Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD
- Registration Number
- NCT00499590
- Lead Sponsor
- OPKO Health, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 338
- Patients must be age 50 years or older
- Patients must have predominantly classic, minimally classic or occult with no classic lesions secondary to Age Related Macular Degeneration.
- The study eye must have ETDRS best corrected visual acuity of 69 to 24 letters (20/40 to 20/320 Snellen equivalent).
- Patients must be willing and able to return for scheduled monthly follow-up visits for two-years.
- 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)
- Any intraocular surgery of the study eye within 12 weeks of screening
- Previous posterior vitrectomy of the study eye
- Advanced glaucoma or intraocular pressure above 22 mm Hg in the study eye despite treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description C bevasiranib 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. A ranibizumab Lucentis® (0.5mg) every 4 weeks. B bevasiranib 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.
- Primary Outcome Measures
Name Time Method Visual Acuity week 60 avoidance of 3 or more lines of vision loss
- Secondary Outcome Measures
Name Time Method Need for Rescue Therapy, Time to Rescue Therapy, and Number of Patients With a 3 or More Line Gain in Vision Week 60
Trial Locations
- Locations (60)
Retina Institute of California (site 207)
🇺🇸Pasadena, California, United States
Miramar Eye Specialists Medical Group (site 245)
🇺🇸Ventura, California, United States
Florida Eye Microsurgical Institute, Inc. (site 217)
🇺🇸Boynton Beach, Florida, United States
Eye Medical Center (site 287)
🇺🇸Fresno, California, United States
Retina Health Center (site 247)
🇺🇸Fort Myers, Florida, United States
National Ophthalmic Research Institute at Retina Consultants of SW Florida (site 270)
🇺🇸Fort Myers, Florida, United States
Retina Consultants San Diego (site 232)
🇺🇸Poway, California, United States
The Eye Care Group, PC (site 315)
🇺🇸Waterbury, Connecticut, United States
Retinal Consultants Medical Group (site 289)
🇺🇸Sacramento, California, United States
Orange County Retina Medical Group (site 252)
🇺🇸Santa Ana, California, United States
Florida Eye Clinic (site 257)
🇺🇸Altamonte Springs, Florida, United States
Northern California Retina Vitreous Associates (site 320)
🇺🇸Mountain View, California, United States
Sunnybrook Health Sciences Centre (site 305)
🇨🇦Toronto, Ontario, Canada
Retina Specialists (site 231)
🇺🇸Towson, Maryland, United States
Retina Research Institute of Texas, L.L.C. (site 269)
🇺🇸Abilene, Texas, United States
Southeast Retina Center (site 268)
🇺🇸Augusta, Georgia, United States
Capital Region Retina (site 316)
🇺🇸Albany, New York, United States
Eye Foundation of Kansas City Truman Medical Center (site 272)
🇺🇸Kansas City, Missouri, United States
Retina Associates St. Louis (site 300)
🇺🇸Florissant, Missouri, United States
Retina-Vitreous Consultants (site 216)
🇺🇸Livingston, New Jersey, United States
Austin Retina Associates (site 304)
🇺🇸Austin, Texas, United States
Carolina Eye Associates (site 308)
🇺🇸Southern Pines, North Carolina, United States
Eyesight Ophthalmic Services, PA (site 290)
🇺🇸Portsmouth, New Hampshire, United States
Delaware Valley Retina Associates (site 261)
🇺🇸Lawrenceville, New Jersey, United States
Retina Associates of Cleveland, Inc. (site 219)
🇺🇸Lakewood, Ohio, United States
Retina-Vitreous Associates (site 266)
🇺🇸Toledo, Ohio, United States
New York Eye & Ear Infirmary (site 272)
🇺🇸New York, New York, United States
Vitreo-Retinal Consultants & Surgeons, P.A. (site 274)
🇺🇸Wichita, Kansas, United States
Retina Associates, PA (site 295)
🇺🇸Shawnee Mission, Kansas, United States
Associated Retina Consultants (site 286)
🇺🇸Phoenix, Arizona, United States
Retinal Consultants of Arizona (site 209)
🇺🇸Phoenix, Arizona, United States
Midwest Eye Institute (site 253)
🇺🇸Indianapolis, Indiana, United States
Retinal Consultants of Nevada (site 273)
🇺🇸Las Vegas, Nevada, United States
Cincinnati Eye Institute (site 285)
🇺🇸Cincinnati, Ohio, United States
Houston Eye Associates (site 321)
🇺🇸Houston, Texas, 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
Eye Centre Pasqua Hospital (site 299)
🇨🇦Regina, Saskatchewan, Canada
Retina Centers PC (site 215)
🇺🇸Tucson, Arizona, United States
Magruder Eye Institute (site 264)
🇺🇸Orlando, Florida, United States
Southern Vitreoretinal Associates, PL (site 309)
🇺🇸Tallahassee, Florida, United States
Center for Retina and Macular Disease (site 293)
🇺🇸Winter Haven, Florida, United States
Vitreous-Retina-Macula Consultants of New York (site 239)
🇺🇸New York, New York, United States
Black Hills Regional Eye Institute (site 202)
🇺🇸Rapid City, South Dakota, United States
Ophthalmology Associates of PA (site 297)
🇺🇸Bala Cynwyd, Pennsylvania, United States
Retina Research Center (site 204)
🇺🇸Austin, Texas, United States
Ivey Eye Institute (site 314)
🇨🇦London, Ontario, Canada
Palmetto Retina Center (site 275)
🇺🇸West Columbia, South Carolina, United States
Eye Centers of Louisville (site 251)
🇺🇸Louisville, Kentucky, United States
Calgary Retina Consultants (site 318)
🇨🇦Calgary, Alberta, Canada
Eye Care Associates of East Texas (site 282)
🇺🇸Tyler, Texas, United States
Southeastern Retina Associates, PC (Site 250)
🇺🇸Knoxville, Tennessee, United States
Retina Associates of Cleveland (site 228)
🇺🇸Beachwood, Ohio, United States
University of Texas Medical Branch- Galveston (site 301
🇺🇸Galveston, Texas, United States
University of Virginia- Ophthalmology Dept. (site 254)
🇺🇸Charlottesville, Virginia, United States
Valley Retina Institue, PA (site 258)
🇺🇸McAllen, Texas, United States
Canadian Centre for Advanced Eye Therapeutics (site 291)
🇨🇦Mississauga, Ontario, Canada
University of South Florida Eye Institute (site 311)
🇺🇸Tampa, Florida, United States
Retina and Vitreous Center of Southern Oregon (site 271)
🇺🇸Ashland, Oregon, United States
Retina Associates of New Jersey (site 298)
🇺🇸Teaneck, New Jersey, United States