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

CMO-MA-EYE-0603

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.

2019-09-05

2022-07-04

2022-07-04

Completed

Early phase I

82

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 82, 'type': 'ACTUAL'}}

2022-10-07