Frequency and Intensity of REcurrences in Non-infectious Posterior Uveitis Treated With Fluocinolone Acetonide Implant (FACi): a Multicenter Retrospective Real-world Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Intensity of inflammatory recurrences after fluocinolone acetonide implant
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Infectious uveitis
- •Refusal to participate or documented opposition to the study
- •Follow-up duration shorter than 12 months after implantation
研究组 & 干预措施
FACi-treated cohort
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.
干预措施: fluocinolone acetonide intravitreal implant (Drug)
结局指标
主要结局
Intensity of inflammatory recurrences after fluocinolone acetonide implant
时间窗: 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.
次要结局
- Frequency of inflammatory recurrences and retreatments(Year -1 before implantation 0 to 36 months after implantation)
- Change in systemic anti-inflammatory and immunosuppressive treatment burden(Baseline (implantation) 12, 24, and 36 months after implantation)
- Safety outcomes related to intraocular pressure and ocular complications(0 to 36 months after implantation)
- Peripapillary retinal nerve fiber layer changes(Baseline 12, 24, and 36 months after implantation)
