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

Allergan

Status and phase

Completed

Phase 4

Conditions

Diabetic Macular Edema

Treatments

Drug: Dexamethasone Intravitreal Implant

Study type

Interventional

Funder types

Industry

Identifiers

NCT03953807

CMO-MA-EYE-0603

2018-004785-33 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

82 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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