We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00499590
First Posted: July 11, 2007
Last Update Posted: October 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
OPKO Health, Inc.
July 10, 2007
July 11, 2007
September 25, 2014
October 6, 2014
October 6, 2014
August 2007
March 2009   (Final data collection date for primary outcome measure)
Visual Acuity [ Time Frame: week 60 ]
avoidance of 3 or more lines of vision loss
Visual Acuity [ Time Frame: week 60 ]
Complete list of historical versions of study NCT00499590 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD
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).
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Macular Degeneration
  • Drug: bevasiranib
    Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks
  • Drug: ranibizumab
    Lucentis® (0.5 mg)administered intravitreally every 4 weeks.
    Other Name: Lucentis®
  • Active Comparator: A
    Lucentis® (0.5mg) every 4 weeks.
    Intervention: Drug: ranibizumab
  • 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.
    Intervention: Drug: bevasiranib
  • 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.
    Intervention: Drug: bevasiranib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
338
May 2009
March 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00499590
ACU301
Yes
Not Provided
Not Provided
OPKO Health, Inc.
OPKO Health, Inc.
Not Provided
Study Director: Denis O'Shaughnessy, Ph.D. Senior VP of Clincial Development
OPKO Health, Inc.
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP