A Study to Evaluate the Effectiveness and Safety of OZURDEX® in Patients With Diabetic Macular Edema But Never Treated

A 12-month, Prospective, Open-label, Phase 4 Study to Evaluate the Efficacy and Safety of OZURDEX® (Dexamethasone Intravitreal Implant) in Treatment Naïve Patients (According to Standard Clinical Practice) With Diabetic Macular Edema

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