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NCT Number: NCT06821971

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens-Picardie

Salouël, 80480, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of therapeutic failure at 4 months

    Time frame: 4 months

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

Secondary outcomes

  1. Number of therapeutic failure at 9 months

    Time frame: 9 months

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: FAIL-UVEITIS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2025
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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