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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02951975
Acronym
Louvre 2
Enrollment
246
Registered
2016-11-01
Start date
2017-01-25
Completion date
2018-12-19
Last updated
2019-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-infectious Uveitis

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.

Interventions

DRUGdexamethasone intravitreal implant

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

Sponsors

Allergan
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

-Patient not residing in metropolitan France.

Design outcomes

Primary

MeasureTime frame
Percentage of Participants with Best Corrected Visual Acuity (BCVA) ≥15 Letters2 Months

Secondary

MeasureTime frame
Change from Baseline in BCVABaseline, Months 2, 6 and 18
Change from Baseline in Vitreous Haze Score Using a 5-Point ScaleBaseline and Months 2, 6 and 18
Change from Baseline in Macular ThicknessBaseline, Months 2, 6 and 18
Percentage of Participants Categorized by Comorbidities (Diseases Associated with Inflammation, Other Ophthalmic Diseases, General Comorbidities)18 Months
Percentage of Participants with a Gain (Improvement) in BCVA of at Least 15 Letters from BaselineBaseline, Months 6 and 18
Number of Repeat Treatments with OZURDEX® and Other Drugs18 Months
Time Between Repeat Treatments with OZURDEX® and Other Drugs18 Months
Percentage of Participants with Adverse Events (AEs)18 Months
Change from Baseline in the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ25) Score Using a 25 Item QuestionnaireBaseline, Months 2 and 18

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026