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

Sponsor

OPKO Health, Inc. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00557791

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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®.

Condition or Disease	Intervention/Treatment	Phase
Age Related Macular Degeneration	Drug: Bevasiranib Drug: ranibizumab	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2009

Anticipated Primary Completion Date :

Jul 1, 2011

Anticipated Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A Lucentis® (0.5 mg) every 4 weeks.	Drug: ranibizumab Lucentis® (0.5 mg) administered intravitreally every 4 weeks. Other Names: Lucentis®
Experimental: B 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
Experimental: C 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
Experimental: D 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

Outcome Measures

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). [60 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts 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.