration Retinal Diseases |
