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

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Association for Innovation and Biomedical Research on Light and Image
• Collaborator: European Vision Institute Clinical Research Network
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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