Multicentre Longitudinal Study of the Prescription of Ozurdex® in Patients With Non-infectious Uveitis Affecting the Posterior Segment of the Eye

Allergan21 sites in 1 country246 target enrollmentJanuary 25, 2017

ConditionsNon-infectious Uveitis

Interventionsdexamethasone intravitreal implant

Drugsdexamethasone intravitreal implant

Overview

Phase: N/A
Intervention: dexamethasone intravitreal implant
Conditions: Non-infectious Uveitis
Sponsor: Allergan
Enrollment: 246
Locations: 21
Primary Endpoint: Percentage of Participants with Best Corrected Visual Acuity (BCVA) ≥15 Letters
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 25, 2017

End Date

December 19, 2018

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Allergan

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Patient not residing in metropolitan France.

Arms & Interventions

OZURDEX®

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

Intervention: dexamethasone intravitreal implant

Outcomes

Primary Outcomes

Percentage of Participants with Best Corrected Visual Acuity (BCVA) ≥15 Letters

Time Frame: 2 Months

Secondary Outcomes

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)
Number of Repeat Treatments with OZURDEX® and Other Drugs(18 Months)
Time Between Repeat Treatments with OZURDEX® and Other Drugs(18 Months)
Percentage of Participants with Adverse Events (AEs)(18 Months)