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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:
Opko Health, Inc.
ClinicalTrials.gov Identifier:
NCT00499590
First received: July 10, 2007
Last updated: June 20, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Macular Degeneration
 Drug: bevasiranib
Drug: ranibizumab
 Phase 3

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
Official Title: 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).

Resource links provided by NLM:

Drug Information available for: Ranibizumab
U.S. FDA Resources

Further study details as provided by Opko Health, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 336
Study Start Date: August 2007
Study Completion Date: May 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Lucentis® (0.5mg) every 4 weeks.
 Drug: ranibizumab
Lucentis® (0.5 mg)administered intravitreally every 4 weeks.
Other Name: Lucentis®
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.
 Drug: bevasiranib
Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks
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.
 Drug: bevasiranib
Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00499590

  Show 60 Study Locations
Sponsors and Collaborators
Opko Health, Inc.
Investigators
Study Director: Denis O'Shaughnessy, Ph.D. Senior VP of Clincial Development
  More Information

No publications provided

Responsible Party: Denis O'Shaughnessy, PhD Senior VP Clinical Development, Opko Health
ClinicalTrials.gov Identifier: NCT00499590     History of Changes
Other Study ID Numbers: ACU301
Study First Received: July 10, 2007
Last Updated: June 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Opko Health, Inc.:
AMD
Macular Degeneration
bevasiranib
COBALT study
 age related macular degeneration
wet AMD
wet age related macular degeneration

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on June 17, 2013