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

NCT02121197 | Completed

• 1 other identifier: ECR-RET-2014-07
• Study Type: observational
• Target: 321
• Locations: 8 countries
• Sites: 25

Brief Summary

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

Conditions

Diabetic Macular Edema

Keywords

Macular Diabetic Edema; Ozurdex; Retrospective; European; Intra-vitreal injections

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Ozurdex DRUG

Also known as: Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Association for Innovation and Biomedical Research on Light and Image: lead
• European Vision Institute Clinical Research Network: collaborator

Study Sites (25)

Department of Ophthalmology, Kuopio University Hospital

Kuopio, 70211, Finland

Location

Department of Ophthalmology, Centre Hospitalier Henri Duffaut,

Avignon, 84902, France

Location

Department of Ophthalmology, Croix Rousse University Hospital

Lyon, 69004, France

Location

Clinical Trial Unit, Department of Ophthalmology, CHU Nord, Aix Marseille University

Marseille, 13015, France

Location

Coscas Eye Clinic

Paris, 75006, France

Location

Department of Ophthalmology Lariboisière Hospital

Paris, 75475, France

Location

Ophthalmology Department, Kaplan Medical Center

Rehovot, 76100, Israel

Location

Department of Ophthalmology Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Ophthalmic Research Unit, Department of Basic Medical Sciences, Neuroscience and Sense Organs

Bari, 7012, Italy

Location

Excellence Eye Research Centre University G. d'Annunzio of Chieti-Pescara

Chieti, 66100, Italy

Location

Department of Ophthalmology University Vita Salute - Scientific Institute of San Raffael

Milan, 20132, Italy

Location

Centre for Clinical Trials, Department of Ophthalmology University of Padova

Padua, 35128, Italy

Location

G.B.Bietti Eye Foundation - IRCCS

Rome, 00198, Italy

Location

Department of Ophthalmology University of Udine

Udine, 33100, Italy

Location

Center for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image

Coimbra, 3000-548, Portugal

Location

Instituto de Retina e Diabetes Ocular de Lisboa (IRL)

Lisbon, 1050-085, Portugal

Location

Ophthalmology Department, Dos de Maig Hospital

Barcelona, 08025, Spain

Location

Hospital Vall d'Hebrón Department of Ophthalmology

Barcelona, 08035, Spain

Location

Instituto de Microcirugia Ocular

Barcelona, 08035, Spain

Location

Vallés Oftalmologia Research

Barcelona, 08195, Spain

Location

Ophthalmology Department, Hospital de LaPaz

Madrid, 28046, Spain

Location

Servicio de Oftalmologia, Hospital Universitario Y Politecnico de la Fe

Valencia, 460, Spain

Location

Retinal Clinic, St Eriks Hospital

Stockholm, SE-11282, Sweden

Location

Ophthalmology Clinical Trials Unit Frimley Park Hospital Foundation Trust

Frimley, GU16 7UJ, United Kingdom

Location

NIHR Moorfields Clinical Research Facility, Moorfields Eye Hospital, NHS Foundation Trust

London, EC1V 2PD, United Kingdom

Location

MeSH Terms

Interventions

Calcium Dobesilate; Dexamethasone

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Anat Loewenstein, Professor

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: April 23, 2014
• Study Start: August 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: May 21, 2018

Record last verified: 2018-05

Locations

FR (5); IT (6); FI (1); PT (2); ES (6); SE (1); IL (2); GB (2)