Göpfert Jens C, Reiser Astrid, Carcamo Yañez Viviana A, Pohle Annelie, Wessels Uwe, Heine Anne, Joos Thomas O, Petit-Frère Corinne, Nogoceke Everson, Stubenrauch Kay-Gunnar
Natural & Medical Sciences Institute, Biochemistry Department, Markwiesenstrasse 55, 72770 Reutlingen, Germany.
Roche Pharma Research & Early Development, Large Molecule Bioanalytical Sciences, Roche Innovation Center Munich, Im Nonnenwald, 82377 Penzberg, Germany.
Bioanalysis. 2019 May;11(9):875-886. doi: 10.4155/bio-2019-0044. Epub 2019 May 9.
Novel bifunctional VEGF-A neutralizing therapies are being developed for the treatment of retinal vascular diseases such as age-related macular degeneration and diabetic retinopathy. In developing new therapeutic drugs, only small aqueous humor sample volumes are available for analyzing several parameters. Highly sensitive detection methods must be applied in analyzing VEGF-A levels in ocular fluids in order to demonstrate VEGF-A suppression following drug administration. A highly sensitive immunoassay for VEGF-A was developed on the single molecule array (Simoa) platform, and validated before being used for the analysis of clinical aqueous humor samples from patients treated with anti-VEGF-A therapeutics. This highly sensitive immunoassay allows the detection of baseline VEGF-A levels and suppression effects after drug administration, even in sample volumes as low as 12 μl. The Simoa VEGF-A assay is a valuable tool for the reliable monitoring of VEGF-A suppression after intravitreal administration of anti-VEGF-A drugs.
新型双功能血管内皮生长因子A（VEGF-A）中和疗法正在研发中，用于治疗视网膜血管疾病，如年龄相关性黄斑变性和糖尿病性视网膜病变。在开发新的治疗药物时，仅有少量房水样本可用于分析多个参数。为了证明给药后VEGF-A受到抑制，必须应用高灵敏度检测方法来分析眼内液中的VEGF-A水平。在单分子阵列（Simoa）平台上开发了一种用于VEGF-A的高灵敏度免疫测定法，并在用于分析接受抗VEGF-A治疗的患者的临床房水样本之前进行了验证。这种高灵敏度免疫测定法即使在低至12微升的样本量中也能检测到基线VEGF-A水平和给药后的抑制效果。Simoa VEGF-A测定法是可靠监测玻璃体内注射抗VEGF-A药物后VEGF-A抑制情况的宝贵工具。
