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

Completed

• Conditions: Diabetic Macular Edema

• Registration Number: NCT02121197
• Lead Sponsor: Association for Innovation and Biomedical Research on Light and Image

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-22
• Study First Submitted QC: 2014-04-22
• Study First Posted: 2014-04-23
• Study Start: 2014-08
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-17
• Last Update Posted: 2018-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 321

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (25)

Ophthalmology Clinical Trials Unit Frimley Park Hospital Foundation Trust; 🇬🇧 Frimley, United Kingdom

Instituto de Microcirugia Ocular; 🇪🇸 Barcelona, Spain

Department of Ophthalmology Lariboisière Hospital; 🇫🇷 Paris, France

Department of Ophthalmology University of Udine; 🇮🇹 Udine, Italy

Ophthalmology Department, Dos de Maig Hospital; 🇪🇸 Barcelona, Spain

G.B.Bietti Eye Foundation - IRCCS; 🇮🇹 Rome, Italy

Coscas Eye Clinic; 🇫🇷 Paris, France

Excellence Eye Research Centre University G. d'Annunzio of Chieti-Pescara; 🇮🇹 Chieti, Italy

Centre for Clinical Trials, Department of Ophthalmology University of Padova; 🇮🇹 Padova, Italy

Servicio de Oftalmologia, Hospital Universitario Y Politecnico de la Fe; 🇪🇸 Valencia, Spain

Hospital Vall d'Hebrón Department of Ophthalmology; 🇪🇸 Barcelona, Spain

Vallés Oftalmologia Research; 🇪🇸 Barcelona, Spain

Instituto de Retina e Diabetes Ocular de Lisboa (IRL); 🇵🇹 Lisboa, Portugal

Department of Ophthalmology, Centre Hospitalier Henri Duffaut,; 🇫🇷 Avignon, France

Department of Ophthalmology, Kuopio University Hospital; 🇫🇮 Kuopio, Finland

Department of Ophthalmology, Croix Rousse University Hospital; 🇫🇷 Lyon, France

Ophthalmic Research Unit, Department of Basic Medical Sciences, Neuroscience and Sense Organs; 🇮🇹 Bari, Italy

Clinical Trial Unit, Department of Ophthalmology, CHU Nord, Aix Marseille University; 🇫🇷 Marseille, France

Ophthalmology Department, Kaplan Medical Center; 🇮🇱 Rehovot, Israel

Department of Ophthalmology Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

Department of Ophthalmology University Vita Salute - Scientific Institute of San Raffael; 🇮🇹 Milan, Italy

Center for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image; 🇵🇹 Coimbra, Portugal

Retinal Clinic, St Eriks Hospital; 🇸🇪 Stockholm, Sweden

Ophthalmology Department, Hospital de LaPaz; 🇪🇸 Madrid, Spain

NIHR Moorfields Clinical Research Facility, Moorfields Eye Hospital, NHS Foundation Trust; 🇬🇧 London, United Kingdom