Diabetic Macular Edema
Conditions
Brief summary
This study will evaluate the efficacy of Ozurdex® as prescribed in clinical practice in France for the treatment of Diabetic Macular Edema (DME).
Interventions
DRUGdexamethasone intravitreal implant
Dexamethasone intravitreal implant (OZURDEX®) as prescribed in clinical practice.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Patient with Diabetic Macular Edema (DME) treated with Ozurdex® in clinical practice.
Exclusion criteria
-Patient not residing in metropolitan France.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Time to Achieve Maximum Gain in BCVA | 24 Months |
| 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 |
| 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 |
Countries
France
Outcome results
None listed