Study of Risk Factors for Therapeutic Failure in Chronic Non-Infectious Uveitis After First-Line Immunosuppressive Therapy

Active, not recruiting

• Conditions: Uveitis

• Registration Number: NCT06821971
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

Uveitis is an inflammatory disease of the uvea, constituting the 4th leading cause of legal blindness worldwide and the 3rd leading cause of avoidable blindness . It is not a rare condition, with an incidence of 17 to 52 per 100,000 population and a prevalence of 38 to 204 per 100,000 population. In the case of cortico-dependence, it is generally accepted to propose sparing with a conventional immunosuppressant, whose efficacy is estimated at around 70%, compared with biotherapies, which are considered more effective (over 90%) but only available as 2nd-line treatment. However, there are few studies on the failure factors of this first-line treatment, such as macular thickness , gender, or vitamin D deficiency. Risk factors for flare-ups are nevertheless known, notably ethnicity, and smoking. The aim of this study is to identify risk factors for treatment failure after three months of first-line immunosuppressive therapy in patients with chronic non-infectious uveitis at Amiens-Picardie University Hospital.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-14
• Study First Submitted: 2025-01-28
• Study First Submitted QC: 2025-02-11
• Study First Posted: 2025-02-12
• Primary Completion: 2025-03-01
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age : > 18 years old
• Uveitis requiring immunosuppressive therapy.
• Including at least one posterior involvement according to the SUN terminology: posterior, or intermediate and posterior, or anterior and posterior, or panuveitis.

Exclusion Criteria

• Uveitis associated with multiple sclerosis or systemic lupus erythematosus.
• Ocular involvement in Behcet's disease requiring biologic therapy as first-line immunosuppressive treatment.
• Uveitis without posterior segment involvement.
• Infectious uveitis.
• Patients objecting to the use of their personal data for research purposes.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of therapeutic failure at 4 months	4 months	Therapeutic failure at 4 months following the initiation of a first-line immunosuppressant in patients with chronic non-infectious uveitis (CNIU).

Secondary Outcome Measures

Name	Time	Method
Number of therapeutic failure at 9 months	9 months	Therapeutic failure at 9 months following the initiation of a first-line immunosuppressant in patients with chronic non-infectious uveitis (CNIU).

Trial Locations

Locations (1)

CHU Amiens-Picardie; 🇫🇷 Salouel, France