Retrospective Trial on the Efficacy and Safety of Intravitreal Ozurdex in Patients With Diabetic Macular Edema.
NCT ID: NCT02121197
Last Updated: 2018-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
321 participants
OBSERVATIONAL
2014-08-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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Ozurdex
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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European Vision Institute Clinical Research Network
NETWORK
Association for Innovation and Biomedical Research on Light and Image
OTHER
Responsible Party
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Principal Investigators
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Anat Loewenstein, Professor
Role: PRINCIPAL_INVESTIGATOR
Tel-Aviv Sourasky Medical Center
Locations
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Department of Ophthalmology, Kuopio University Hospital
Kuopio, , Finland
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, , France
Ophthalmology Department, Kaplan Medical Center
Rehovot, , Israel
Department of Ophthalmology Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
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
Padua, , Italy
G.B.Bietti Eye Foundation - IRCCS
Rome, , Italy
Department of Ophthalmology University of Udine
Udine, , Italy
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)
Lisbon, , Portugal
Ophthalmology Department, Dos de Maig Hospital
Barcelona, , Spain
Hospital Vall d'Hebrón Department of Ophthalmology
Barcelona, , Spain
Instituto de Microcirugia Ocular
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, , Spain
Retinal Clinic, St Eriks Hospital
Stockholm, , Sweden
Ophthalmology Clinical Trials Unit Frimley Park Hospital Foundation Trust
Frimley, , United Kingdom
NIHR Moorfields Clinical Research Facility, Moorfields Eye Hospital, NHS Foundation Trust
London, , United Kingdom
Countries
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Other Identifiers
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ECR-RET-2014-07
Identifier Type: -
Identifier Source: org_study_id
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