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
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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
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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.
not applicable

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  
Number of Participants  
[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
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1.  Primary:   Visual Acuity   [ Time Frame: week 60 ]

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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


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
Results First Received: September 25, 2014
Last Updated: September 29, 2014
Health Authority: United States: Food and Drug Administration