Ozurdex® in Patients With Non-infectious Uveitis Affecting the Posterior Segment of the Eye

Terminated

• Conditions: Non-infectious Uveitis
• Interventions: Drug: dexamethasone intravitreal implant

• Registration Number: NCT02951975
• Lead Sponsor: Allergan

Brief Summary

This observational study will evaluate the safety, efficacy, characteristics of patients, characteristics of physicians and quality of life in patients who are prescribed OZURDEX® as treatment for non-infectious uveitis of the posterior segment of the eye in France.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-31
• Study First Submitted QC: 2016-10-31
• Study First Posted: 2016-11-01
• Study Start: 2017-01-25
• Primary Completion: 2018-11-28
• Study Completion: 2018-12-19
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-31
• Last Update Posted: 2019-08-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 246

Inclusion Criteria

-Patient with non-infectious uveitis affecting the posterior segment of the eye.

Exclusion Criteria

-Patient not residing in metropolitan France.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OZURDEX®	dexamethasone intravitreal implant	Patients prescribed dexamethasone intravitreal implant (OZURDEX®) in clinical practice for the treatment of non-infectious uveitis affecting the posterior segment of the eye.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Best Corrected Visual Acuity (BCVA) ≥15 Letters	2 Months

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants with a Gain (Improvement) in BCVA of at Least 15 Letters from Baseline	Baseline, Months 6 and 18
Change from Baseline in Vitreous Haze Score Using a 5-Point Scale	Baseline and Months 2, 6 and 18
Change from Baseline in Macular Thickness	Baseline, Months 2, 6 and 18
Percentage of Participants Categorized by Comorbidities (Diseases Associated with Inflammation, Other Ophthalmic Diseases, General Comorbidities)	18 Months
Change from Baseline in the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ25) Score Using a 25 Item Questionnaire	Baseline, Months 2 and 18
Change from Baseline in BCVA	Baseline, Months 2, 6 and 18
Percentage of Participants with Adverse Events (AEs)	18 Months
Number of Repeat Treatments with OZURDEX® and Other Drugs	18 Months
Time Between Repeat Treatments with OZURDEX® and Other Drugs	18 Months

Trial Locations

Locations (21)

IOP Institut Ophtalmologique de Picardie; 🇫🇷 Amiens, France

CHU Amiens; 🇫🇷 Amiens, France

Hopital Hotel Dieu Et Hme; 🇫🇷 Nantes, France

SEL Ophtalliance; 🇫🇷 Nantes, France

Hôpital Lariboisière (AP-HP); 🇫🇷 Paris, France

Hopital Pellegrin; 🇫🇷 Bordeaux, France

Hopital de la Timone; 🇫🇷 Marseille, France

Hopital Gui De Chauliac; 🇫🇷 Montpellier, France

CHU Pasteur 2; 🇫🇷 Nice, France

Centre Rétine Gallien; 🇫🇷 Bordeaux, France

CHI de Créteil; 🇫🇷 Creteil, France

CHU Dijon; 🇫🇷 Dijon, France

Hopital De La Croix Rousse; 🇫🇷 Lyon, France

Centre Pôle Vision Val d'Ouest; 🇫🇷 Ecully, France

Hopital Claude Huriez; 🇫🇷 Lille, France

GH Pitie Salpêtrière (AP-HP); 🇫🇷 Paris, France

Clinique Monticelli; 🇫🇷 Marseille, France

Hopital La Milétrie; 🇫🇷 Poitiers, France

GH Cochin St Vincent De Paul (AP-HP); 🇫🇷 Paris, France

Fondation Rothschild; 🇫🇷 Paris, France

Chu Toulouse; 🇫🇷 Toulouse, France