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

• Status: Active, not recruiting
• Trial end date: 2022-08-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate

Criteria

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