Ozurdex® in Patients With Non-infectious Uveitis Affecting the Posterior Segment of the Eye (Louvre 2)

July 31, 2019 updated by: Allergan

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

246

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80000
        • CHU Amiens
      • Amiens, France, 80000
        • IOP Institut Ophtalmologique de Picardie
      • Bordeaux, France, 33076
        • Hopital Pellegrin
      • Bordeaux, France, 33000
        • Centre Rétine Gallien
      • Creteil, France, 94000
        • Chi De Creteil
      • Dijon, France, 21079
        • CHU Dijon
      • Ecully, France, 69130
        • Centre Pole Vision Val d'Ouest
      • Lille, France, 59037
        • Hopital Claude Huriez
      • Lyon, France, 69317
        • Hôpital de La Croix Rousse
      • Marseille, France, 13385
        • Hôpital de la Timone
      • Marseille, France, 13 008
        • Clinique Monticelli
      • Montpellier, France, 34000
        • Hôpital Gui de Chauliac
      • Nantes, France, 44000
        • SEL Ophtalliance
      • Nantes, France, 44093
        • Hopital Hotel Dieu Et Hme
      • Nice, France, 06000
        • CHU Pasteur 2
      • Paris, France, 75019
        • Fondation Rothschild
      • Paris, France, 75010
        • Hôpital Lariboisière (AP-HP)
      • Paris, France, 75013
        • GH Pitie Salpêtrière (AP-HP)
      • Paris, France, 75014
        • GH Cochin St Vincent De Paul (AP-HP)
      • Poitiers, France, 86021
        • Hôpital la Milétrie
      • Toulouse, France, 31000
        • CHU Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients treated with OZURDEX® in clinical practice.

Description

Inclusion Criteria:

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

Exclusion Criteria:

-Patient not residing in metropolitan France.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OZURDEX®
Patients prescribed dexamethasone intravitreal implant (OZURDEX®) in clinical practice for the treatment of non-infectious uveitis affecting the posterior segment of the eye.
Drug: dexamethasone intravitreal implant
Dexamethasone intravitreal implant (OZURDEX®) as prescribed in clinical practice.
Other Names:
  • OZURDEX®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Best Corrected Visual Acuity (BCVA) ≥15 Letters
Time Frame: 2 Months
2 Months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2017

Primary Completion (Actual)

November 28, 2018

Study Completion (Actual)

December 19, 2018

Study Registration Dates

First Submitted

October 31, 2016

First Submitted That Met QC Criteria

October 31, 2016

First Posted (Estimate)

November 1, 2016

Study Record Updates

Last Update Posted (Actual)

August 2, 2019

Last Update Submitted That Met QC Criteria

July 31, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMA-EAME-EYE-0368

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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