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

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.
 
ClinicalTrials.gov Identifier: NCT00499590
Recruitment Status : Terminated
First Posted : July 11, 2007
Results First Posted : October 6, 2014
Last Update Posted : October 6, 2014
Sponsor:
Information provided by (Responsible Party):
OPKO Health, Inc.

Tracking Information
First Submitted Date  ICMJE July 10, 2007
First Posted Date  ICMJE July 11, 2007
Results First Submitted Date  ICMJE September 25, 2014
Results First Posted Date  ICMJE October 6, 2014
Last Update Posted Date October 6, 2014
Study Start Date  ICMJE August 2007
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2014)
Visual Acuity [ Time Frame: week 60 ]
avoidance of 3 or more lines of vision loss
Original Primary Outcome Measures  ICMJE
 (submitted: July 10, 2007)
Visual Acuity [ Time Frame: week 60 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2007)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD
Official Title  ICMJE 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).
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Macular Degeneration
Intervention  ICMJE
  • 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®
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 29, 2014)
338
Original Estimated Enrollment  ICMJE
 (submitted: July 10, 2007)
330
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00499590
Other Study ID Numbers  ICMJE ACU301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party OPKO Health, Inc.
Study Sponsor  ICMJE OPKO Health, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Denis O'Shaughnessy, Ph.D. Senior VP of Clincial Development
PRS Account OPKO Health, Inc.
Verification Date September 2014

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