Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema

Study Overview
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Brief Summary
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The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be followed for 26 weeks.

Conditions
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Vitrectomy, Diabetic Macular Edema

Intervention / Treatment
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* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older with diabetic macular edema History of vitrectomy Central retinal thickness ≥ 275 µm Visual acuity between 20/320 and 20/40 in the study eye and no worse than 20/200 in the other eye Exclusion Criteria: Known anticipated need for ocular surgery during the study period History of glaucoma or current high eye pressure requiring more than 1 medication Uncontrolled systemic disease Known allergy to the study medication Known steroid-responder Use of systemic steroids Female subjects that are pregnant, nursing or planning a pregnancy

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 700 µg Dexamethasone Implant<br>700 µg dexamethasone implant in the study eye at Day 1 | Drug: Dexamethasone<br>* 700 µg Dexamethasone Posterior Segment Drug Delivery System Applicator System at Day 1 in the study eye.<br>* Other names: OZURDEX®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Central Retinal Thickness in the Study Eye | Central retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative change from baseline in retinal thickness indicates an improvement and a positive change from baseline indicates a worsening. | Baseline, Week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | BCVA is measured in the study eye 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 from baseline in the number of letters read correctly indicates improvement and a decrease from baseline in the number of letters read correctly indicates a worsening. | Baseline, Week 26 | 
| Percentage of Patients With at Least 10 Letters of Improvement in BCVA From Baseline in the Study Eye | BCVA is measured in the study eye 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 indicates improvement and a decrease in the number of letters read correctly indicates a worsening. | Baseline, Week 26 | 
| Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye | Fluorescein leakage is measured in the study eye by FA. FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. The assessment of fluorescein leakage compared to baseline is categorized as Improved (leakage area decreased ≥ 10%), Unchanged (leakage area changed < 10%), and Worsened (leakage area increased ≥ 10%). | Baseline, Week 26 |