Ruys Joke, Mangelschots Els, Jacob Julie, Mergaerts Filip, Kozyreff Alexandra, Dirven Werner
Department of Ophthalmology, ZNA Middelheim, Antwerp, Belgium.
Oogartsenpraktijk Alken, Alken, Belgium.
Ophthalmol Ther. 2020 Dec;9(4):993-1002. doi: 10.1007/s40123-020-00300-7. Epub 2020 Sep 18.
STELLAR was a Belgian, multicentre, retrospective, observational chart review that described the utilization (number of injections and treatment regimen) and effectiveness of intravitreal aflibercept (IVT-AFL) in patients with anti-vascular endothelial growth factor (VEGF) treatment-naïve neovascular age-related macular degeneration (nAMD) during the first 12 months of IVT-AFL treatment.
Patients initiating IVT-AFL between July 2013 and July 2017 were included in STELLAR. Primary endpoints were number of visits and IVT-AFL injections, and number of patients who received ≥ 7 versus < 7 IVT-AFL injections during the first 12 months of treatment.
A total of 337 patients completed ≥ 12 months of IVT-AFL treatment. The mean number of visits and mean number of injections during the first 12 months was 9.8 and 7.1 injections, respectively (64% received ≥ 7 injections). Overall, 96% of patients received ≥ 3 initial monthly injections. Of the 337 patients, 180 received VT-AFL as needed (pro re nata), 141 received it as treat-and-extend dosing and 16 received it as fixed dosing. The proportion of patients who received treat-and-extend dosing increased year-on-year. Mean best-corrected visual acuity (BCVA) (± standard deviation) was 61.6 (± 14.9) Early Treatment Diabetic Retinopathy Study (ETDRS) letters at baseline and improved by + 3.9 and + 5.7 ETDRS letters at 3 and 12 months, respectively. Mean BCVA improvement was numerically greater in patients who received ≥ 7 versus < 7 injections during the first 12 months 7 (+ 6.5 vs. + 4.4 ETDRS letters) and in patients who received ≥ 3 versus < 3 initial monthly injections (+ 5.2 vs. - 0.25 ETDRS letters [3 at months]; + 5.9 vs + 1.2 ETDRS letters [at 12 months]). No specific adverse events were reported.
Most patients in this Belgian study received ≥ 7 IVT-AFL injections during a mean of 9.8 visits over the 12 months assessed. IVT-AFL was an effective treatment for nAMD in clinical practice, with numerically higher BCVA gains in patients receiving ≥ 7 versus < 7 injections over the first 12 months and ≥ 3 versus < 3 injections in the first 3 months.
STELLAR是一项比利时多中心回顾性观察性图表审查研究,描述了在抗血管内皮生长因子(VEGF)初治的新生血管性年龄相关性黄斑变性(nAMD)患者中,玻璃体内注射阿柏西普(IVT-AFL)治疗头12个月的使用情况(注射次数和治疗方案)及疗效。
2013年7月至2017年7月开始接受IVT-AFL治疗的患者被纳入STELLAR研究。主要终点为就诊次数、IVT-AFL注射次数,以及在治疗头12个月接受≥7次与<7次IVT-AFL注射的患者数量。
共有337例患者完成了≥12个月的IVT-AFL治疗。治疗头12个月的平均就诊次数和平均注射次数分别为9.8次和7.1次(64%的患者接受了≥7次注射)。总体而言,96%的患者接受了≥3次初始每月注射。在337例患者中,180例按需接受IVT-AFL治疗(根据病情),141例接受治疗并延长给药方案,16例接受固定给药方案。接受治疗并延长给药方案的患者比例逐年增加。平均最佳矫正视力(BCVA)(±标准差)在基线时为61.6(±14.9)早期糖尿病性视网膜病变研究(ETDRS)视力表字母,在3个月和12个月时分别提高了+3.9和+5.7个ETDRS视力表字母。在治疗头12个月接受≥7次与<7次注射的患者(+6.5 vs. +4.4个ETDRS视力表字母)以及接受≥3次与<3次初始每月注射的患者中(3个月时为+5.2 vs. -0.25个ETDRS视力表字母;12个月时为+5.9 vs +1.2个ETDRS视力表字母),平均BCVA改善在数值上更大。未报告特定不良事件。
在这项比利时研究中,大多数患者在评估的12个月内平均9.8次就诊期间接受了≥7次IVT-AFL注射。在临床实践中,IVT-AFL是治疗nAMD的有效方法,在治疗头12个月接受≥7次与<7次注射以及头3个月接受≥3次与<3次注射的患者中,BCVA改善在数值上更高。