Efficacy of Ozurdex® in the Treatment of Diabetic Macular Edema (DME)

Study Overview
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Brief Summary
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This study will evaluate the efficacy of Ozurdex® as prescribed in clinical practice in France for the treatment of Diabetic Macular Edema (DME).

Official Title
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Efficacy of Ozurdex® in the Treatment of Diabetic Macular Edema (DME)

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: -Patient with Diabetic Macular Edema (DME) treated with Ozurdex® in clinical practice. Exclusion Criteria: -Patient not residing in metropolitan France.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OZURDEX®<br>Patients prescribed dexamethasone intravitreal implant (OZURDEX®) in clinical practice for the treatment of Diabetic Macular Edema. | Drug: dexamethasone intravitreal implant<br>* Dexamethasone intravitreal implant (OZURDEX®) as prescribed in clinical practice.<br>* Other names: OZURDEX®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Gain in Best Corrected Visual Acuity (BCVA) compared to Baseline Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale |  | Baseline to Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Achieve Maximum Gain in BCVA |  | 24 Months | 
| Change from Baseline in BCVA |  | Baseline, Week 6, Months 6, 12, 18 and 24 | 
| Percentage of Participants with a Gain (Improvement) in BCVA of at Least 10 Letters from Baseline |  | Baseline, Week 6, Month 6, 12, 18 and 24 | 
| Percentage of Participants with a Gain (Improvement) in BCVA of at Least 15 Letters from Baseline |  | Baseline, Week 6, Month 6, 12, 18 and 24 | 
| Change from Baseline in Retinal Thickness |  | Baseline, Month 24 | 
| Percentage of Participants with a 20% Reduction in Retinal Thickness compared to Baseline |  | Baseline, Month 24 | 
| Percentage of Participants with Disappearance of DME defined by Disappearance of Cyst or Obtaining a Normal Retinal Thickness |  | Month 24 | 
| Percentage of Participants Categorized by Demographic Characteristics Treated or Not Treated with Ozurdex® |  | Day 1 | 
| Percentage of Physicians Categorized by Age, Sex, Type of Practice, Number of Yearly Injections |  | Day 1 | 
| Percentage of Participants Categorized by Characteristics of Disease (DME or Diabetes) |  | Day 1 | 
| Percentage of Participants Categorized by Treatment Methods at Inclusion (Therapeutic Decision for inclusion or Reason for Non-Treatment) |  | Day 1 | 
| Percentage of Participants Categorized by Conditions when Placed on Treatment (Patient Characteristics, Glycosylated Hemoglobin (HbA1c) Level Control, Blood Pressure Control, Prior Treatments, Prior Treatment Failure) |  | Day 1 | 
| Percentage of Participants Categorized by Conditions when Use of Ozurdex® (Number of Injections, Number of Follow-up Visits, Criteria for Retreatment and Discontinuation of Treatment) |  | 24 Months | 
| Percentage of Participants with at Least 1 Adverse Event (AE) based on intensity, relationship with the treatment and severity |  | 24 Months | 
| Percentage of Participants by Intra-ocular Pressure (IOP) Categories (≥25 and ≥35 mmHg) |  | 24 Months | 
| Number of Participants with Intra-ocular Pressure (IOP) Changes >10 mmHg from Baseline |  | 24 Months | 
| Percentage of Participants Treated with a Hypotonic Agent, Laser, Filtration Surgery |  | 24 Months | 
| Number of Participants with Incident Cataracts |  | 24 Months | 
| Number of Participants with Cataract Surgeries Related to Treatment or Injection |  | 24 Months | 
| Percentage of Participants with Serious Adverse Events |  | 24 Months | 
| Percentage of Participants with Death |  | 24 Months |