Sevik Mehmet Orkun, Tiras Nimet Zeynep, Aykut Aslan, Yigit Didem Dizdar, Sahin Ozlem
Department of Ophthalmology, Marmara University Faculty of Medicine, Istanbul, Turkiye.
North Clin Istanb. 2024 Oct 3;11(5):451-459. doi: 10.14744/nci.2024.75688. eCollection 2024.
To compare one-year anatomical and functional results of switching to an on-label intravitreal anti-vascular endothelial growth factor (anti-VEGF) agent (intravitreal ranibizumab [IVR] or aflibercept [IVA]) after treatment failure with three loading doses of off-label intravitreal bevacizumab (IVB), which is mandatory in the treatment of neovascular age-related macular degeneration (nAMD) to get reimbursement from Social Security Institution in Turkiye.
This comparative, real-life, retrospective cohort study included treatment-naïve nAMD patients treated starting with three loading doses of IVB, switched to three loading doses of IVR and IVA due to treatment failure after IVB loading, and followed up one year with a treat-and-extend (T&E) protocol with 2-week extension/shortening intervals. The primary outcomes were changes in best-corrected visual acuity (BCVA; logMAR) and central macular thickness (CMT, µm) one year after the switch, and the secondary outcomes were maximum treatment intervals, number of injections, and disease activity rates.
The mean age (72.9±8.2 and 72.2±6.7, p=0.677) and gender (60.0% and 47.4% females, p=0.398) were similar among the IVR (35 eyes/patients) and IVA (38 eyes/patients) groups. The median BCVA and CMT were significantly improved during the study period (p<0.001) with no significant intergroup differences. The ratio of 4-, 6-, 8-, 10-, and 12-week maximum treatment intervals were 28.6%, 17.1%, 14.3%, 8.6%, and 31.4% in the IVR, and 13.2%, 15.8%, 21.1%, 15.8%, and 34.2% in the IVA group (p=0.492). The median (IQR) number of injections in the IVA group (8 [7-9]) was significantly lower than the IVR group (9 [8-12]) during the one-year T&E period (p=0.026). The disease activity rates were 34.3% and 26.4% one month (p=0.610) and 37.1% and 21.1% one year (p=0.195) after the switch in IVR and IVA groups.
This real-life comparison study indicates that, after the treatment failure with three loading doses of IVB, switching to either on-label anti-VEGF agent can be regarded as comparable considering functional and anatomical results. However, although maximum treatment intervals were not significantly different, fewer injections were required with aflibercept during the one-year T&E follow-up period.
比较在使用三剂超说明书玻璃体内注射贝伐单抗（IVB）治疗失败后，改用标签内玻璃体内抗血管内皮生长因子（抗VEGF）药物（玻璃体内注射雷珠单抗[IVR]或阿柏西普[IVA]）的一年期解剖学和功能结果。在土耳其，对于新生血管性年龄相关性黄斑变性（nAMD）的治疗，使用三剂超说明书IVB是获得社会保障机构报销的必要条件。
这项比较性、真实生活、回顾性队列研究纳入了初治nAMD患者，这些患者从三剂IVB负荷剂量开始治疗，因IVB负荷治疗失败而改用三剂IVR和IVA，并采用治疗并延长（T&E）方案进行为期一年的随访，延长/缩短间隔为2周。主要结局指标为转换治疗一年后的最佳矫正视力（BCVA；logMAR）和中心黄斑厚度（CMT，μm）变化，次要结局指标为最大治疗间隔、注射次数和疾病活动率。
IVR组（35眼/患者）和IVA组（38眼/患者）的平均年龄（分别为72.9±8.2和72.2±6.7，p=0.677）和性别（女性分别为60.0%和47.4%，p=0.398）相似。在研究期间，两组的BCVA中位数和CMT均有显著改善（p<0.001），但组间无显著差异。IVR组4周、6周、8周、10周和12周最大治疗间隔的比例分别为28.6%、17.1%、14.3%、8.6%和31.4%，IVA组分别为13.2%、15.8%、21.1%、15.8%和34.2%（p=0.492）。在为期一年的T&E随访期内，IVA组的注射次数中位数（IQR）（8[7-9]）显著低于IVR组（9[8-12]）（p=0.026）。IVR组和IVA组转换治疗后1个月的疾病活动率分别为34.3%和26.4%（p=0.610），1年时分别为37.1%和21.1%（p=0.195）。
这项真实生活比较研究表明，在使用三剂IVB治疗失败后，从功能和解剖学结果来看，改用任何一种标签内抗VEGF药物均可视为具有可比性。然而，尽管最大治疗间隔无显著差异，但在为期一年的T&E随访期内，阿柏西普所需的注射次数较少。
