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

July 10, 2007
November 5, 2013
August 2007
March 2009   (final data collection date for primary outcome measure)
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.
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 ] [ 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.
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 ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
336
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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00499590
ACU301
Yes
Opko Health, Inc.
Opko Health, Inc.
Not Provided
Study Director: Denis O'Shaughnessy, Ph.D. Senior VP of Clincial Development
Opko Health, Inc.
November 2013

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