Retrospective Trial on the Efficacy and Safety of Intravitreal Ozurdex in Patients With Diabetic Macular Edema. (ARTES)

Association for Innovation and Biomedical Research on Light and Image

Status: Completed

Conditions: Diabetic Macular Edema

Treatments: Drug: Ozurdex

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT02121197

ECR-RET-2014-07

Details and patient eligibility

About

To review the safety and efficacy of injections with Ozurdex (700 μg dexamethasone) in clinical practice management of patients with DME.

Enrollment: 321 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults (≥18 years) with diabetes
• DME in the study eye (if both eyes have DME both eyes will be included in analysis)
• BCVA minimum of 20/200 (35 letters)
• Central Macular Thickness (CMT) ≥300 µm
• Patients with DME who were treated with Ozurdex at least twice (baseline is before the first Ozurdex injection).
• Follow up of at least 6 months after the last Ozurdex injection given
• Complete records including BCVA (OCT and Fluorescein Angiography (FA) if available) throughout the follow up

Exclusion criteria

• Patients with ME not secondary to Diabetes Mellitus (DM).
• Presence of other retinopathies (AMD, RVO) or visually significant ocular morbidity (e.g. advanced glaucoma, corneal opacity)
• Previous ocular trauma or surgery other than cataract extraction
• Intravitreal triamcinolone ≤6 months before baseline
• Intravitreal bevacizumab, ranibizumab, or pegaptanib <1 months before baseline
• Marked intraocular pressure (IOP) elevation in response to any previous steroid treatment
• Ocular Hypertension (OHT) in the study eye(s)
• IOP >23 mm Hg without antiglaucoma medication
• IOP >21 mm Hg with one antiglaucoma medication
• Use of 2 or more antiglaucoma medications
• Glaucoma - Visual Fields (VF) defect > 4 dB