NCT07423442

Frequency and Intensity of Inflammatory Relapses in Patients With Non-infectious Posterior Uveitis Treated With a Fluocinolone Acetonide Implant

Frequency and Intensity of REcurrences in Non-infectious Posterior Uveitis Treated With Fluocinolone Acetonide Implant (FACi): a Multicenter Retrospective Real-world Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Non-infectious posterior uveitis is a chronic inflammatory eye disease that can lead to irreversible retinal damage and visual impairment due to repeated inflammatory relapses. The fluocinolone acetonide intravitreal implant is approved for the prevention of inflammatory relapses in this condition, but data from real-world clinical practice remain limited, particularly regarding the intensity of relapses over time. This multicenter retrospective observational study aims to evaluate the frequency and intensity of inflammatory recurrences in adult patients with non-infectious posterior uveitis treated with a fluocinolone acetonide implant. Clinical and imaging data routinely collected during follow-up will be analyzed over a three-year period to better characterize long-term outcomes, treatment burden, and safety in real-life conditions.

Detailed description

This is a multicenter, retrospective, real-world observational study conducted in ophthalmology departments of several French university and general hospitals. The study includes adult patients with non-infectious posterior uveitis or persistent posterior segment inflammation who received a fluocinolone acetonide intravitreal implant as part of routine clinical care. All treatments were prescribed independently of the study, and no intervention was assigned by the investigators. Data are collected retrospectively from medical records and include clinical, functional, and imaging parameters routinely used in uveitis follow-up. The primary objective is to assess the intensity of inflammatory relapses before and after implantation by analyzing variations in best corrected visual acuity, central macular thickness, and laser flare measurements over predefined time periods. Secondary objectives include evaluation of relapse frequency, retreatment burden, changes in systemic anti-inflammatory or immunosuppressive therapies, identification of predictive factors associated with relapse severity, and assessment of the long-term safety profile of the fluocinolone acetonide implant in real-life practice. Data are pseudonymized and recorded in a secure electronic database hosted by the sponsor institution, in compliance with applicable data protection regulations. Analyses are primarily descriptive, reflecting the observational nature of the study. This study is conducted in accordance with French regulations for non-interventional research and aims to provide complementary real-world evidence to existing clinical trial data on the long-term management of non-infectious posterior uveitis.

Conditions

• Noninfectious Posterior Uveitis
• Uveitis, Posterior
• Uveitic Macular Edema

Interventions

Type	Name	Description
DRUG	fluocinolone acetonide intravitreal implant	Intravitreal corticosteroid implant delivering fluocinolone acetonide, administered as part of routine clinical management for the prevention of inflammatory relapses and macular edema in non-infectious posterior uveitis. Treatment decisions were made independently of the study.

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2026-02-20
• Last updated: 2026-02-20