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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02121197

Acronym

ARTES

Enrollment

321

Registered

2014-04-23

Start date

2014-08-31

Completion date

2016-01-31

Last updated

2018-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema

Keywords

Macular Diabetic Edema, Ozurdex, Retrospective, European, Intra-vitreal injections

Brief summary

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

Interventions

DRUGOzurdex

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.	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.

Countries

Finland, France, Israel, Italy, Portugal, Spain, Sweden, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026