Frequency and Intensity of Inflammatory Relapses in Patients With Non-infectious Posterior Uveitis Treated With a Fluocinolone Acetonide Implant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: fluocinolone acetonide intravitreal implant.
- Who it may be relevant to
- Registry conditions: Noninfectious Posterior Uveitis, Uveitis, Posterior, Uveitic Macular Edema. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Frequency and Intensity of REcurrences in Non-infectious Posterior Uveitis Treated With Fluocinolone Acetonide Implant (FACi): a Multicenter Retrospective Real-world Study
Overview
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.
Interventions
- 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.
Primary outcome measures
- Intensity of inflammatory recurrences after fluocinolone acetonide implant [Time frame: Year -1 before implantation 0 to 12 months after implantation 12 to 24 months after implantation 24 to 36 months after implantation]
Secondary outcome measures (4)
- Frequency of inflammatory recurrences and retreatments [Time frame: Year -1 before implantation 0 to 36 months after implantation]
- Change in systemic anti-inflammatory and immunosuppressive treatment burden [Time frame: Baseline (implantation) 12, 24, and 36 months after implantation]
- Safety outcomes related to intraocular pressure and ocular complications [Time frame: 0 to 36 months after implantation]
- Peripapillary retinal nerve fiber layer changes [Time frame: Baseline 12, 24, and 36 months after implantation]
Eligibility criteria
Inclusion criteria
- Adult patients aged 18 years or older
- Diagnosis of non-infectious uveitis with posterior segment involvement
- Presence of uveitic macular edema or persistent posterior segment inflammation
- Treatment with a fluocinolone acetonide intravitreal implant prior to January 2024
Exclusion criteria
- Infectious uveitis
- Refusal to participate or documented opposition to the study
- Follow-up duration shorter than 12 months after implantation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- CHU Nantes - Ophthalmology Department — Nantes
Identifiers
NCT: NCT07423442 · AP_JBD_SG_fire