An observational study in Noninfectious Posterior Uveitis, Uveitis, Posterior and Uveitic Macular Edema, sponsored by Nantes University Hospital. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Nantes University Hospital · Observational
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.
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.
61 studies on the registry are indexed under Uveitis, Posterior; 4 are open to participants now.
This study's planned enrollment of 100 is above the median of 42 across 10 observational studies indexed under Uveitis, Posterior.
Browse Uveitis, Posterior studies →Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.
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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.
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Exclusion Criteria:
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.
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
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
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
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
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
Start is estimated for Jun 2026; primary completion for Jan 2027, 7 months later.
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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