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.

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

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/