Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With Diabetic Macular Edema

Study Overview
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Brief Summary
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This study will compare the safety and efficacy of the 700 ug dexamethasone intravitreal implant with ranibizumab 0.5 mg intravitreal injections in patients with diabetic macular edema (DME).

Conditions
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Macular Edema

Intervention / Treatment
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* Drug: dexamethasone Intravitreal Implant
* Drug: ranibizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of type 1 or 2 diabetes mellitus Diagnosis of macular edema Visual acuity between 20/200 to 20/40 Exclusion Criteria: Eye surgery to the study eye within 3 months Use of Ozurdex® within 9 months Any active ocular inflammation and infection Diagnosis of glaucoma Use of anti-VEGF treatment (e.g., Lucentis®) within 3 months in the eye or systemic use (e.g., Avastin®) within 6 months

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexamethasone Intravitreal Implant<br>Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10. | Drug: dexamethasone Intravitreal Implant<br>* Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.<br>* Other names: Ozurdex®;|
| Active Comparator: ranibizumab<br>Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression. | Drug: ranibizumab<br>* Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.<br>* Other names: Lucentis®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening. | Baseline, 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Foveal Thickness Measured by Optical Coherence Tomography (OCT) in the Study Eye | OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the fovea (part of the retina) in the study eye after pupil dilation. A negative change from baseline indicates an improvement (less foveal thickness) and a positive change from baseline indicates a worsening (more foveal thickness). | Baseline, Month 12 | 
| Change From Baseline in Total Area of Macular Leakage in the Study Eye Measured on Fluorescein Angiography (FA) | 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. A negative change from baseline indicates a decrease in leakage (improvement) and a positive change from baseline indicates an increase in leakage (worsening). | Baseline, Month 12 |