Fauser Sascha, Muether Philipp S
Department of Ophthalmology, University Hospital of Cologne, Cologne, Germany.
Br J Ophthalmol. 2016 Nov;100(11):1494-1498. doi: 10.1136/bjophthalmol-2015-308264. Epub 2016 Feb 17.
To determine clinical correlations to intraocular vascular endothelial growth factor A (VEGF-A) suppression times (VSTs) on the treatment of neovascular age-related macular degeneration (nAMD) with ranibizumab (Lucentis) or aflibercept (Eylea).
Seven of 89 treatment-naïve nAMD eyes showed persistent choroidal neovascular membrane (CNV) activity throughout a spectral domain optical coherence tomography (SD-OCT)-driven pro re nata (PRN) regimen of intravitreal ranibizumab injections over 28±4 months. The treatment was switched to PRN aflibercept injections and patients were followed for another 15±2 months. A total of 160 aqueous humour specimens were collected before the intravitreal injections, and their VEGF-A concentrations were assayed by Luminex multiplex bead analysis (Luminex, Austin, Texas, USA). Intraocular VEGF-A concentrations were correlated to CNV activity shown by SD-OCT.
The mean duration of suppression of VEGF-A concentrations in aqueous humour below the lower limit of quantification of our assay was 34±5 (26-69) days for ranibizumab and 67±14 (49-89) days for aflibercept (p<0.001). The percentual reduction of central retinal volume (CRV) 6 weeks after injection was higher for aflibercept compared with ranibizumab (p=0.009). The time point of clinical re-activity occurred about 50% earlier than the respective VST for each ranibizumab and aflibercept.
The VST under aflibercept treatment exceeded that under ranibizumab treatment by a factor of 2. This difference correlated with differential clinical CRV reduction 6 weeks after the respective injection. For both medications, clinical activity was found at a time point as early as 50% of the individual VST.
NCT01213667, post-results.
确定在使用雷珠单抗(Lucentis)或阿柏西普(Eylea)治疗新生血管性年龄相关性黄斑变性(nAMD)时,眼内血管内皮生长因子A(VEGF-A)抑制时间(VSTs)的临床相关性。
在89只初治的nAMD眼中,有7只在28±4个月的基于频域光学相干断层扫描(SD-OCT)的玻璃体内雷珠单抗按需(PRN)注射方案中,脉络膜新生血管膜(CNV)持续活跃。治疗改为PRN阿柏西普注射,患者再随访15±2个月。在玻璃体内注射前共收集160份房水样本,通过Luminex多重微珠分析(Luminex,美国得克萨斯州奥斯汀)测定其VEGF-A浓度。眼内VEGF-A浓度与SD-OCT显示的CNV活性相关。
玻璃体内注射后,房水中VEGF-A浓度抑制至低于我们检测定量下限的平均持续时间,雷珠单抗为34±5(26 - 69)天,阿柏西普为67±14(49 - 89)天(p<0.001)。注射后6周,阿柏西普使中心视网膜体积(CRV)的减少百分比高于雷珠单抗(p = 0.009)。临床再激活时间点比每种药物各自的VST早约50%。
阿柏西普治疗下的VST比雷珠单抗治疗下的VST长2倍。这种差异与各自注射后6周时不同的临床CRV减少相关。对于两种药物,临床活性在早至个体VST 50%的时间点就已出现。
NCT01213667,结果公布后。