Back to resultsSafety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD (CARBON) (CARBON)
Primary Purpose
Age Related Macular Degeneration
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Bevasiranib
ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring AMD, ARMD, Exudative Macular Degeneration, Bevasiranib, siRNA
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
A
B
C
D
Arm Description
Lucentis® (0.5 mg) every 4 weeks.
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.
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.
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.
Outcomes
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).
Secondary Outcome Measures
Time from tx initiation to 1st use of rescue
Distribution of change in VA from baseline to 60 weeks
Proportion of patients at week 60 with a 3, or more, line gain in vision
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00557791
Brief Title
Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD (CARBON)
Acronym
CARBON
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).
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Study never initiated
Study Start Date
November 2009 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
July 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
OPKO Health, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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®.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
Keywords
AMD, ARMD, Exudative Macular Degeneration, Bevasiranib, siRNA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Lucentis® (0.5 mg) every 4 weeks.
Arm Title
B
Arm Type
Experimental
Arm Description
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.
Arm Title
C
Arm Type
Experimental
Arm Description
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.
Arm Title
D
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bevasiranib
Intervention Description
Three doses (1.0mg, 2.0mg, 2.5mg) of bevasiranib administered intravitreally every 8 weeks
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis®
Intervention Description
Lucentis® (0.5 mg) administered intravitreally every 4 weeks.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Time from tx initiation to 1st use of rescue
Time Frame
60 weeks
Title
Distribution of change in VA from baseline to 60 weeks
Time Frame
60 weeks
Title
Proportion of patients at week 60 with a 3, or more, line gain in vision
Time Frame
60 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naveed Shams, MD
Organizational Affiliation
SVP at Opko Health
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD (CARBON)
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