Study Stopped
Business decision to stop the program.
Ozurdex® in Patients With Non-infectious Uveitis Affecting the Posterior Segment of the Eye
Louvre 2
Multicentre Longitudinal Study of the Prescription of Ozurdex® in Patients With Non-infectious Uveitis Affecting the Posterior Segment of the Eye
1 other identifier
observational
246
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2017
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2016
CompletedFirst Posted
Study publicly available on registry
November 1, 2016
CompletedStudy Start
First participant enrolled
January 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2018
CompletedAugust 2, 2019
July 1, 2019
1.8 years
October 31, 2016
July 31, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants with Best Corrected Visual Acuity (BCVA) ≥15 Letters
2 Months
Secondary Outcomes (9)
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 BCVA
Baseline, Months 2, 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
- +4 more secondary outcomes
Study Arms (1)
OZURDEX®
Patients prescribed dexamethasone intravitreal implant (OZURDEX®) in clinical practice for the treatment of non-infectious uveitis affecting the posterior segment of the eye.
Interventions
Dexamethasone intravitreal implant (OZURDEX®) as prescribed in clinical practice.
Eligibility Criteria
Patients treated with OZURDEX® in clinical practice.
You may qualify if:
- Patient with non-infectious uveitis affecting the posterior segment of the eye.
You may not qualify if:
- Patient not residing in metropolitan France.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (21)
CHU Amiens
Amiens, 80000, France
IOP Institut Ophtalmologique de Picardie
Amiens, 80000, France
Centre Rétine Gallien
Bordeaux, 33000, France
Hopital Pellegrin
Bordeaux, 33076, France
CHI de Créteil
Créteil, 94000, France
CHU Dijon
Dijon, 21079, France
Centre Pôle Vision Val d'Ouest
Écully, 69130, France
Hopital Claude Huriez
Lille, 59037, France
Hopital De La Croix Rousse
Lyon, 69317, France
Clinique Monticelli
Marseille, 13 008, France
Hopital de la Timone
Marseille, 13385, France
Hopital Gui De Chauliac
Montpellier, 34000, France
SEL Ophtalliance
Nantes, 44000, France
Hopital Hotel Dieu Et Hme
Nantes, 44093, France
CHU Pasteur 2
Nice, 06000, France
Hôpital Lariboisière (AP-HP)
Paris, 75010, France
GH Pitie Salpêtrière (AP-HP)
Paris, 75013, France
GH Cochin St Vincent De Paul (AP-HP)
Paris, 75014, France
Fondation Rothschild
Paris, 75019, France
Hopital La Milétrie
Poitiers, 86021, France
Chu Toulouse
Toulouse, 31000, France
Related Publications (1)
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.
PMID: 35802252DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nathalie Mesnard
Allergan
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2016
First Posted
November 1, 2016
Study Start
January 25, 2017
Primary Completion
November 28, 2018
Study Completion
December 19, 2018
Last Updated
August 2, 2019
Record last verified: 2019-07