Noninfectious Posterior Uveitis, Uveitic Macular Edema, Uveitis, Posterior
Conditions
Brief summary
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.
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.
Interventions
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.
Sponsors
Nantes University Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of inflammatory recurrences after fluocinolone acetonide implant | 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
| Measure | Time frame | Description |
|---|---|---|
| Frequency of inflammatory recurrences and retreatments | 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. |
| Change in systemic anti-inflammatory and immunosuppressive treatment burden | 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. |
| Safety outcomes related to intraocular pressure and ocular complications | 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. |
| Peripapillary retinal nerve fiber layer changes | Baseline 12, 24, and 36 months after implantation | Changes in peripapillary retinal nerve fiber layer thickness measured by optical coherence tomography in predefined sectors. |
Countries
France
Contacts
CONTACTJean Baptiste DUCLOYER, MD, PhD
CONTACTAlexandra Poinas, PhD
Outcome results
None listed