Tiosano L, Segal O, Mathalone N, Pollack A, Ehrlich R, Klemperer I, Barak Y, Moroz I, Chowers I, Goldstein M
Department of Ophthalmology Hadassah, Hebrew University Medical Center, Jerusalem, Israel.
Meir Medical Center, Kfar Sava, affiliated to the Sackler School of Medicine, Tel Aviv University, Israel.
Eye (Lond). 2017 Jun;31(6):890-898. doi: 10.1038/eye.2017.7. Epub 2017 Feb 17.
PurposeThe purpose of this study is to evaluate an early switch to aflibecept in eyes with neovascular age-related macular degeneration (nvAMD) showing partial or lack of response for initial therapy with bevacizumab.MethodsThe Aflibercept as a Second Line Therapy for Neovascular Age Related Macular Degeneration in Israel (ASLI) was a prospective, multicenter, single-arm clinical trial. Eyes with nvAMD having incomplete response to 3-9 prior bevacizumab injections were recruited. Three monthly intravitreal aflibercept (2 mg) injections were administered, followed by two bi-monthly injections and a final examination at week 28. An optional injection was allowed at week 20.ResultsForty-seven eyes of 46 patients (mean±SD age 76±8 years) were recruited. The mean number of prior bevacizumab injections was 5.5±2.9. The mean visual acuity improved from 60.3±10 ETDRS letters at baseline to 63.1±15 letters at week 28 (P=0.02, paired t-test). The central subfield thickness (CST) reduced from 409±127 micron at baseline to 330±110 microns at week 4 (P=0.0002; paired t-test), and 277±70 microns at week 28 (P=0.00002; paired t-test). Twenty-two eyes had three to five prior bevacizumab injections (mean 5.1±0.7), and 25 eyes had six to nine prior injections (7.32±1.2). Both groups had reduced CST from baseline to week 28 (P=0.0004 and P=0.0007; paired t-test, respectively). Thirty-five (75%) eyes required the optional additional aflibercept injection at week 20.ConclusionsThe ASLI study demonstrated improved BCVA and reduced CST following an early switch to aflibercept therapy in eyes with prior incomplete response to initial therapy with three to nine bevacizumab injections.
目的
本研究的目的是评估在新生血管性年龄相关性黄斑变性（nvAMD）眼中早期转换为阿柏西普的疗效，这些眼睛对贝伐单抗初始治疗显示部分反应或无反应。
方法
以色列阿柏西普作为新生血管性年龄相关性黄斑变性的二线治疗（ASLI）是一项前瞻性、多中心、单臂临床试验。招募了对之前3 - 9次贝伐单抗注射反应不完全的nvAMD患者。每月进行3次玻璃体内注射阿柏西普（2mg），随后每两个月注射一次，并在第28周进行最后一次检查。允许在第20周进行一次可选注射。
结果
招募了46例患者的47只眼（平均±标准差年龄76±8岁）。之前贝伐单抗注射的平均次数为5.5±2.9次。平均视力从基线时的60.3±10 ETDRS字母提高到第28周时的63.1±15字母（P = 0.02，配对t检验）。中心子场厚度（CST）从基线时的409±127微米降至第4周时的330±110微米（P = 0.0002；配对t检验），以及第28周时的277±70微米（P = 0.00002；配对t检验）。22只眼之前接受了3 - 5次贝伐单抗注射（平均5.1±0.7次），25只眼之前接受了6 - 9次注射（7.32±1.2次）。两组从基线到第28周CST均降低（分别为P = 0.0004和P = 0.0007；配对t检验）。35只（75%）眼在第20周需要进行可选的额外阿柏西普注射。
结论
ASLI研究表明，在之前对3 - 9次贝伐单抗初始治疗反应不完全的眼中，早期转换为阿柏西普治疗后，最佳矫正视力（BCVA）得到改善，CST降低。
