Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD (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).

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00557791

Acronym

CARBON

Enrollment

Registered

2007-11-14

Start date

2009-11-30

Completion date

2012-07-31

Last updated

2015-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age Related Macular Degeneration

Keywords

AMD, ARMD, Exudative Macular Degeneration, Bevasiranib, siRNA

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®.

Interventions

DRUGBevasiranib

Three doses (1.0mg, 2.0mg, 2.5mg) of bevasiranib administered intravitreally every 8 weeks

DRUGranibizumab

Lucentis® (0.5 mg) administered intravitreally every 4 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026