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

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). 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. 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. 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.