Macular Degeneration Clinical Trial
— COBALTOfficial 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).
| Verified date | September 2014 |
| Source | OPKO Health, Inc. |
| 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 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.
| Status | Terminated |
| Enrollment | 338 |
| Est. completion date | May 2009 |
| Est. primary completion date | March 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years and older |
| Eligibility |
Inclusion Criteria: 1. Patients must be age 50 years or older 2. Patients must have predominantly classic, minimally classic or occult with no classic lesions secondary to Age Related Macular Degeneration. 3. The study eye must have ETDRS best corrected visual acuity of 69 to 24 letters (20/40 to 20/320 Snellen equivalent). 4. Patients must be willing and able to return for scheduled monthly follow-up visits for two-years. Exclusion Criteria: 1. Prior pharmacologic treatment for AMD in the study (patients can not have previously received Avastin®/Lucentis®, Macugen®, or any other anti-VEGF agents, steroid treatments, PDT, radiation treatment, or any experimental therapies for AMD in the study eye) 2. Any intraocular surgery of the study eye within 12 weeks of screening 3. Previous posterior vitrectomy of the study eye 4. Advanced glaucoma or intraocular pressure above 22 mm Hg in the study eye despite treatment. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Calgary Retina Consultants (site 318) | Calgary | Alberta |
| Canada | Ivey Eye Institute (site 314) | London | Ontario |
| Canada | Canadian Centre for Advanced Eye Therapeutics (site 291) | Mississauga | Ontario |
| Canada | Eye Centre Pasqua Hospital (site 299) | Regina | Saskatchewan |
| Canada | Sunnybrook Health Sciences Centre (site 305) | Toronto | Ontario |
| United States | Retina Research Institute of Texas, L.L.C. (site 269) | Abilene | Texas |
| United States | Capital Region Retina (site 316) | Albany | New York |
| United States | Florida Eye Clinic (site 257) | Altamonte Springs | Florida |
| United States | Retina and Vitreous Center of Southern Oregon (site 271) | Ashland | Oregon |
| United States | Southeast Retina Center (site 268) | Augusta | Georgia |
| United States | Austin Retina Associates (site 304) | Austin | Texas |
| United States | Retina Research Center (site 204) | Austin | Texas |
| United States | Ophthalmology Associates of PA (site 297) | Bala Cynwyd | Pennsylvania |
| United States | Retina Associates of Cleveland (site 228) | Beachwood | Ohio |
| United States | Florida Eye Microsurgical Institute, Inc. (site 217) | Boynton Beach | Florida |
| United States | University of Virginia- Ophthalmology Dept. (site 254) | Charlottesville | Virginia |
| United States | Cincinnati Eye Institute (site 285) | Cincinnati | Ohio |
| United States | Retina Associates St. Louis (site 300) | Florissant | Missouri |
| United States | National Ophthalmic Research Institute at Retina Consultants of SW Florida (site 270) | Fort Myers | Florida |
| United States | Retina Health Center (site 247) | Fort Myers | Florida |
| United States | Eye Medical Center (site 287) | Fresno | California |
| United States | University of Texas Medical Branch- Galveston (site 301 | Galveston | Texas |
| United States | Houston Eye Associates (site 321) | Houston | Texas |
| United States | Midwest Eye Institute (site 253) | Indianapolis | Indiana |
| United States | Eye Foundation of Kansas City Truman Medical Center (site 272) | Kansas City | Missouri |
| United States | Southeastern Retina Associates, PC (Site 250) | Knoxville | Tennessee |
| United States | Retina Associates of Cleveland, Inc. (site 219) | Lakewood | Ohio |
| United States | Retinal Consultants of Nevada (site 273) | Las Vegas | Nevada |
| United States | Delaware Valley Retina Associates (site 261) | Lawrenceville | New Jersey |
| United States | Retina-Vitreous Consultants (site 216) | Livingston | New Jersey |
| United States | Eye Centers of Louisville (site 251) | Louisville | Kentucky |
| United States | Valley Retina Institue, PA (site 258) | McAllen | Texas |
| United States | Northern California Retina Vitreous Associates (site 320) | Mountain View | California |
| United States | New York Eye & Ear Infirmary (site 272) | New York | New York |
| United States | Vitreous-Retina-Macula Consultants of New York (site 239) | New York | New York |
| United States | Magruder Eye Institute (site 264) | Orlando | Florida |
| United States | Retina Institute of California (site 207) | Pasadena | California |
| United States | Associated Retina Consultants (site 286) | Phoenix | Arizona |
| United States | Retinal Consultants of Arizona (site 209) | Phoenix | Arizona |
| United States | Eyesight Ophthalmic Services, PA (site 290) | Portsmouth | New Hampshire |
| United States | Retina Consultants San Diego (site 232) | Poway | California |
| United States | Black Hills Regional Eye Institute (site 202) | Rapid City | South Dakota |
| United States | Retinal Consultants Medical Group (site 289) | Sacramento | California |
| United States | Rocky Mountain Retina Consultants (site 256) | Salt Lake City | Utah |
| United States | University of Utah, John A. Moran Eye Center (site 205) | Salt Lake City | Utah |
| United States | Orange County Retina Medical Group (site 252) | Santa Ana | California |
| United States | Retina Associates, PA (site 295) | Shawnee Mission | Kansas |
| United States | Carolina Eye Associates (site 308) | Southern Pines | North Carolina |
| United States | Southern Vitreoretinal Associates, PL (site 309) | Tallahassee | Florida |
| United States | University of South Florida Eye Institute (site 311) | Tampa | Florida |
| United States | Retina Associates of New Jersey (site 298) | Teaneck | New Jersey |
| United States | Retina-Vitreous Associates (site 266) | Toledo | Ohio |
| United States | Retina Specialists (site 231) | Towson | Maryland |
| United States | Retina Centers PC (site 215) | Tucson | Arizona |
| United States | Eye Care Associates of East Texas (site 282) | Tyler | Texas |
| United States | Miramar Eye Specialists Medical Group (site 245) | Ventura | California |
| United States | The Eye Care Group, PC (site 315) | Waterbury | Connecticut |
| United States | Palmetto Retina Center (site 275) | West Columbia | South Carolina |
| United States | Vitreo-Retinal Consultants & Surgeons, P.A. (site 274) | Wichita | Kansas |
| United States | Center for Retina and Macular Disease (site 293) | Winter Haven | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| OPKO Health, Inc. |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Visual Acuity | avoidance of 3 or more lines of vision loss | week 60 | No |
| Secondary | Need for Rescue Therapy, Time to Rescue Therapy, and Number of Patients With a 3 or More Line Gain in Vision | Week 60 | No |
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