Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD
NCT ID: NCT00499590
Last Updated: 2014-10-06
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
338 participants
INTERVENTIONAL
2007-08-31
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
Lucentis® (0.5mg) every 4 weeks.
ranibizumab
Lucentis® (0.5 mg)administered intravitreally every 4 weeks.
B
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.
bevasiranib
Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks
C
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.
bevasiranib
Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks
Interventions
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bevasiranib
Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks
ranibizumab
Lucentis® (0.5 mg)administered intravitreally every 4 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
50 Years
ALL
No
Sponsors
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OPKO Health, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Denis O'Shaughnessy, Ph.D.
Role: STUDY_DIRECTOR
Senior VP of Clincial Development
Locations
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Retinal Consultants of Arizona (site 209)
Phoenix, Arizona, United States
Associated Retina Consultants (site 286)
Phoenix, Arizona, United States
Retina Centers PC (site 215)
Tucson, Arizona, United States
Eye Medical Center (site 287)
Fresno, California, United States
Northern California Retina Vitreous Associates (site 320)
Mountain View, California, United States
Retina Institute of California (site 207)
Pasadena, California, United States
Retina Consultants San Diego (site 232)
Poway, California, United States
Retinal Consultants Medical Group (site 289)
Sacramento, California, United States
Orange County Retina Medical Group (site 252)
Santa Ana, California, United States
Miramar Eye Specialists Medical Group (site 245)
Ventura, California, United States
The Eye Care Group, PC (site 315)
Waterbury, Connecticut, United States
Florida Eye Clinic (site 257)
Altamonte Springs, Florida, United States
Florida Eye Microsurgical Institute, Inc. (site 217)
Boynton Beach, Florida, 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
Magruder Eye Institute (site 264)
Orlando, Florida, United States
Southern Vitreoretinal Associates, PL (site 309)
Tallahassee, Florida, United States
University of South Florida Eye Institute (site 311)
Tampa, Florida, United States
Center for Retina and Macular Disease (site 293)
Winter Haven, Florida, United States
Southeast Retina Center (site 268)
Augusta, Georgia, United States
Midwest Eye Institute (site 253)
Indianapolis, Indiana, United States
Retina Associates, PA (site 295)
Shawnee Mission, Kansas, United States
Vitreo-Retinal Consultants & Surgeons, P.A. (site 274)
Wichita, Kansas, United States
Eye Centers of Louisville (site 251)
Louisville, Kentucky, United States
Retina Specialists (site 231)
Towson, Maryland, United States
Retina Associates St. Louis (site 300)
Florissant, Missouri, United States
Eye Foundation of Kansas City Truman Medical Center (site 272)
Kansas City, Missouri, United States
Retinal Consultants of Nevada (site 273)
Las Vegas, Nevada, 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-Vitreous Consultants (site 216)
Livingston, New Jersey, United States
Retina Associates of New Jersey (site 298)
Teaneck, New Jersey, United States
Capital Region Retina (site 316)
Albany, New York, 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
Carolina Eye Associates (site 308)
Southern Pines, North Carolina, United States
Retina Associates of Cleveland (site 228)
Beachwood, Ohio, United States
Cincinnati Eye Institute (site 285)
Cincinnati, Ohio, United States
Retina Associates of Cleveland, Inc. (site 219)
Lakewood, Ohio, United States
Retina-Vitreous Associates (site 266)
Toledo, Ohio, United States
Retina and Vitreous Center of Southern Oregon (site 271)
Ashland, Oregon, United States
Ophthalmology Associates of PA (site 297)
Bala-Cynwyd, Pennsylvania, United States
Palmetto Retina Center (site 275)
West Columbia, South Carolina, United States
Black Hills Regional Eye Institute (site 202)
Rapid City, South Dakota, United States
Southeastern Retina Associates, PC (Site 250)
Knoxville, Tennessee, United States
Retina Research Institute of Texas, L.L.C. (site 269)
Abilene, Texas, United States
Austin Retina Associates (site 304)
Austin, Texas, United States
Retina Research Center (site 204)
Austin, Texas, United States
University of Texas Medical Branch- Galveston (site 301
Galveston, Texas, United States
Houston Eye Associates (site 321)
Houston, Texas, United States
Valley Retina Institue, PA (site 258)
McAllen, Texas, United States
Eye Care Associates of East Texas (site 282)
Tyler, 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
University of Virginia- Ophthalmology Dept. (site 254)
Charlottesville, Virginia, United States
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
Sunnybrook Health Sciences Centre (site 305)
Toronto, Ontario, Canada
Eye Centre Pasqua Hospital (site 299)
Regina, Saskatchewan, Canada
Countries
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Other Identifiers
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ACU301
Identifier Type: -
Identifier Source: org_study_id
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