Parvin Parmis, Zola Marta, Dirani Ali, Ambresin Aude, Mantel Irmela
Department of Ophthalmology, University of Lausanne, Jules Gonin Eye Hospital, Fondation Asile des Aveugles, Lausanne, Switzerland.
Graefes Arch Clin Exp Ophthalmol. 2017 Nov;255(11):2127-2134. doi: 10.1007/s00417-017-3762-2. Epub 2017 Aug 10.
The purpose of our study was to investigate the two-year outcome of Aflibercept treatment for neovascular age-related macular degeneration (nAMD), using the Observe-and-Plan regimen, an individually planned treatment regimen, based on the predictability of an individual's need for retreatment, aiming to reduce the clinical burden.
Our prospective study used the Observe-and-Plan regimen with Aflibercept to treat nAMD: Three loading doses, followed by monthly observation visits until the disease-recurrence interval was determined, which then was shortened by 2 weeks in a treatment plan for the next three injections without intermediate monitoring visits. The subsequent treatment plans were adjusted according to periodically assessed disease activity. The primary outcome measures were visual acuity changes, number of injections, and number of monitoring visits.
The study included 112 eyes of 102 patients with a mean age of 80.7 years (SD 7.6). Mean visual acuity (VA) improved from 61.8 ETDRS letters (20/60) at baseline, by 8.5, 8.0, and 6.2 letters at months 3, 12 and 24, respectively. Mean central retinal thickness was 438um at baseline, and reduced by 152um, 155um, and 150um at months 3, 12 and 24, respectively. The mean number of injections was 8.7 and 6.5 in the first and second year, respectively. The mean number of monitoring visits after baseline was 3.8 and 2.8 during the first and second year, respectively.
The Observe-and-Plan regimen significantly improved VA, while fewer monitoring visits were needed as compared to other variable dosing regimens, thus reducing the workload for chronic care management of nAMD.
本研究旨在使用“观察与计划”方案（一种基于个体再次治疗需求的可预测性进行个体化规划的治疗方案），调查阿柏西普治疗新生血管性年龄相关性黄斑变性（nAMD）的两年疗效，旨在减轻临床负担。
我们的前瞻性研究采用阿柏西普“观察与计划”方案治疗nAMD：给予三次负荷剂量，随后每月进行观察访视，直至确定疾病复发间隔，然后在接下来三次注射的治疗计划中将复发间隔缩短2周，期间无需进行中间监测访视。后续治疗计划根据定期评估的疾病活动情况进行调整。主要结局指标为视力变化、注射次数和监测访视次数。
该研究纳入了102例患者的112只眼，平均年龄为80.7岁（标准差7.6）。平均视力（VA）从基线时的61.8个ETDRS字母（20/60）分别在第3、12和24个月提高了8.5、8.0和6.2个字母。平均中心视网膜厚度在基线时为438μm，在第3、12和24个月分别减少了152μm、155μm和150μm。第一年和第二年的平均注射次数分别为8.7次和6.5次。基线后的平均监测访视次数在第一年和第二年分别为3.8次和2.8次。
“观察与计划”方案显著改善了视力，与其他可变给药方案相比，所需的监测访视次数更少，从而减少了nAMD慢性护理管理的工作量。
