A Study to Evaluate the Effectiveness and Safety of OZURDEX® in Patients With Diabetic Macular Edema But Never Treated

Study Overview
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Brief Summary
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This study will evaluate the efficacy and safety of OZURDEX in patients with Diabetic Macular Edema when used in a real world setting in Spain and Portugal.

Official Title
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A 12-month, Prospective, Open-label, Phase 4 Study to Evaluate the Efficacy and Safety of OZURDEX® (Dexamethasone Intravitreal Implant) in Treatment Naïve Patients (According to Standard Clinical Practice) With Diabetic Macular Edema

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: Dexamethasone Intravitreal Implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prior diagnosis of diabetes mellitus (type 1 or type 2) Media clarity, pupillary dilation, and patient cooperation sufficient for all study procedures Written informed consent obtained in accordance with all local privacy requirements Exclusion Criteria: Uncontrolled systemic disease History of disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease condition that contraindicates the use of the investigational drug, might affect the interpretation of study results, or render the patient at high risk from treatment complications Patients who have been previously treated for DME (two focal laser allowed) Untreated diabetes or anticipated change (increase) of antidiabetic medications during the study Elevated IOP or glaucoma diagnosis Any active ocular infection or inflammation Aphakia A substantial cataract is present that is likely to be decreasing visual acuity by three lines or more (i.e., cataract would be reducing visual acuity to 20/40 or worse if the eye was otherwise normal) Anticipated need for ocular surgery during the study History of vitrectomy or incisional glaucoma surgery - Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception Known allergy, hypersensitivity or contraindication to the study medication, its components, or povidone iodine

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: Ozurdex<br>OZURDEX implant 700 μg | Drug: Dexamethasone Intravitreal Implant<br>* Implant 700 μg<br>|

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 (BCVA) 2 months (± 2 weeks) after the last injection |  | Baseline, at Month 10 through 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in Central Retinal Thickness (CRT) 2 months (± 2 weeks) after the last injection received |  | Baseline, at Month 10 through 12 | 
| Mean retreatment interval in months |  | During the 12 to 14-month study | 
| Area under the curve (AUC) for CRT |  | Baseline, During the 12 to 14-month study | 
| AUC for BCVA |  | Baseline, During the 12 to 14-month study | 
| Mean change in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) | 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better functioning. Original numeric values from the survey will be recoded with the worst and best possible scores set at 0 and 100 points, respectively. In this format, scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score. | Baseline, at Month 14 | 
| Proportion of patients with 2nd injection |  | During the 12 to 14-month study | 
| Proportion of patients with 3rd injection |  | During the 12 to 14-month study | 
| Mean number of injections administered |  | During the 12- to 14-month study | 
| Time to 3rd injection |  | During the 12 to 14-month study | 
| Time to 2nd injection |  | During the 12 to 14-month study |