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

NCT06821971 | Active Not Recruiting

• 1 other identifier: PI2025_843_0012
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Uveitis

Keywords

Uveitis

Outcome Measures

Primary Outcomes (1)

• Number of therapeutic failure at 4 months

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

  4 months

Secondary Outcomes (1)

• Number of therapeutic failure at 9 months

  9 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Retrospective cohort study based on medical records of patients who received first-line immunosuppressive (IS) therapy for their uveitis. Patients with chronic non-infectious uveitis at Amiens-Picardie University Hospital, over the period from January 2013 to January 2023.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens-Picardie

Salouël, 80480, France

Location

MeSH Terms

Conditions

Uveitis

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 12, 2025
• Study Start: January 14, 2025
• Primary Completion: March 1, 2025
• Study Completion: August 1, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)