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

Diabetic Macular Edema Clinical Trial

— ARTES  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02121197
• Other study ID #: ECR-RET-2014-07
• Status: Completed
• Start date: August 2014
• Est. completion date: January 2016

Study information

• Verified date: May 2018
• Source: Association for Innovation and Biomedical Research on Light and Image
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Ozurdex

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Association for Innovation and Biomedical Research on Light and Image	European Vision Institute Clinical Research Network

Countries where clinical trial is conducted

Finland,  France,  Israel,  Italy,  Portugal,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 month