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

May 17, 2018 updated by: Association for Innovation and Biomedical Research on Light and Image

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

321

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kuopio, Finland, 70211
        • Department of Ophthalmology, Kuopio University Hospital
  • France
      • Avignon, France, 84902
        • Department of Ophthalmology, Centre Hospitalier Henri Duffaut,
      • Lyon, France, 69004
        • Department of Ophthalmology, Croix Rousse University Hospital
      • Marseille, France, 13015
        • Clinical Trial Unit, Department of Ophthalmology, CHU Nord, Aix Marseille University
      • Paris, France, 75006
        • Coscas Eye Clinic
      • Paris, France, 75475
        • Department of Ophthalmology Lariboisière Hospital
  • Israel
      • Rehovot, Israel, 76100
        • Ophthalmology Department, Kaplan Medical Center
      • Tel Aviv, Israel, 64239
        • Department of Ophthalmology Tel Aviv Sourasky Medical Center
  • Italy
      • Bari, Italy, 7012
        • Ophthalmic Research Unit, Department of Basic Medical Sciences, Neuroscience and Sense Organs
      • Chieti, Italy, 66100
        • Excellence Eye Research Centre University G. d'Annunzio of Chieti-Pescara
      • Milan, Italy, 20132
        • Department of Ophthalmology University Vita Salute - Scientific Institute of San Raffael
      • Padova, Italy, 35128
        • Centre for Clinical Trials, Department of Ophthalmology University of Padova
      • Rome, Italy, 00198
        • G.B.Bietti Eye Foundation - IRCCS
      • Udine, Italy, 33100
        • Department of Ophthalmology University of Udine
  • Portugal
      • Coimbra, Portugal, 3000-548
        • Center for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image
      • Lisboa, Portugal, 1050-085
        • Instituto de Retina e Diabetes Ocular de Lisboa (IRL)
  • Spain
      • Barcelona, Spain, 08035
        • Instituto de Microcirugia Ocular
      • Barcelona, Spain, 08025
        • Ophthalmology Department, Dos de Maig Hospital
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebrón Department of Ophthalmology
      • Barcelona, Spain, 08195
        • Vallés Oftalmologia Research
      • Madrid, Spain, 28046
        • Ophthalmology Department, Hospital de LaPaz
      • Valencia, Spain, 460
        • Servicio de Oftalmologia, Hospital Universitario Y Politecnico de la Fe
  • Sweden
      • Stockholm, Sweden, SE-11282
        • Retinal Clinic, St Eriks Hospital
  • United Kingdom
      • Frimley, United Kingdom, GU16 7UJ
        • Ophthalmology Clinical Trials Unit Frimley Park Hospital Foundation Trust
      • London, United Kingdom, EC1V 2PD
        • NIHR Moorfields Clinical Research Facility, Moorfields Eye Hospital, NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

300-400 patients who have received at least 2 Ozurdex injections for the treatment of DME, were followed for at least 6 months after the last injection and with a minimal BCVA of 20/200 at baseline (before Ozurdex treatment).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association for Innovation and Biomedical Research on Light and Image

Collaborators

European Vision Institute Clinical Research Network

Investigators

  • Principal Investigator: Anat Loewenstein, Professor, Tel-Aviv Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

April 22, 2014

First Submitted That Met QC Criteria

April 22, 2014

First Posted (Estimate)

April 23, 2014

Study Record Updates

Last Update Posted (Actual)

May 21, 2018

Last Update Submitted That Met QC Criteria

May 17, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECR-RET-2014-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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