Hatz Katja, Prünte Christian
Vista Klinik, Binningen, Switzerland.
Department of Ophthalmology, Kantonsspital Liestal, Switzerland.
Acta Ophthalmol. 2017 Feb;95(1):e67-e72. doi: 10.1111/aos.13031. Epub 2016 Mar 24.
To compare outcomes in patients with treatment-naïve neovascular age-related macular degeneration (nAMD) receiving ranibizumab treat and extend (TE) with those receiving ranibizumab pro re nata (PRN) in a clinical setting.
During this 12-month retrospective, consecutive, comparative case series, patients received ranibizumab 0.5 mg according to a TE or PRN regimen. Monthly optical coherence tomography (OCT) evaluation was performed during the PRN regimen; retreatment criteria included recurrence of intra-/subretinal fluid, or haemorrhages. During the TE regimen, initial treatment with 4-week intervals was sequentially lengthened by 2 weeks until signs of choroidal neovascularization (CNV) activity recurred. Study end-points included mean change in best corrected visual acuity (BCVA) and central retinal thickness (CRT), mean injection frequency and number of follow-up visits attended.
Baseline characteristics were similar between the TE (n = 70) and PRN (n = 70) groups. Mean change in BCVA from baseline to Month 12 was significantly greater in the TE group than the PRN group (+0.18 ± 0.17 versus +0.07 ± 0.20, p < 0.001). Mean change in CRT from baseline to Month 12 was greater in the TE group than the PRN group (-116 ± 132 versus -58 ± 157 μm, p = 0.019). The number of follow-up visits attended was significantly higher in the PRN group than the TE group (11.9 ± 1.1 versus 8.6 ± 1.9, p < 0.001), while patients in the TE group received more injections during the study than those in the PRN group (8.6 ± 1.9 versus 6.0 ± 1.9, p < 0.001).
Ranibizumab administered using a TE regimen in treatment-naïve patients with nAMD provided better visual outcomes with fewer clinic visits, compared with a PRN regimen.
在临床环境中比较初治新生血管性年龄相关性黄斑变性(nAMD)患者接受雷珠单抗治疗并延长给药方案(TE)与接受雷珠单抗按需给药方案(PRN)的治疗效果。
在这个为期12个月的回顾性、连续、比较性病例系列研究中,患者根据TE或PRN方案接受0.5毫克雷珠单抗治疗。在PRN方案期间每月进行光学相干断层扫描(OCT)评估;再次治疗标准包括视网膜内/视网膜下液或出血复发。在TE方案期间,最初每4周一次的治疗间隔依次延长2周,直到脉络膜新生血管(CNV)活动迹象再次出现。研究终点包括最佳矫正视力(BCVA)和中心视网膜厚度(CRT)的平均变化、平均注射频率和随访就诊次数。
TE组(n = 70)和PRN组(n = 70)的基线特征相似。从基线到第12个月,TE组的BCVA平均变化显著大于PRN组(+0.18±0.17对+0.07±0.20,p < 0.001)。从基线到第12个月,TE组的CRT平均变化大于PRN组(-116±132对-58±157μm,p = 0.019)。PRN组的随访就诊次数显著高于TE组(11.9±1.1对8.6±l.9,p < 0.001),而TE组患者在研究期间接受的注射比PRN组更多(8.6±1.9对6.0±1.9,p < 0.001)。
与PRN方案相比,在初治nAMD患者中使用TE方案给予雷珠单抗可提供更好的视力结果,且就诊次数更少。