A Collaborative Retrospective Trial on the Efficacy and Safety of Intravitreal Dexamethasone Implant (Ozurdex) in Patients With Diabetic Macular Edema (DME). THE EUROPEAN DME REGISTRAR STUDY (ARTES)

Association for Innovation and Biomedical Research on Light and Image25 sites in 8 countries321 target enrollmentAugust 2014

ConditionsDiabetic Macular Edema

DrugsOzurdex

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetic Macular Edema
Sponsor: Association for Innovation and Biomedical Research on Light and Image
Enrollment: 321
Locations: 25
Primary Endpoint: Percentage of patients with Best Corrected Visual Acuity (BCVA) from baseline to 4 - 6 months after last injection, with comparison between early (<9 month duration of DME) vs late (≥9 month duration of DME), and naïve vs previously treated patients.
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

January 2016

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Association for Innovation and Biomedical Research on Light and Image

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Percentage of patients with Best Corrected Visual Acuity (BCVA) from baseline to 4 - 6 months after last injection, with comparison between early (<9 month duration of DME) vs late (≥9 month duration of DME), and naïve vs previously treated patients.

Time Frame: 6 month

Percentage of patients with Best Corrected Visual Acuity (BCVA) from baseline to 4 - 6 months after last injection, with comparison between early (\<9 month duration of DME) vs late (≥9 month duration of DME), and naïve vs previously treated patients.