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 volunteersQualifiers
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
Cohort
Retrospective
Treatments tested in this trial
fluocinolone acetonide intravitreal implant
DrugIntravitreal 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
Peripapillary retinal nerve fiber layer changes
Changes in peripapillary retinal nerve fiber layer thickness measured by optical coherence tomography in predefined sectors.
Sponsors and contacts
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