Study Stopped
Study never initiated
Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD (CARBON)
CARBON
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).
1 other identifier
interventional
N/A
0 countries
N/A
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®.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2009
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2007
CompletedFirst Posted
Study publicly available on registry
November 14, 2007
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedMarch 6, 2015
February 1, 2011
1.7 years
November 13, 2007
March 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
60 weeks
Secondary Outcomes (3)
Time from tx initiation to 1st use of rescue
60 weeks
Distribution of change in VA from baseline to 60 weeks
60 weeks
Proportion of patients at week 60 with a 3, or more, line gain in vision
60 weeks
Study Arms (4)
A
ACTIVE COMPARATORLucentis® (0.5 mg) every 4 weeks.
B
EXPERIMENTALBevasiranib (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.
C
EXPERIMENTALBevasiranib (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.
D
EXPERIMENTALBevasiranib (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.
Interventions
Three doses (1.0mg, 2.0mg, 2.5mg) of bevasiranib administered intravitreally every 8 weeks
Lucentis® (0.5 mg) administered intravitreally every 4 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Naveed Shams, MD
SVP at Opko Health
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 13, 2007
First Posted
November 14, 2007
Study Start
November 1, 2009
Primary Completion
July 1, 2011
Study Completion
July 1, 2012
Last Updated
March 6, 2015
Record last verified: 2011-02