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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Uveitis, Posterior; Uveitic Macular Edema; Noninfectious Posterior Uveitis
• Intervention / Treatment: Drug: fluocinolone acetonide intravitreal implant

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Alexandra Poinas, PhD; Phone Number: +33 2 53 48 28 57; Email: alexandra.poinas@chu-nantes.fr
• Study Contact Backup: Name: Jean Baptiste DUCLOYER, MD, PhD; Phone Number: 02 40 08 34 01; Email: jeanbaptiste.ducloyer@chu-nantes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients followed in ophthalmology departments of participating French university and general hospitals for non-infectious posterior uveitis or persistent posterior segment inflammation and treated with a fluocinolone acetonide intravitreal implant as part of routine clinical care.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
FACi-treated cohort; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of inflammatory recurrences after fluocinolone acetonide implant	Intensity of inflammatory recurrences assessed as the delta between the highest and lowest values of best corrected visual acuity (ETDRS letters), central macular thickness of the central 1000 µm (µm), and laser flare meter values within predefined time periods before and after implantation.	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

Outcome Measure	Measure Description	Time Frame
Frequency of inflammatory recurrences and retreatments	Number and timing of local retreatments for uveitic macular edema, including intravitreal dexamethasone implants and subconjunctival triamcinolone injections, before and up to 36 months after fluocinolone acetonide implantation.	Year -1 before implantation 0 to 36 months after implantation
Change in systemic anti-inflammatory and immunosuppressive treatment burden	Type and dosage of systemic anti-inflammatory and immunosuppressive treatments recorded at baseline and during follow-up after fluocinolone acetonide implantation.	Baseline (implantation) 12, 24, and 36 months after implantation
Safety outcomes related to intraocular pressure and ocular complications	Occurrence of intraocular pressure elevation and other ocular adverse events, including need for hypotensive treatment, laser trabeculoplasty, surgery, cataract, retinal detachment, endophthalmitis, or intravitreal hemorrhage.	0 to 36 months after implantation
Peripapillary retinal nerve fiber layer changes	Changes in peripapillary retinal nerve fiber layer thickness measured by optical coherence tomography in predefined sectors.	Baseline 12, 24, and 36 months after implantation

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: February 13, 2026
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Panuveitis; Uveitis; Uveitis, Posterior; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Fluocinolone Acetonide
• Other Study ID Numbers: AP_JBD_SG_fire

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No