A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus

Study Overview
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Brief Summary
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There is a need to find an effective therapy for diabetic patients who develop macular edema after cataract surgery.

Detailed Description
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The objective of this study is to assess the safety and efficacy of the OZURDEX® intraocular implant in patients with diabetes mellitus, who develop macular edema after cataract surgery

Official Title
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A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus

Conditions
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Macular Edema, Diabetes Mellitus

Intervention / Treatment
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* Drug: Dexamethasone intravitreal implant
* Drug: Steroid plus NSAID eye drop combination therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has diagnosis of Diabetes Mellitus, Type I or II. Patient has experienced the development of macular edema following cataract surgery in at least one eye. Patient has had cataract surgery within 90 days prior to the screening visit. Exclusion Criteria: Patient has other significant ocular disease in study eye, including glaucoma. Patient has any active infection in the study eye. Patient has uncontrolled systemic illness (i.e., uncontrolled blood pressure, uncontrolled diabetes mellitus). Patient has experienced a significant increase in intraocular pressure following a prior treatment with topical or intravitreal steroidal medication. Patient has received the OZURDEX® implant before in the study eye.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OZURDEX intraocular implant<br>OZURDEX (dexamethasone posterior segment drug delivery system (DEX PS DDS), 0.7 mg | Drug: Dexamethasone intravitreal implant<br> <br> * Other names: OZURDEX;|
| Active Comparator: Steroid plus NSAID eye drop combination therapy<br>NSAID eye drop: Acular LS Steriod eye drop: Pred Forte | Drug: Steroid plus NSAID eye drop combination therapy<br> <br> * Other names: Acular LS and Pred Forte;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Best Corrected Visual Acuity |  | 1 months | 
| Mean Change in Best Corrected Visual Acuity |  | 2 months | 
| Mean Change in Best Corrected Visual Acuity |  | 3 months | 
| Mean Change in Central Retinal Thickness |  | 1 month | 
| Mean Change in Central Retinal Thickness |  | 2 months | 
| Mean Change in Central Retinal Thickness |  | 3 months | 
| Mean Change in Intraocular Pressure |  | 3 months |