Medical Retina, Singapore National Eye Centre, Singapore.
Retina Research Group, Singapore Eye Research Institute, Singapore.
Br J Ophthalmol. 2022 Jul;106(7):987-993. doi: 10.1136/bjophthalmol-2020-318354. Epub 2021 Feb 11.
To compare the efficacy of aflibercept using a personalised versus fixed regimen in treatment-naïve participants with polypoidal choroidal vasculopathy (PCV).
A 52-week, randomised, open-label, non-inferiority, single-centre study that included participants with symptomatic PCV. Participants were randomised (3:1 ratio) to receive either personalised (n=40) or fixed 8-weekly treatment regimen (n=13). The personalised regimen allowed for either early treat and extend (T&E) after week 12 or late T&E with 3 additional 4-weekly aflibercept injections until week 24 in participants with residual polypoidal lesions (PL) on indocyanine green angiography (ICGA) at week 12.
Non-inferiority of personalised to fixed regimen for mean change in best-corrected visual acuity (BCVA) from baseline to week 52 (non-inferiority margin: -5 letters). The key secondary outcomes include reduction in central subfield thickness (CSFT) on optical coherence tomography and the anatomical closure of PL on ICGA.
Of the 53 participants, the mean (SD) age was 69.2 (8.1) years, 19 (35.8 %) were male. Personalised group was non-inferior to fixed for the primary end point (+8.1 vs +7.9 letters at week 52, respectively; difference 0.16, 95% CI -2.8 to 2.4, p=0.79). There was greater reduction in mean CSFT (SD) in the personalised versus fixed group (-248.8 (169.9) vs -164.8 (148.9) µm, p=0.03). Closure of PL occurred in 21 (55.2%) and 5 (41.6%) of study eyes in personalised and fixed groups, respectively at week 52 (p=0.41).
Personalised regimen achieved non-inferior BCVA gain and numerically higher PL closure compared with fixed regimen.
NCT03117634.
比较在初治有息肉样脉络膜血管病变（PCV）的患者中，使用阿柏西普个体化方案与固定方案治疗的疗效。
这是一项为期 52 周的、随机的、开放标签的、非劣效性、单中心研究，纳入了有症状的 PCV 患者。参与者按照 3:1 的比例随机（n=40）接受个体化（n=40）或固定 8 周方案（n=13）治疗。个体化方案允许在第 12 周时，如果吲哚菁绿血管造影（ICGA）显示残留息肉样病变（PL），则早期治疗和扩展（T&E）或晚期 T&E，即再加用 3 次 4 周的阿柏西普治疗，直到第 24 周。
从基线到第 52 周时，个体化方案与固定方案治疗相比，最佳矫正视力（BCVA）的平均变化（非劣效性边界：-5 个字母）。主要次要结局包括光学相干断层扫描（OCT）上中央视网膜神经纤维层厚度（CSFT）的减少和 ICGA 上 PL 的解剖学闭合。
53 名参与者中，平均（SD）年龄为 69.2（8.1）岁，19 名（35.8%）为男性。个体化组在主要终点上非劣于固定组（第 52 周时分别为+8.1 比+7.9 个字母；差值为 0.16，95%置信区间-2.8 至 2.4，p=0.79）。个体化组 CSFT 的平均（SD）减少量大于固定组（-248.8（169.9）比-164.8（148.9）µm，p=0.03）。在第 52 周时，个体化组和固定组分别有 21 只（55.2%）和 5 只（41.6%）研究眼的 PL 闭合（p=0.41）。
与固定方案相比，个体化方案实现了非劣效的 BCVA 改善，且 PL 闭合率更高。
NCT03117634。
