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Abstract：
OBJECTIVE: This study assessed the effectiveness of the 0.19-mg fluocinolone acetonide (FAc) implant by multimodal measurements in patients with non-infectious uveitis (NIU) in a real-world setting in Spain.
METHODS: A prospective study of patients who had NIU including uveitic macular oedema (UME) with ≥ 12 months follow-up was done. Exclusion criteria include infectious uveitis and uncontrolled glaucoma or ocular hypertension requiring more than 2 medications. Effectiveness was assessed using a multicomponent outcome measure that included nine outcomes. Effectiveness was defined as all components being met at every timepoint. Secondary outcome measures were onset or progression of glaucoma and investigator-reported adverse events.
RESULTS: Twenty-six eyes from 22 patients were included, with 96.2% having an indication including UME. During the 12-month study, the FAc implant was effective in 15 (57.7%) eyes, reaching effectiveness as soon as 2 weeks post-implantation. Mean best-corrected visual acuity and mean central macular thickness (CMT) were significantly improved vs. baseline at all timepoints (all comparisons p < 0.01). During the 12-month study, inflammation markers (anterior chamber cells and vitreous haze) had also significantly declined. Factors predicting effectiveness at month 12 were systemic corticosteroid dose pre-FAc, higher immunomodulatory therapy (IMT) load at baseline and thicker retinal nerve fibre layer (RNFL) at baseline (all p < 0.05). Factors predicting failure were male gender, thinner RNFL at baseline and treatment ineffectiveness at 1 month (all p < 0.05). In parallel, corticosteroid and IMT use also declined significantly. No significant increase in IOP was detected.
CONCLUSIONS: The FAc implant is safe and effective at treating NIU over 12 months in a real-world setting in Spain.
METHODS: A prospective study of patients who had NIU including uveitic macular oedema (UME) with ≥ 12 months follow-up was done. Exclusion criteria include infectious uveitis and uncontrolled glaucoma or ocular hypertension requiring more than 2 medications. Effectiveness was assessed using a multicomponent outcome measure that included nine outcomes. Effectiveness was defined as all components being met at every timepoint. Secondary outcome measures were onset or progression of glaucoma and investigator-reported adverse events.
RESULTS: Twenty-six eyes from 22 patients were included, with 96.2% having an indication including UME. During the 12-month study, the FAc implant was effective in 15 (57.7%) eyes, reaching effectiveness as soon as 2 weeks post-implantation. Mean best-corrected visual acuity and mean central macular thickness (CMT) were significantly improved vs. baseline at all timepoints (all comparisons p < 0.01). During the 12-month study, inflammation markers (anterior chamber cells and vitreous haze) had also significantly declined. Factors predicting effectiveness at month 12 were systemic corticosteroid dose pre-FAc, higher immunomodulatory therapy (IMT) load at baseline and thicker retinal nerve fibre layer (RNFL) at baseline (all p < 0.05). Factors predicting failure were male gender, thinner RNFL at baseline and treatment ineffectiveness at 1 month (all p < 0.05). In parallel, corticosteroid and IMT use also declined significantly. No significant increase in IOP was detected.
CONCLUSIONS: The FAc implant is safe and effective at treating NIU over 12 months in a real-world setting in Spain.
摘要：
目的：本研究通过多模式测量评估了0.19mg氟轻松（FAc）植入物在西班牙非感染性葡萄膜炎（NIU）患者中的有效性。
方法：对患有NIU包括葡萄膜性黄斑水肿（UME）的患者进行了前瞻性研究，随访时间≥12个月。排除标准包括感染性葡萄膜炎和不受控制的青光眼或需要超过2种药物的高眼压。使用包括9个结果的多成分结果测量来评估有效性。有效性定义为在每个时间点满足所有组件。次要结果指标是青光眼的发作或进展以及研究者报告的不良事件。
结果：纳入22例患者的26只眼，96.2%有包括UME在内的适应症。在为期12个月的研究中，FAc植入物对15只(57.7%)眼有效，植入后2周即可达到疗效。平均最佳矫正视力和平均中央黄斑厚度（CMT）显着改善与所有时间点的基线(所有比较p<0.01)。在为期12个月的研究中，炎症标志物（前房细胞和玻璃体雾霾）也显着下降。预测12个月时疗效的因素是FAc前的全身皮质类固醇剂量，基线时免疫调节治疗（IMT）负荷较高，基线时视网膜神经纤维层（RNFL）较厚（均p<0.05）。预测失败的因素是男性，基线时RNFL较薄，1个月时治疗无效（均p<0.05）。并行,皮质类固醇和IMT的使用也显著下降.未检测到IOP的显著增加。
结论：在西班牙的现实环境中，FAc植入物在治疗NIU超过12个月时是安全有效的。
方法：对患有NIU包括葡萄膜性黄斑水肿（UME）的患者进行了前瞻性研究，随访时间≥12个月。排除标准包括感染性葡萄膜炎和不受控制的青光眼或需要超过2种药物的高眼压。使用包括9个结果的多成分结果测量来评估有效性。有效性定义为在每个时间点满足所有组件。次要结果指标是青光眼的发作或进展以及研究者报告的不良事件。
结果：纳入22例患者的26只眼，96.2%有包括UME在内的适应症。在为期12个月的研究中，FAc植入物对15只(57.7%)眼有效，植入后2周即可达到疗效。平均最佳矫正视力和平均中央黄斑厚度（CMT）显着改善与所有时间点的基线(所有比较p<0.01)。在为期12个月的研究中，炎症标志物（前房细胞和玻璃体雾霾）也显着下降。预测12个月时疗效的因素是FAc前的全身皮质类固醇剂量，基线时免疫调节治疗（IMT）负荷较高，基线时视网膜神经纤维层（RNFL）较厚（均p<0.05）。预测失败的因素是男性，基线时RNFL较薄，1个月时治疗无效（均p<0.05）。并行,皮质类固醇和IMT的使用也显著下降.未检测到IOP的显著增加。
结论：在西班牙的现实环境中，FAc植入物在治疗NIU超过12个月时是安全有效的。
