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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNantes University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Infectious uveitis

Refusal to participate or documented opposition to the study

Follow-up duration shorter than 12 months after implantation

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: FACi-treated cohort1 intervention

Trial outcomes

Primary outcomes

1

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.

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 outcomes

1

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.

Time frame
Year -1 before implantation 0 to 36 months after implantation
2

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.

Time frame
Baseline (implantation) 12, 24, and 36 months after implantation
3

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.

Time frame
0 to 36 months after implantation
4

Peripapillary retinal nerve fiber layer changes

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

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

Other outcomes

Sponsors and contacts

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