Abstract：
OBJECTIVE: Persistent diabetic macular edema (DME) remains a problem in clinical practice, with many patients having a suboptimal response to the standard of care (SOC). Evidence supports the long-term efficacy of intravitreal fluocinolone acetonide (FAc) implant (ILUVIEN®) in patients that have responded sub-optimally, although there is still scarce data from real-world Portuguese practices. We aimed to monitor the current SOC in selected Portuguese practices prior to FAc implantation and then assess the long-term effectiveness and safety of the FAc implant.
METHODS: The study included patient data from five Portuguese public hospitals.
METHODS: This was a non-interventional, multicenter audit of data collected from Retina.pt registry from patients with persistent or recurrent DME despite treatment.
METHODS: Outcome measures included changes in best-corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP). Results were compared at regular times over 36 months.
RESULTS: This study included 222 eyes from 152 patients. A significant decrease in BCVA (P < 0.001) and a significant increase in CMT (P = 0.013) were observed prior to FAc. A significant increase in BCVA was registered at 6 months after FAc implant administration (P < 0.001), which was maintained during follow-up. No relevant changes in IOP were observed. Treatment burden was reduced as a result of treatment with FAc (P < 0.001 for anti-VEGF, corticosteroids, or both treatments) in the full population.
CONCLUSIONS: In Portuguese practice, data showed that pre-FAc implantation, some patients did not respond to SOC treatment and/or they were undertreated. Following FAc implant administration, there were rapid, sustained, long-term visual and anatomical improvements, and a marked reduction in treatment burden.
METHODS: The study included patient data from five Portuguese public hospitals.
METHODS: This was a non-interventional, multicenter audit of data collected from Retina.pt registry from patients with persistent or recurrent DME despite treatment.
METHODS: Outcome measures included changes in best-corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP). Results were compared at regular times over 36 months.
RESULTS: This study included 222 eyes from 152 patients. A significant decrease in BCVA (P < 0.001) and a significant increase in CMT (P = 0.013) were observed prior to FAc. A significant increase in BCVA was registered at 6 months after FAc implant administration (P < 0.001), which was maintained during follow-up. No relevant changes in IOP were observed. Treatment burden was reduced as a result of treatment with FAc (P < 0.001 for anti-VEGF, corticosteroids, or both treatments) in the full population.
CONCLUSIONS: In Portuguese practice, data showed that pre-FAc implantation, some patients did not respond to SOC treatment and/or they were undertreated. Following FAc implant administration, there were rapid, sustained, long-term visual and anatomical improvements, and a marked reduction in treatment burden.
摘要：
目的：糖尿病性黄斑水肿（DME）在临床实践中仍然存在问题，许多患者对护理标准（SOC）的反应欠佳。有证据支持玻璃体内注射氟轻松（FAc）植入物（ILUNEN®）对反应欠佳的患者的长期疗效，尽管来自现实世界葡萄牙实践的数据仍然很少。我们旨在在FAc植入前监测选定的葡萄牙实践中的当前SOC，然后评估FAc植入的长期有效性和安全性。
方法：该研究包括来自五家葡萄牙公立医院的患者数据。
方法：这是非干预性的，对从Retina收集的数据进行多中心审计。尽管接受了治疗，但仍有持续性或复发性DME患者的pt登记。
方法：结果测量包括最佳矫正视力（BCVA）的变化，黄斑中心厚度(CMT),和眼内压（IOP）。在36个月内定期比较结果。
结果：本研究包括152名患者的222只眼。在FAc之前观察到BCVA的显着降低（P<0.001）和CMT的显着增加（P=0.013）。FAc植入物给药后6个月，BCVA显着增加（P<0.001），在随访期间保持不变。未观察到IOP的相关变化。由于用FAc治疗，治疗负担降低（抗VEGF的P<0.001，皮质类固醇,或两种治疗)在全部人群中。
结论：在葡萄牙语实践中，数据显示，前FAc植入，一些患者对SOC治疗无反应和/或治疗不足.FAc植入后，很快，持续,长期的视觉和解剖学改善，治疗负担明显减轻。
方法：该研究包括来自五家葡萄牙公立医院的患者数据。
方法：这是非干预性的，对从Retina收集的数据进行多中心审计。尽管接受了治疗，但仍有持续性或复发性DME患者的pt登记。
方法：结果测量包括最佳矫正视力（BCVA）的变化，黄斑中心厚度(CMT),和眼内压（IOP）。在36个月内定期比较结果。
结果：本研究包括152名患者的222只眼。在FAc之前观察到BCVA的显着降低（P<0.001）和CMT的显着增加（P=0.013）。FAc植入物给药后6个月，BCVA显着增加（P<0.001），在随访期间保持不变。未观察到IOP的相关变化。由于用FAc治疗，治疗负担降低（抗VEGF的P<0.001，皮质类固醇,或两种治疗)在全部人群中。
结论：在葡萄牙语实践中，数据显示，前FAc植入，一些患者对SOC治疗无反应和/或治疗不足.FAc植入后，很快，持续,长期的视觉和解剖学改善，治疗负担明显减轻。
