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Non-infectious UveitisLouvre 2NCT02951975

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

An observational study of Non-infectious Uveitis, run by Allergan at 21 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-infectious Uveitis
What is being tested?
dexamethasone intravitreal implant
How many people
246 participants
Where
21 sitesFrance
Study dates
25 Jan 2017to 19 Dec 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients treated with OZURDEX® in clinical practice.

Who may be able to join

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

Who cannot join

  • -Patient not residing in metropolitan France.

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

France21 sites

  • CHU Amiens

    Amiens, 80000

  • IOP Institut Ophtalmologique de Picardie

    Amiens, 80000

  • Centre Rétine Gallien

    Bordeaux, 33000

  • Hopital Pellegrin

    Bordeaux, 33076

  • CHI de Créteil

    Créteil, 94000

  • CHU Dijon

    Dijon, 21079

  • Centre Pôle Vision Val d'Ouest

    Écully, 69130

  • Hopital Claude Huriez

    Lille, 59037

  • Hopital De La Croix Rousse

    Lyon, 69317

  • Clinique Monticelli

    Marseille, 13 008

  • Hopital de la Timone

    Marseille, 13385

  • Hopital Gui De Chauliac

    Montpellier, 34000

  • SEL Ophtalliance

    Nantes, 44000

  • Hopital Hotel Dieu Et Hme

    Nantes, 44093

  • CHU Pasteur 2

    Nice, 06000

  • Hôpital Lariboisière (AP-HP)

    Paris, 75010

  • GH Pitie Salpêtrière (AP-HP)

    Paris, 75013

  • GH Cochin St Vincent De Paul (AP-HP)

    Paris, 75014

  • Fondation Rothschild

    Paris, 75019

  • Hopital La Milétrie

    Poitiers, 86021

  • Chu Toulouse

    Toulouse, 31000

Other trials in France

About this study

Official title: 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.

Being tested
dexamethasone intravitreal implant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dexamethasone intravitreal implantDrug

    Also called OZURDEX®

    Dexamethasone intravitreal implant (OZURDEX®) as prescribed in clinical practice.

Study groups in NCT02951975
Study groupRoleWhat they receive
OZURDEX®Patients prescribed dexamethasone intravitreal implant (OZURDEX®) in clinical practice for the treatment of non-infectious uveitis affecting the posterior segment of the eye.
Receives: Drug: dexamethasone intravitreal implant

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 2 Months

Secondary outcomes (9)

  1. Percentage of Participants with a Gain (Improvement) in BCVA of at Least 15 Letters from Baseline

    Measured: Baseline, Months 6 and 18

  2. Change from Baseline in BCVA

    Measured: Baseline, Months 2, 6 and 18

  3. Change from Baseline in Vitreous Haze Score Using a 5-Point Scale

    Measured: Baseline and Months 2, 6 and 18

  4. Change from Baseline in Macular Thickness

    Measured: Baseline, Months 2, 6 and 18

  5. Percentage of Participants Categorized by Comorbidities (Diseases Associated with Inflammation, Other Ophthalmic Diseases, General Comorbidities)

    Measured: 18 Months

  6. Change from Baseline in the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ25) Score Using a 25 Item Questionnaire

    Measured: Baseline, Months 2 and 18

  7. Number of Repeat Treatments with OZURDEX® and Other Drugs

    Measured: 18 Months

  8. Time Between Repeat Treatments with OZURDEX® and Other Drugs

    Measured: 18 Months

  9. Percentage of Participants with Adverse Events (AEs)

    Measured: 18 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2016 (estimated)
  2. Study start25 Jan 2017
  3. Primary completion28 Nov 2018
  4. Study completion19 Dec 2018

Why it stopped: Business decision to stop the program.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
246 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02951975
Sponsor's protocol ID
GMA-EAME-EYE-0368
Acronym
Louvre 2
Status last verified
Jul 2019
First submitted
31 Oct 2016
Last updated
2 Aug 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 35802252

Questions about this trial

What is this clinical trial studying?

An observational study of Non-infectious Uveitis, run by Allergan at 21 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Business decision to stop the program.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with Best Corrected Visual Acuity (BCVA) ≥15 Letters (time frame: 2 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02951975, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019; AzTrials last refreshed its copy on 6 Nov 2026.

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