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NCT Number: NCT07423442

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

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.

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Key information

Conditions

Noninfectious Posterior Uveitis Eye Diseases Panuveitis Uveal Diseases Uveitic Macular Edema Uveitis Uveitis, Posterior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

fluocinolone acetonide intravitreal implant

Drug

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 outcomes

  1. 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

    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.

Secondary outcomes

  1. Frequency of inflammatory recurrences and retreatments

    Time frame: Year -1 before implantation 0 to 36 months after implantation

    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.

  2. Change in systemic anti-inflammatory and immunosuppressive treatment burden

    Time frame: Baseline (implantation) 12, 24, and 36 months after implantation

    Type and dosage of systemic anti-inflammatory and immunosuppressive treatments recorded at baseline and during follow-up after fluocinolone acetonide implantation.

  3. Safety outcomes related to intraocular pressure and ocular complications

    Time frame: 0 to 36 months after implantation

    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.

  4. Peripapillary retinal nerve fiber layer changes

    Time frame: Baseline 12, 24, and 36 months after implantation

    Changes in peripapillary retinal nerve fiber layer thickness measured by optical coherence tomography in predefined sectors.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Poinas, PhD

CONTACT

[email protected]

+33 2 53 48 28 57

Jean Baptiste DUCLOYER, MD, PhD

CONTACT

[email protected]

02 40 08 34 01

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: FIRE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 20, 2026
Registry last updated
Jun 24, 2026

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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