Vardarinos Athanasios, Gupta Nitin, Janjua Raazia, Iron Abigail, Empeslidis Theo, Tsaousis Konstantinos T
Eye Treatment Centre, West Suffolk Hospital, Bury St Edmunds, UK.
Department of Ophthalmology, Leicester Royal Infirmary, University Hospitals of Leicester, Leicester, UK.
BMC Ophthalmol. 2017 Apr 27;17(1):58. doi: 10.1186/s12886-017-0451-1.
To evaluate the clinical effectiveness and analyze the outcomes of a treat-and-extend (T&E) treatment regimen with ranibizumab for wet age-related macular degeneration (ARMD) in real life clinical settings over the first 2 years (24 months) of treatment.
Retrospective analysis of visual acuity, spectral domain optical coherence tomography (SD-OCT) parameters and treatment burden data of 56 eyes of 54 unselected treatment naive patients diagnosed with exudative ARMD. Monthly injections were offered until no signs of disease activity such as intra-retinal (IRF) or sub-retinal fluid (SRF) were evident on SD-OCT, followed by a gradual extension of the treatment interval by 2 weeks until a maximum of 12 weeks.
The study met its main objective, demonstrating a mean best-corrected visual acuity gain of 8.3 letters (mean 68.8 ± 11) at month 12 and 5.2 letters (mean 65.7 ± 12.3) at 24 months compared to baseline (mean 60.5 ± 8.9). Anatomical improvement was also documented with a mean reduction of central retinal thickness by 139.7 μm at 24 months (244.9 ± 48.3) compared to baseline (384.6 ± 154.9). Forty-seven eyes (83.9% N = 56) gained vision or preserved baseline vision with 23 eyes (41.1%) gaining 10 letters or more at month 12. Out of the 46 eyes that completed 24 months of treatment and monitoring, 27 (58.7% N = 46) kept a BCVA above baseline with 18 of those (39% N = 46) maintaining a 10-letter gain throughout the 24 months. Six eyes (13% N = 46) lost more than 10 letters by month 24. The mean number of injections was 12.1 ± 2.8 over the 24-month period. Twenty-seven eyes (55.1% N = 56) achieved a treatment interval of 10 weeks or more at month 12, while the respective number at month 24 was 20 eyes (43.4% N = 46) in addition though to four more patients (8.7% N = 46) who were not receiving injections at month 24 since they were placed on a Monitor & Extend regime.
This is the first UK real-life study of a T&E treatment protocol with ranibizumab for exudative ARMD in a 24-month period and suggests that such a regimen is clinically effective and can achieve favourable outcomes with a significant reduction of the treatment burden compared to monthly PRN.
评估雷珠单抗治疗延长方案（T&E）在现实临床环境中治疗湿性年龄相关性黄斑变性（ARMD）头2年（24个月）的临床疗效并分析其结果。
回顾性分析54例初治未筛选的渗出性ARMD患者56只眼的视力、频域光学相干断层扫描（SD-OCT）参数及治疗负担数据。每月注射给药，直至SD-OCT上无疾病活动迹象，如视网膜内液（IRF）或视网膜下液（SRF），随后治疗间隔逐渐延长2周，直至最长12周。
该研究达到其主要目标，与基线（平均60.5±8.9）相比，在第12个月时平均最佳矫正视力提高8.3个字母（平均68.8±11），在24个月时提高5.2个字母（平均65.7±12.3）。还记录了解剖学改善情况，与基线（384.6±154.9）相比，24个月时中心视网膜厚度平均减少139.7μm（244.9±48.3）。47只眼（83.9%，N = 56）视力提高或维持基线视力，其中23只眼（41.1%）在第12个月时视力提高10个字母或更多。在完成24个月治疗和监测的46只眼中，27只眼（58.7%，N = 46）的最佳矫正视力保持在基线以上，其中18只眼（39%，N = 46）在整个24个月期间视力提高10个字母。到第24个月时，6只眼（13%，N = 46）视力下降超过10个字母。24个月期间平均注射次数为12.1±2.8次。27只眼（55.1%，N = 56）在第12个月时治疗间隔达到10周或更长，而在第24个月时相应数字为20只眼（43.4%，N = 46），另外还有4名患者（8.7%，N = 46）在第个月未接受注射，因为他们进入了监测与延长方案。
这是英国第一项在24个月期间使用雷珠单抗T&E治疗方案治疗渗出性ARMD的现实研究，表明该方案临床有效，与每月按需治疗相比，可显著减轻治疗负担并取得良好结果。
