Parravano Mariacristina, Viola Francesco, Nicolò Massimo, Vujosevic Stela, Bianchino Laura, Sicari Emilia, Villa Giulia, Lanzetta Paolo
IRCCS-Fondazione Bietti, Rome, Italy.
Ophthalmology Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy.
Eur J Ophthalmol. 2025 Jul;35(4):1366-1375. doi: 10.1177/11206721241310628. Epub 2025 Feb 3.
PurposeAge-related macular degeneration (AMD) is a leading cause of irreversible vision loss, particularly neovascular AMD (nAMD). This study aimed to investigate the real-world treatment patterns, effectiveness, and safety of intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapies for anti-VEGF naïve nAMD patients in Italy.MethodsRADIANCE is a retrospective, observational, multicenter cohort study conducted at 13 clinical sites across Italy. The study enrolled all consecutive patients with nAMD, naïve to any intraocular anti-VEGF treatment and who initiated therapy with aflibercept, ranibizumab, or bevacizumab between January 2017 and November 2018. The primary objective of this study was to evaluate changes in visual acuity (VA) 52 weeks after initiating treatment with anti-VEGF.ResultsA total of 405 patients were enrolled; of these, 263 patients had at least two VA measurements and were included in the completer analysis (CA) set. At 52 weeks, the median VA change from baseline in the CA set was +1 letter, with 41.1% showing ≥ 5-letter improvement. Stratified by anti-VEGF agent, no statistically significant differences were observed. Overall, patients received a median of 5.0 (25th-75th percentile 3-6) injections of the initial anti-VEGF agent during the first year. Patients receiving ≥ 6 injections in the first year showed better VA outcomes. Undertreatment was evident at decreasing injection frequency over time.ConclusionThe results of the RADIANCE study suggest an overall moderate effectiveness after 1 year of treatment with anti-VEGF in naïve patients with nAMD in Italy. Real-world outcomes demonstrated suboptimal treatment with no significant differences among anti-VEGF agents.
目的年龄相关性黄斑变性（AMD）是不可逆视力丧失的主要原因，尤其是新生血管性AMD（nAMD）。本研究旨在调查意大利初治nAMD患者玻璃体内抗血管内皮生长因子（抗VEGF）治疗的真实世界治疗模式、有效性和安全性。方法RADIANCE是一项在意大利13个临床中心进行的回顾性、观察性、多中心队列研究。该研究纳入了所有连续性nAMD患者，这些患者未接受过任何眼内抗VEGF治疗，并于2017年1月至2018年11月期间开始使用阿柏西普、雷珠单抗或贝伐单抗治疗。本研究的主要目的是评估抗VEGF治疗开始后52周时视力（VA）的变化。结果共纳入405例患者；其中，263例患者至少有两次VA测量值，并被纳入完整分析（CA）集。在52周时，CA组中VA较基线的中位数变化为提高1行，41.1%的患者视力提高≥5行。按抗VEGF药物分层，未观察到统计学上的显著差异。总体而言，患者在第一年接受初始抗VEGF药物注射的中位数为5.0次（第25-75百分位数为3-6次）。第一年接受≥6次注射的患者视力结果更好。随着时间的推移，注射频率降低，治疗不足明显。结论RADIANCE研究结果表明，在意大利初治nAMD患者中，抗VEGF治疗1年后总体有效性中等。真实世界的结果显示治疗效果欠佳，抗VEGF药物之间无显著差异。
