ARTES: Retrospective Trial on the Efficacy and Safety of Intravitreal Ozurdex in Patients With Diabetic Macular Edema.
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
Outcome Measures
Primary Outcome Measures
- 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
Inclusion Criteria:
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Adults (≥18 years) with diabetes
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DME in the study eye (if both eyes have DME both eyes will be included in analysis)
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BCVA minimum of 20/200 (35 letters)
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Central Macular Thickness (CMT) ≥300 µm
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Patients with DME who were treated with Ozurdex at least twice (baseline is before the first Ozurdex injection).
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Follow up of at least 6 months after the last Ozurdex injection given
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Complete records including BCVA (OCT and Fluorescein Angiography (FA) if available) throughout the follow up
Exclusion Criteria:
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Patients with ME not secondary to Diabetes Mellitus (DM).
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Presence of other retinopathies (AMD, RVO) or visually significant ocular morbidity (e.g. advanced glaucoma, corneal opacity)
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Previous ocular trauma or surgery other than cataract extraction
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Intravitreal triamcinolone ≤6 months before baseline
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Intravitreal bevacizumab, ranibizumab, or pegaptanib <1 months before baseline
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Marked intraocular pressure (IOP) elevation in response to any previous steroid treatment
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Ocular Hypertension (OHT) in the study eye(s)
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IOP >23 mm Hg without antiglaucoma medication
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IOP >21 mm Hg with one antiglaucoma medication
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Use of 2 or more antiglaucoma medications
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Glaucoma - Visual Fields (VF) defect > 4 dB
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- ECR-RET-2014-07