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

Sponsor
Association for Innovation and Biomedical Research on Light and Image (Other)
Overall Status
Completed
CT.gov ID
NCT02121197
Collaborator
European Vision Institute Clinical Research Network (Other)
321
25
17
12.8
0.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
321 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official 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)
Study Start Date :
Aug 1, 2014
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Jan 1, 2016

Outcome Measures

Primary Outcome Measures

  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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Association for Innovation and Biomedical Research on Light and Image
  • European Vision Institute Clinical Research Network

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier:
NCT02121197
Other Study ID Numbers:
  • ECR-RET-2014-07
First Posted:
Apr 23, 2014
Last Update Posted:
May 21, 2018
Last Verified:
May 1, 2018
Keywords provided by Association for Innovation and Biomedical Research on Light and Image
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 21, 2018