Safety and Efficacy of Dexamethasone as Adjunctive Therapy to Ranibizumab in Subjects With Choroidal Neovascularization and Age-Related Macular Degeneration

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of dexamethasone (OZURDEX®) as adjunctive therapy to ranibizumab (LUCENTIS®) compared with ranibizumab alone in the treatment of patients with choroidal neovascularization secondary to age-related macular degeneration

Conditions
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Subfoveal Choroidal Neovascularization, Age-Related Maculopathy

Intervention / Treatment
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* Drug: 700 ug dexamethasone
* Biological: ranibizumab
* Other: sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Received at least 2 and no more than 3 monthly Lucentis or Avastin injections Last Lucentis or Avastin was injected approximately 4 weeks prior to screening Visual acuity between 20/320 and 20/40 Exclusion Criteria: Active ocular infection Contraindication to pupil dilation in either eye Eye surgery including cataract surgery and/or laser of any type within 3 months

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 700 ug dexamethasone and ranibizumab<br>Intravitreal injection of 700 ug dexamethasone and ranibizumab into study eye | Drug: 700 ug dexamethasone<br>* Intravitreal injection of 700 ug dexamethasone into study eye<br>* Other names: OZURDEX®;Biological: ranibizumab<br>* Intravitreal injection of ranibizumab into study eye<br>* Other names: Lucentis®;|
| Active Comparator: ranibizumab and sham<br>Intravitreal injection of ranibizumab and Sham into study eye | Biological: ranibizumab<br>* Intravitreal injection of ranibizumab into study eye<br>* Other names: Lucentis®;Other: sham<br>* Sham needle-less injection administered in the study eye<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. | Baseline, Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Patients Having 15 or More Letter Improvement From Baseline in Best Corrected Visual Acuity at Month 12 | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. | Baseline, Month 12 | 
| Change From Baseline in Central Retinal Thickness at Month 12 as Measured by Optical Coherence Tomography | Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed on the study eye after pupil dilation at baseline and Month 12. | Baseline, Month 12 | 
| Change From Baseline in Area Leakage of Choroidal Neovascularization at Month 12 as Measured by Fluorescein Angiography | Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA was performed on the study eye after dilation at baseline and Week 12. | Baseline, Month 12 |