Macular Edema
Conditions
Brief summary
This is a study of OZURDEX® use in clinical practice in patients with diabetic macular edema (DME).
Interventions
Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Diabetic Macular Edema. All decisions regarding treatment are made at the sole discretion of the treating physician in accordance with their usual practices.
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
* Diagnosis of DME in at least one eye treated OZURDEX® per clinical practice
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline, 12 Months |
| Percentage of Patients with a BCVA Improvement of ≥15 Letters in the Study Eye | Baseline, 12 Months |
| Average Change from Baseline in BCVA in the Study Eye | Baseline, 12 Months |
Secondary
| Measure | Time frame |
|---|---|
| Mean Number of Ozurdex Injections in the Study Eye | 12 Months |
| Percentage of Patients with an Increase from Baseline of ≥2 Lines in BCVA in the Study Eye | Baseline, 12 Months |
| Change from Baseline in Central Retinal Subfield Thickness (CRT) in the Study Eye | Baseline, 12 Months |
| Mean Time Between Ozurdex Injections in the Study Eye | 12 Months |
| Percentage of Patients with an Increase from Baseline of ≥3 Lines in BCVA in the Study Eye | Baseline, 12 Months |
| Percentage of Patients with BCVA of 20/40 or Better in the Study Eye | Baseline, 12 Months |
Countries
United States
Outcome results
None listed