Clinical effectiveness of the 0.18 mg fluocinolone acetonide intravitreal implant for non-infectious uveitis-associated macular edema: a real-world study

0.18 mg 氟轻松玻璃体内植入剂治疗非感染性葡萄膜炎相关性黄斑水肿的临床疗效:一项真实世界研究

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Abstract

OBJECTIVE: To evaluate the real-world clinical effectiveness and safety of the 0.18 mg fluocinolone acetonide intravitreal implant (FAi) in Chinese patients with macular edema (ME) secondary to non-infectious uveitis (NIU). METHODS: This single-center, retrospective case series included patients diagnosed with NIU-associated ME who received an intravitreal 0.18 mg FAi injection between January and September, 2024 and completed at least 12 months of follow-up. Primary outcome measures were changes in best-corrected visual acuity (BCVA, converted to logMAR), intraocular pressure (IOP), central macular thickness (CMT), and subfoveal choroidal thickness (SFCT) from baseline to 1, 3, 6, and 12 months post-treatment, analyzed using a linear mixed model. Inflammatory recurrence and treatment-related adverse events were also documented. RESULTS: A total of 39 patients (50 eyes) were included, with a mean age of 54.6 ± 14.8 years. The mean baseline BCVA was 0.65 ± 0.33 logMAR, and the mean CMT was 333.4 ± 108.6 μm. BCVA demonstrated significant improvement at all postoperative time points compared to baseline (all P< 0.001), reaching 0.48 ± 0.31 logMAR at 12 months. CMT showed a significant and sustained reduction postoperatively (all P< 0.001), decreasing to 239.7 ± 54.4 μm at 12 months. SFCT also decreased significantly from baseline (all P< 0.001). Postoperative IOP was significantly higher than baseline (P= 0.008, P= 0.001, P< 0.001, P< 0.001). Postoperative IOP elevation was observed in 18 eyes (36%). Management strategies included topical anti-glaucoma medication in 12 eyes and laser therapy in 3 eyes (1 selective laser trabeculoplasty and 2 diode laser cyclophotocoagulation). Notably, 3 eyes (6%) required trabeculectomy due to uncontrolled IOP. The inflammation recurrence rate during the 12-month follow-up was 14% (7/50 eyes). Implant migration into the anterior chamber occurred in one eye. No other serious ocular complications or systemic adverse events were observed. CONCLUSION: In this real-world study, the 0.18 mg FAi effectively improved visual acuity, reduced ME, and attenuated choroidal thickening in Chinese patients with NIU-associated ME over 12 months. The primary risk was manageable IOP elevation, resulting in an overall favorable safety profile. The 0.18 mg FAi represents an effective long-term treatment option for this patient population. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at10.1186/s12886-026-04661-8.

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