Clinical trial NCT02951975: Ozurdex® in Patients With Non-infectious Uveitis Affecting the Posterior Segment of the Eye
Official title: Multicentre Longitudinal Study of the Prescription of Ozurdex® in Patients With Non-infectious Uveitis Affecting the Posterior Segment of the Eye
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Non-infectious Uveitis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2016-11-01
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated with OZURDEX® in clinical practice.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-Patient not residing in metropolitan France.

Primary outcomes:
measure: Percentage of Participants with Best Corrected Visual Acuity (BCVA) ≥15 Letters
timeFrame: 2 Months
Secondary outcomes:
measure: Percentage of Participants with a Gain (Improvement) in BCVA of at Least 15 Letters from Baseline
timeFrame: Baseline, Months 6 and 18
measure: Change from Baseline in BCVA
timeFrame: Baseline, Months 2, 6 and 18
measure: Change from Baseline in Vitreous Haze Score Using a 5-Point Scale
timeFrame: Baseline and Months 2, 6 and 18
measure: Change from Baseline in Macular Thickness
timeFrame: Baseline, Months 2, 6 and 18
measure: Percentage of Participants Categorized by Comorbidities (Diseases Associated with Inflammation, Other Ophthalmic Diseases, General Comorbidities)
timeFrame: 18 Months
measure: Change from Baseline in the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ25) Score Using a 25 Item Questionnaire
timeFrame: Baseline, Months 2 and 18
measure: Number of Repeat Treatments with OZURDEX® and Other Drugs
timeFrame: 18 Months
measure: Time Between Repeat Treatments with OZURDEX® and Other Drugs
timeFrame: 18 Months
measure: Percentage of Participants with Adverse Events (AEs)
timeFrame: 18 Months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Amiens
country: France
facility: IOP Institut Ophtalmologique de Picardie
city: Bordeaux
country: France
facility: Centre Rétine Gallien
city: Bordeaux
country: France
facility: Hopital Pellegrin
city: Creteil
country: France
facility: CHI de Créteil
city: Dijon
country: France
facility: CHU Dijon
city: Ecully
country: France
facility: Centre Pôle Vision Val d'Ouest
city: Lille
country: France
facility: Hopital Claude Huriez
city: Lyon
country: France
facility: Hopital De La Croix Rousse
city: Marseille
country: France
facility: Clinique Monticelli
city: Marseille
country: France
facility: Hopital de la Timone
city: Montpellier
country: France
facility: Hopital Gui De Chauliac
city: Nantes
country: France
facility: SEL Ophtalliance
city: Nantes
country: France
facility: Hopital Hotel Dieu Et Hme
city: Nice
country: France
facility: CHU Pasteur 2
city: Paris
country: France
facility: Hôpital Lariboisière (AP-HP)
city: Paris
country: France
facility: GH Pitie Salpêtrière (AP-HP)
city: Paris
country: France
facility: GH Cochin St Vincent De Paul (AP-HP)
city: Paris
country: France
facility: Fondation Rothschild
city: Poitiers
country: France
facility: Hopital La Milétrie
city: Toulouse
country: France
facility: Chu Toulouse
Study officials:
affiliation: Allergan
name: Nathalie Mesnard
role: STUDY_DIRECTOR
References:
citation: Bodaghi B, Brezin AP, Weber M, Delcourt C, Kodjikian L, Provost A, Velard ME, Barnier-Ripet D, Pinchinat S, Dupont-Benjamin L. Real-Life Efficacy, Safety, and Use of Dexamethasone Intravitreal Implant in Posterior Segment Inflammation Due to Non-infectious Uveitis (LOUVRE 2 Study). Ophthalmol Ther. 2022 Oct;11(5):1775-1792. doi: 10.1007/s40123-022-00525-8. Epub 2022 Jul 8.