Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
OPKO Health, Inc.
ClinicalTrials.gov Identifier:
NCT00499590
First received: July 10, 2007
Last updated: September 29, 2014
Last verified: September 2014
Results First Received: September 25, 2014  
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
Condition: Macular Degeneration
Interventions: Drug: bevasiranib
Drug: ranibizumab

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lucentis®

Lucentis® (0.5mg) every 4 weeks.

ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks.

Bevasiranib 8 Weeks

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

Bevasiranib 12 Weeks

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


Participant Flow:   Overall Study
    Lucentis®   Bevasiranib 8 Weeks   Bevasiranib 12 Weeks
STARTED   113   112   113 
COMPLETED   0   0   0 
NOT COMPLETED   113   112   113 
Study Terminated                112                112                112 
Not treated                1                0                1 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Lucentis

Lucentis® (0.5mg) every 4 weeks.

ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks.

Bevasiranib 8 Weeks

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

Bevasiranib 12 Weeks

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

Total Total of all reporting groups

Baseline Measures
   Lucentis   Bevasiranib 8 Weeks   Bevasiranib 12 Weeks   Total 
Overall Participants Analyzed 
[Units: Participants]
 113   112   113   338 
Age 
[Units: Years]
Mean (Full Range)
 77.6 
 (56 to 90) 
 77.2 
 (52 to 95) 
 78.3 
 (57 to 94) 
 77.7 
 (52 to 95) 
Gender 
[Units: Participants]
       
Female   80   72   59   211 
Male   33   40   54   127 
Region of Enrollment 
[Units: Participants]
       
United States   61   59   64   184 
Austria   4   5   4   13 
Canada   8   10   5   23 
France   22   24   20   66 
Israel   9   7   6   22 
Italy   5   2   2   9 
Portugal   3   3   5   11 
Spain   1   2   7   10 


  Outcome Measures

1.  Primary:   Visual Acuity   [ Time Frame: week 60 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

2.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study was terminated early.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jane Hsiao, PhD, MBA
Organization: OPKO Health, Inc.
phone: 305-575-6004
e-mail: jhsiao@opko.com



Responsible Party: OPKO Health, Inc.
ClinicalTrials.gov Identifier: NCT00499590     History of Changes
Other Study ID Numbers: ACU301
Study First Received: July 10, 2007
Results First Received: September 25, 2014
Last Updated: September 29, 2014
Health Authority: United States: Food and Drug Administration