Diabetic Macular Edema
Conditions
Brief summary
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.
Interventions
DRUGDexamethasone Intravitreal Implant
Implant 700 μg
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | Baseline, at Month 14 | 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. |
| Mean change in Central Retinal Thickness (CRT) 2 months (± 2 weeks) after the last injection received | Baseline, at Month 10 through 12 | — |
| 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 | — |
| Proportion of patients with 2nd injection | During the 12 to 14-month study | — |
Countries
Portugal, Spain
Outcome results
None listed