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

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 bevasiranib given either every 8 weeks or every 12 weeks after an initial pre-treatment with 3 injections of Lucentis® (ranibizumab injection) compared to Lucentis® given every 4 weeks to people with wet AMD. Patients will be assigned at random (like tossing a coin) to receive one of three treatments options for 104 weeks.

Official Title
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A Phase 3, Randomized, Double-masked, Parallel-assignment Study of Intravitreal Bevasiranib Sodium, Administered Every 8 or 12 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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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® (0.5mg) every 4 weeks. | Drug: ranibizumab<br>* Lucentis® (0.5 mg)administered intravitreally every 4 weeks.<br>* Other names: Lucentis®;|
| Experimental: B<br>Bevasiranib (2.5mg) 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>* Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks<br>|
| Experimental: C<br>Bevasiranib (2.5mg) every 12 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>* Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | avoidance of 3 or more lines of vision loss | week 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for Rescue Therapy, Time to Rescue Therapy, and Number of Patients With a 3 or More Line Gain in Vision |  | Week 60 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMD, Macular Degeneration, bevasiranib, COBALT study, age related macular degeneration, wet AMD, wet age related macular degeneration