Clinical trial NCT02121197: Retrospective Trial on the Efficacy and Safety of Intravitreal Ozurdex in Patients With Diabetic Macular Edema.
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Macular Edema
Keywords: Macular Diabetic Edema
Ozurdex
Retrospective
European
Intra-vitreal injections
Lead sponsor: Association for Innovation and Biomedical Research on Light and Image
Sponsor class: OTHER
Collaborators: name: European Vision Institute Clinical Research Network
First posted: 2014-04-23
Enrollment: 321
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Department of Ophthalmology, Kuopio University Hospital
city: Avignon
country: France
facility: Department of Ophthalmology, Centre Hospitalier Henri Duffaut,
city: Lyon
country: France
facility: Department of Ophthalmology, Croix Rousse University Hospital
city: Marseille
country: France
facility: Clinical Trial Unit, Department of Ophthalmology, CHU Nord, Aix Marseille University
city: Paris
country: France
facility: Coscas Eye Clinic
city: Paris
country: France
facility: Department of Ophthalmology Lariboisière Hospital
city: Rehovot
country: Israel
facility: Ophthalmology Department, Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Department of Ophthalmology Tel Aviv Sourasky Medical Center
city: Bari
country: Italy
facility: Ophthalmic Research Unit, Department of Basic Medical Sciences, Neuroscience and Sense Organs
city: Chieti
country: Italy
facility: Excellence Eye Research Centre University G. d'Annunzio of Chieti-Pescara
city: Milan
country: Italy
facility: Department of Ophthalmology University Vita Salute - Scientific Institute of San Raffael
city: Padova
country: Italy
facility: Centre for Clinical Trials, Department of Ophthalmology University of Padova
city: Rome
country: Italy
facility: G.B.Bietti Eye Foundation - IRCCS
city: Udine
country: Italy
facility: Department of Ophthalmology University of Udine
city: Coimbra
country: Portugal
facility: Center for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image
city: Lisboa
country: Portugal
facility: Instituto de Retina e Diabetes Ocular de Lisboa (IRL)
city: Barcelona
country: Spain
facility: Ophthalmology Department, Dos de Maig Hospital
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebrón Department of Ophthalmology
city: Barcelona
country: Spain
facility: Instituto de Microcirugia Ocular
city: Barcelona
country: Spain
facility: Vallés Oftalmologia Research
city: Madrid
country: Spain
facility: Ophthalmology Department, Hospital de LaPaz
city: Valencia
country: Spain
facility: Servicio de Oftalmologia, Hospital Universitario Y Politecnico de la Fe
city: Stockholm
country: Sweden
facility: Retinal Clinic, St Eriks Hospital
city: Frimley
country: United Kingdom
facility: Ophthalmology Clinical Trials Unit Frimley Park Hospital Foundation Trust
city: London
country: United Kingdom
facility: NIHR Moorfields Clinical Research Facility, Moorfields Eye Hospital, NHS Foundation Trust
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Anat Loewenstein, Professor
role: PRINCIPAL_INVESTIGATOR
References: