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CompletedNCT02121197ARTESUpdated May 21, 2018

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

An observational study in Diabetic Macular Edema, sponsored by Association for Innovation and Biomedical Research on Light and Image. Completed at 25 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-21.

Sponsored by Association for Innovation and Biomedical Research on Light and Image · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
321
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Diabetic Macular Edema

Keywords

  • Macular Diabetic Edema
  • Ozurdex
  • Retrospective
  • European
  • Intra-vitreal injections
03

In context

Macular Edema

841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.

This study's enrollment of 321 is above the median of 97 across 163 observational studies indexed under Macular Edema.

Browse Macular Edema studies →

Lead sponsor

Association for Innovation and Biomedical Research on Light and Image is the lead sponsor of 38 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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).

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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
321 participants (actual)
Patient registry
No

Interventions

  • DrugOzurdex

    Also known as: Dexamethasone

06

What researchers measure

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.

    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

07

Study locations

25 sites
  • Department of Ophthalmology, Kuopio University Hospital
    Kuopio, 70211, Finland
  • Department of Ophthalmology, Centre Hospitalier Henri Duffaut,
    Avignon, 84902, France
  • Department of Ophthalmology, Croix Rousse University Hospital
    Lyon, 69004, France
  • Clinical Trial Unit, Department of Ophthalmology, CHU Nord, Aix Marseille University
    Marseille, 13015, France
  • Coscas Eye Clinic
    Paris, 75006, France
  • Department of Ophthalmology Lariboisière Hospital
    Paris, 75475, France
  • Ophthalmology Department, Kaplan Medical Center
    Rehovot, 76100, Israel
  • Department of Ophthalmology Tel Aviv Sourasky Medical Center
    Tel Aviv, 64239, Israel
  • Ophthalmic Research Unit, Department of Basic Medical Sciences, Neuroscience and Sense Organs
    Bari, 7012, Italy
  • Excellence Eye Research Centre University G. d'Annunzio of Chieti-Pescara
    Chieti, 66100, Italy
  • Department of Ophthalmology University Vita Salute - Scientific Institute of San Raffael
    Milan, 20132, Italy
  • Centre for Clinical Trials, Department of Ophthalmology University of Padova
    Padova, 35128, Italy
  • G.B.Bietti Eye Foundation - IRCCS
    Rome, 00198, Italy
  • Department of Ophthalmology University of Udine
    Udine, 33100, Italy
  • Center for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image
    Coimbra, 3000-548, Portugal
  • Instituto de Retina e Diabetes Ocular de Lisboa (IRL)
    Lisboa, 1050-085, Portugal
  • Ophthalmology Department, Dos de Maig Hospital
    Barcelona, 08025, Spain
  • Hospital Vall d'Hebrón Department of Ophthalmology
    Barcelona, 08035, Spain
  • Instituto de Microcirugia Ocular
    Barcelona, 08035, Spain
  • Vallés Oftalmologia Research
    Barcelona, 08195, Spain
  • Ophthalmology Department, Hospital de LaPaz
    Madrid, 28046, Spain
  • Servicio de Oftalmologia, Hospital Universitario Y Politecnico de la Fe
    Valencia, 460, Spain
  • Retinal Clinic, St Eriks Hospital
    Stockholm, SE-11282, Sweden
  • Ophthalmology Clinical Trials Unit Frimley Park Hospital Foundation Trust
    Frimley, GU16 7UJ, United Kingdom
  • NIHR Moorfields Clinical Research Facility, Moorfields Eye Hospital, NHS Foundation Trust
    London, EC1V 2PD, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02121197
Lead sponsor
Association for Innovation and Biomedical Research on Light and Image
Collaborators
European Vision Institute Clinical Research Network
Responsible party
Sponsor
First posted
Apr 23, 2014
Start date
Aug 2014
Primary completion
Jan 2016
Completion
Jan 2016
Last update
May 21, 2018

Study contacts

Anat Loewenstein, Professor
principal investigator · Tel-Aviv Sourasky Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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