Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD (COBALT)

This study has been terminated.
(recommendation from the IDMC (Independent Data Monitoring Committee))
Sponsor:
Information provided by (Responsible Party):
Opko Health, Inc.
ClinicalTrials.gov Identifier:
NCT00499590
First received: July 10, 2007
Last updated: November 5, 2013
Last verified: November 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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).

Resource links provided by NLM:


Further study details as provided by Opko Health, Inc.:

Primary Outcome Measures:
  • Visual Acuity [ Time Frame: week 60 ] [ Designated as safety issue: No ]
    There was some suggestion that bevasiranib is efficacious even though it was slightly inferior to Lucentis® in the current trial. The evidence for efficacy is that average visual acuity remained positive through week 60 without rescue therapy; a lower proportion of patients avoided visual loss on the more frequent bevasiranib dosing arm; and there was a trend toward increased visual gain over Lucentis® at 12 weeks and earlier when bevasiranib and Lucentis® were staggered.


Secondary Outcome Measures:
  • Need for Rescue Therapy, Time to Rescue Therapy, and Number of patients with a 3 or more line gain in vision [ Time Frame: Week 60 ] [ Designated as safety issue: No ]
    Bevasiranib was generally well-tolerated. There was a trend toward more vision loss, retinal hemorrhage, and ocular inflammation/infection in the bevasiranib treatment groups compared to the Lucentis® group, but the number of patients affected was small. Vision loss could be recovered by rescue therapy in some cases but not in others.


Enrollment: 336
Study Start Date: August 2007
Study Completion Date: May 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Lucentis® (0.5mg) every 4 weeks.
Drug: ranibizumab
Lucentis® (0.5 mg)administered intravitreally every 4 weeks.
Other Name: Lucentis®
Experimental: 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.
Drug: bevasiranib
Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks
Experimental: 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.
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
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00499590

  Hide Study Locations
Locations
United States, Arizona
Associated Retina Consultants (site 286)
Phoenix, Arizona, United States, 85020
Retinal Consultants of Arizona (site 209)
Phoenix, Arizona, United States, 85014
Retina Centers PC (site 215)
Tucson, Arizona, United States, 85704
United States, California
Eye Medical Center (site 287)
Fresno, California, United States, 93720
Northern California Retina Vitreous Associates (site 320)
Mountain View, California, United States, 94040
Retina Institute of California (site 207)
Pasadena, California, United States, 91105
Retina Consultants San Diego (site 232)
Poway, California, United States, 93064
Retinal Consultants Medical Group (site 289)
Sacramento, California, United States, 95819
Orange County Retina Medical Group (site 252)
Santa Ana, California, United States, 92705
Miramar Eye Specialists Medical Group (site 245)
Ventura, California, United States, 93003
United States, Connecticut
The Eye Care Group, PC (site 315)
Waterbury, Connecticut, United States, 06708
United States, Florida
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
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
Southern Vitreoretinal Associates, PL (site 309)
Tallahassee, Florida, United States, 32308
University of South Florida Eye Institute (site 311)
Tampa, Florida, United States, 33612
Center for Retina and Macular Disease (site 293)
Winter Haven, Florida, United States, 33880
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
Retina Associates, PA (site 295)
Shawnee Mission, Kansas, United States, 66204
Vitreo-Retinal Consultants & Surgeons, P.A. (site 274)
Wichita, Kansas, United States, 67214
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
Retina Associates St. Louis (site 300)
Florissant, Missouri, United States, 63031
Eye Foundation of Kansas City Truman Medical Center (site 272)
Kansas City, Missouri, United States, 64108
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
Capital Region Retina (site 316)
Albany, New York, United States, 12206
Vitreous-Retina-Macula Consultants of New York (site 239)
New York, New York, United States, 10022
New York Eye & Ear Infirmary (site 272)
New York, New York, United States, 10003
United States, North Carolina
Carolina Eye Associates (site 308)
Southern Pines, North Carolina, United States, 28387
United States, Ohio
Retina Associates of Cleveland (site 228)
Beachwood, Ohio, United States, 44122
Cincinnati Eye Institute (site 285)
Cincinnati, Ohio, United States, 45242
Retina Associates of Cleveland, Inc. (site 219)
Lakewood, Ohio, United States, 44107
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 Institute of Texas, L.L.C. (site 269)
Abilene, Texas, United States, 79606
Retina Research Center (site 204)
Austin, Texas, United States, 78705
Austin Retina Associates (site 304)
Austin, Texas, United States, 78705
University of Texas Medical Branch- Galveston (site 301
Galveston, Texas, United States, 77555
Houston Eye Associates (site 321)
Houston, Texas, United States, 77025
Valley Retina Institue, PA (site 258)
McAllen, Texas, United States, 78503
Eye Care Associates of East Texas (site 282)
Tyler, Texas, United States, 75701
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
Ivey Eye Institute (site 314)
London, Ontario, Canada, N6A 4G5
Canadian Centre for Advanced Eye Therapeutics (site 291)
Mississauga, Ontario, Canada, L4W 1W9
Sunnybrook Health Sciences Centre (site 305)
Toronto, Ontario, Canada, M4N 3M5
Canada, Saskatchewan
Eye Centre Pasqua Hospital (site 299)
Regina, Saskatchewan, Canada, S4T 1A5
Sponsors and Collaborators
Opko Health, Inc.
Investigators
Study Director: Denis O'Shaughnessy, Ph.D. Senior VP of Clincial Development
  More Information

No publications provided

Responsible Party: Opko Health, Inc.
ClinicalTrials.gov Identifier: NCT00499590     History of Changes
Other Study ID Numbers: ACU301
Study First Received: July 10, 2007
Last Updated: November 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Opko Health, Inc.:
AMD
Macular Degeneration
bevasiranib
COBALT study
age related macular degeneration
wet AMD
wet age related macular degeneration

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 21, 2014