Clinical trial NCT00499590: Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD
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).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Macular Degeneration
Keywords: AMD
Macular Degeneration
bevasiranib
COBALT study
age related macular degeneration
wet AMD
wet age related macular degeneration
Lead sponsor: OPKO Health, Inc.
Sponsor class: INDUSTRY
First posted: 2007-07-11
Enrollment: 338
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Visual Acuity
timeFrame: week 60
Secondary outcomes:
measure: Need for Rescue Therapy, Time to Rescue Therapy, and Number of Patients With a 3 or More Line Gain in Vision
timeFrame: Week 60
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Consultants of Arizona (site 209)
state: Arizona
city: Phoenix
country: United States
facility: Associated Retina Consultants (site 286)
state: Arizona
city: Tucson
country: United States
facility: Retina Centers PC (site 215)
state: Arizona
city: Fresno
country: United States
facility: Eye Medical Center (site 287)
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates (site 320)
state: California
city: Pasadena
country: United States
facility: Retina Institute of California (site 207)
state: California
city: Poway
country: United States
facility: Retina Consultants San Diego (site 232)
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group (site 289)
state: California
city: Santa Ana
country: United States
facility: Orange County Retina Medical Group (site 252)
state: California
city: Ventura
country: United States
facility: Miramar Eye Specialists Medical Group (site 245)
state: California
city: Waterbury
country: United States
facility: The Eye Care Group, PC (site 315)
state: Connecticut
city: Altamonte Springs
country: United States
facility: Florida Eye Clinic (site 257)
state: Florida
city: Boynton Beach
country: United States
facility: Florida Eye Microsurgical Institute, Inc. (site 217)
state: Florida
city: Fort Myers
country: United States
facility: Retina Health Center (site 247)
state: Florida
city: Fort Myers
country: United States
facility: National Ophthalmic Research Institute at Retina Consultants of SW Florida (site 270)
state: Florida
city: Orlando
country: United States
facility: Magruder Eye Institute (site 264)
state: Florida
city: Tallahassee
country: United States
facility: Southern Vitreoretinal Associates, PL (site 309)
state: Florida
city: Tampa
country: United States
facility: University of South Florida Eye Institute (site 311)
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina and Macular Disease (site 293)
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center (site 268)
state: Georgia
city: Indianapolis
country: United States
facility: Midwest Eye Institute (site 253)
state: Indiana
city: Shawnee Mission
country: United States
facility: Retina Associates, PA (site 295)
state: Kansas
city: Wichita
country: United States
facility: Vitreo-Retinal Consultants & Surgeons, P.A. (site 274)
state: Kansas
city: Louisville
country: United States
facility: Eye Centers of Louisville (site 251)
state: Kentucky
city: Towson
country: United States
facility: Retina Specialists (site 231)
state: Maryland
city: Florissant
country: United States
facility: Retina Associates St. Louis (site 300)
state: Missouri
city: Kansas City
country: United States
facility: Eye Foundation of Kansas City Truman Medical Center (site 272)
state: Missouri
city: Las Vegas
country: United States
facility: Retinal Consultants of Nevada (site 273)
state: Nevada
city: Portsmouth
country: United States
facility: Eyesight Ophthalmic Services, PA (site 290)
state: New Hampshire
city: Lawrenceville
country: United States
facility: Delaware Valley Retina Associates (site 261)
state: New Jersey
city: Livingston
country: United States
facility: Retina-Vitreous Consultants (site 216)
state: New Jersey
city: Teaneck
country: United States
facility: Retina Associates of New Jersey (site 298)
state: New Jersey
city: Albany
country: United States
facility: Capital Region Retina (site 316)
state: New York
city: New York
country: United States
facility: New York Eye & Ear Infirmary (site 272)
state: New York
city: New York
country: United States
facility: Vitreous-Retina-Macula Consultants of New York (site 239)
state: New York
city: Southern Pines
country: United States
facility: Carolina Eye Associates (site 308)
state: North Carolina
city: Beachwood
country: United States
facility: Retina Associates of Cleveland (site 228)
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute (site 285)
state: Ohio
city: Lakewood
country: United States
facility: Retina Associates of Cleveland, Inc. (site 219)
state: Ohio
city: Toledo
country: United States
facility: Retina-Vitreous Associates (site 266)
state: Ohio
city: Ashland
country: United States
facility: Retina and Vitreous Center of Southern Oregon (site 271)
state: Oregon
city: Bala Cynwyd
country: United States
facility: Ophthalmology Associates of PA (site 297)
state: Pennsylvania
city: West Columbia
country: United States
facility: Palmetto Retina Center (site 275)
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute (site 202)
state: South Dakota
city: Knoxville
country: United States
facility: Southeastern Retina Associates, PC (Site 250)
state: Tennessee
city: Abilene
country: United States
facility: Retina Research Institute of Texas, L.L.C. (site 269)
state: Texas
city: Austin
country: United States
facility: Austin Retina Associates (site 304)
state: Texas
city: Austin
country: United States
facility: Retina Research Center (site 204)
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch- Galveston (site 301
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates (site 321)
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institue, PA (site 258)
state: Texas
city: Tyler
country: United States
facility: Eye Care Associates of East Texas (site 282)
state: Texas
city: Salt Lake City
country: United States
facility: Rocky Mountain Retina Consultants (site 256)
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah, John A. Moran Eye Center (site 205)
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia- Ophthalmology Dept. (site 254)
state: Virginia
city: Calgary
country: Canada
facility: Calgary Retina Consultants (site 318)
state: Alberta
city: London
country: Canada
facility: Ivey Eye Institute (site 314)
state: Ontario
city: Mississauga
country: Canada
facility: Canadian Centre for Advanced Eye Therapeutics (site 291)
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre (site 305)
state: Ontario
city: Regina
country: Canada
facility: Eye Centre Pasqua Hospital (site 299)
state: Saskatchewan
Study officials:
affiliation: Senior VP of Clincial Development
name: Denis O'Shaughnessy, Ph.D.
role: STUDY_DIRECTOR
References: