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Completed

NCT Number: NCT02121197

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

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

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Key information

Conditions

Diabetic Macular Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology, Kuopio University Hospital, Kuopio, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ozurdex

Drug

Other names: Dexamethasone

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Association for Innovation and Biomedical Research on Light and Image

Other

Collaborators

  • European Vision Institute Clinical Research Network

Registry information

Official study title

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)

Acronym: ARTES

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 23, 2014
Registry last updated
May 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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