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

Phase 3

Withdrawn

• Conditions: Age Related Macular Degeneration
• Interventions: Drug: Bevasiranib; Drug: ranibizumab

• Registration Number: NCT00557791
• Lead Sponsor: OPKO Health, Inc.

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®.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-13
• Study First Submitted QC: 2007-11-13
• Study First Posted: 2007-11-14
• Study Start: 2009-11
• Status Verified: 2011-02
• Primary Completion: 2011-07
• Study Completion: 2012-07
• Last Update Submitted: 2015-03-05
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Bevasiranib	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.
C	Bevasiranib	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.
D	Bevasiranib	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.
A	ranibizumab	Lucentis® (0.5 mg) every 4 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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