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

Study Overview
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Brief Summary
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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®.

Official Title
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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).

Conditions
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Age Related Macular Degeneration

Intervention / Treatment
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* Drug: Bevasiranib
* Drug: ranibizumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Lucentis® (0.5 mg) every 4 weeks. | Drug: ranibizumab<br>* Lucentis® (0.5 mg) administered intravitreally every 4 weeks.<br>* Other names: Lucentis®;|
| Experimental: B<br>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<br>* Three doses (1.0mg, 2.0mg, 2.5mg) of bevasiranib administered intravitreally every 8 weeks<br>|
| Experimental: C<br>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<br>* Three doses (1.0mg, 2.0mg, 2.5mg) of bevasiranib administered intravitreally every 8 weeks<br>|
| Experimental: D<br>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<br>* Three doses (1.0mg, 2.0mg, 2.5mg) of bevasiranib administered intravitreally every 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMD, ARMD, Exudative Macular Degeneration, Bevasiranib, siRNA