Ehlken Christoph, Helms Mandy, Böhringer Daniel, Agostini Hansjürgen T, Stahl Andreas
Ophthalmology, Eye Center, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg im Breisgau.
Ophthalmology, Eye Center, University Hospital Schleswig-Holstein, Campus Kiel, Germany.
Clin Ophthalmol. 2017 Dec 20;12:13-20. doi: 10.2147/OPTH.S151611. eCollection 2018.
Real-life clinical outcomes of patients treated with anti-VEGF drugs for neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), or macular edema secondary to branch retinal vein occlusion (BRVO) are often inferior to results from randomized clinical trials. This observational cohort study investigates treatment adherence and real-life clinical outcomes within the first year of treatment.
A total of 708 treatment-naïve patients (466 nAMD, 134 DME, and 108 BRVO) were included. Patients were followed with a PRN treatment protocol with three intravitreal injections (IVIs) and a series of 3 monthly injections in case of persistent or recurrent disease activity, as determined by monthly follow-up exams including optical coherence tomographies. Occurrence of gaps of >56 days between treatments or follow-up (nonadherence [NA]) and the reasons for NA (patient- or center-associated) as well as disease activity within the first 12 months of treatment were analyzed. Visual acuity (VA) as well as numbers and dates of optical coherence tomography and IVI were extracted from medical records.
NA occurred significantly more often in patients with DME (44%) than nAMD (32%) or BRVO (25%, <0.01 between groups). NA was mainly patient-associated (nAMD: 80.0%, DME: 83.1%, BRVO: 70.4%, =0.38 between groups). Patients with nAMD and DME and appropriate treatment/follow-up adherence had a better chance of significantly gaining or maintaining VA, respectively (19.9% vs 12.0% with 3-line-gain in nAMD and 1.3% vs 15.3% 3-line loss in DME; each <0.05). NA did not correlate with VA outcomes in BRVO (3-line gain 30.9% vs 48.1% and 3-line loss 8.6% vs 7.4%; >0.05).
NA to treatment and follow-up regimens is a common problem in the management of patients with AMD and DME and limits clinical treatment outcomes under real-life conditions. Patients with DME have the highest risk of patient-associated NA, associated with a higher risk for significant VA loss.
抗血管内皮生长因子(VEGF)药物治疗新生血管性年龄相关性黄斑变性(nAMD)、糖尿病性黄斑水肿(DME)或视网膜分支静脉阻塞(BRVO)继发黄斑水肿患者的实际临床疗效通常低于随机临床试验结果。这项观察性队列研究调查了治疗依从性及治疗第一年的实际临床疗效。
共纳入708例初治患者(466例nAMD、134例DME和108例BRVO)。按照按需治疗方案对患者进行随访,进行3次玻璃体内注射(IVI),若根据包括光学相干断层扫描在内的每月随访检查确定疾病持续或复发活动,则进行一系列每月1次的注射。分析治疗或随访间隔>56天(不依从[NA])的发生情况、NA的原因(患者相关或中心相关)以及治疗前12个月内的疾病活动情况。从病历中提取视力(VA)以及光学相干断层扫描和IVI的次数及日期。
DME患者中NA的发生频率(44%)显著高于nAMD患者(32%)或BRVO患者(25%,组间<0.01)。NA主要与患者相关(nAMD:80.0%,DME:83.1%,BRVO:70.4%,组间=0.38)。nAMD和DME患者且治疗/随访依从性良好者分别有更好的机会显著提高或维持VA(nAMD中视力提高3行的比例为19.9%对12.0%,DME中视力下降3行的比例为1.3%对15.3%;均<0.05)。NA与BRVO患者的VA结果无关(视力提高3行的比例为30.9%对48.1%,视力下降3行的比例为8.6%对7.4%;>0.05)。
治疗和随访方案的NA是AMD和DME患者管理中的常见问题,限制了实际临床治疗效果。DME患者患者相关NA的风险最高,与显著视力丧失的较高风险相关联