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Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD (CARBON)
This study is not yet open for participant recruitment.
Verified by Opko Health, Inc., January 2009
Sponsored by: Opko Health, Inc.
Information provided by: Opko Health, Inc.
ClinicalTrials.gov Identifier: NCT00557791
  Purpose

The purpose of this study is to compare the safety and effectiveness of three doses of intravitreal bevasiranib sodium as maintenance therapy for Age-Related Macular Degeneration following initiation of anti-VEGF therapy with three doses of Lucentis®.


Condition Intervention Phase
Age Related Macular Degeneration
 Drug: Bevasiranib
Drug: ranibizumab
 Phase III

Genetics Home Reference related topics: X-linked juvenile retinoschisis
MedlinePlus related topics: Dietary Sodium Macular Degeneration
Drug Information available for: Ranibizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase 3, Randomized, Double-Masked, Parallel-Assignment and Dose-Finding Study of Intravitreal Bevasiranib Sodium, Administered Every 8 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).

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

Primary Outcome Measures:
  • Primary efficacy measure: The proportion of patients at week 60 in each group with a successful visual acuity outcome (as defined as avoidance of a 3, or more, line loss in vision). [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time from tx initiation to 1st use of rescue [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
  • Distribution of change in VA from baseline to 60 weeks [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients at week 60 with a 3, or more, line gain in vision [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 496
Study Start Date: November 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Active Comparator
Lucentis® (0.5 mg) every 4 weeks.
Drug: ranibizumab
Lucentis® (0.5 mg) administered intravitreally every 4 weeks.
B: Experimental
Bevasiranib (1.0 mg) 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
Three doses (1.0mg, 2.0mg, 2.5mg) of bevasiranib administered intravitreally every 8 weeks
C: Experimental
Bevasiranib (2.0 mg) 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
Three doses (1.0mg, 2.0mg, 2.5mg) of bevasiranib administered intravitreally every 8 weeks
D: Experimental
Bevasiranib (2.5 mg) 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
Three doses (1.0mg, 2.0mg, 2.5mg) of bevasiranib administered intravitreally every 8 weeks

  Eligibility

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

Inclusion Criteria:

  • Patients must be age 50 years or older
  • Patients must have predominantly classic, minimally classic or occult with no classic lesions secondary to Age Related Macular Degeneration.
  • The study eye must have ETDRS best corrected visual acuity of 69 to 24 letters (20/40 to 20/320 Snellen equivalent).
  • Patients must be willing and able to return for scheduled monthly follow-up visits for two-years.

Exclusion Criteria:

  • 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)
  • Any intraocular surgery of the study eye within 12 weeks of screening
  • Previous posterior vitrectomy of the study eye
  • 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: NCT00557791

Contacts
Contact: Clinical Team clinicaltrials@opko.com

Sponsors and Collaborators
Opko Health, Inc.
Investigators
Study Director: Naveed Shams, MD SVP at Opko Health
  More Information

Responsible Party: Opko Health ( Naveed Shams )
Study ID Numbers: ACU302
Study First Received: November 13, 2007
Last Updated: January 12, 2009
ClinicalTrials.gov Identifier: NCT00557791  
Health Authority: United States: Food and Drug Administration

Keywords provided by Opko Health, Inc.:
AMD
ARMD
Exudative Macular Degeneration
Bevasiranib
siRNA

Study placed in the following topic categories:
Signs and Symptoms
Eye Diseases
Retinal Degeneration
 Macular Degeneration
Retinal Diseases
Retinal degeneration

ClinicalTrials.gov processed this record on January 15, 2009



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