Catholic University of Sacred Heart, "A. Gemelli" Foundation, Largo A. Gemelli, 00168, Rome, Italy.
BioDrugs. 2016 Aug;30(4):353-9. doi: 10.1007/s40259-016-0179-0.
The results regarding changes of choroidal thickness following intravitreal ranibizumab injections in the literature are controversial. Vascular endothelial growth factor A is implicated in pathogenesis of neovascular age-related macular degeneration (AMD). The suspected unchanged choroidal layer thickness after intravitreal injections of ranibizumab suggests a possible protection of the outer blood-retinal barrier in the human eye.
The aim was to evaluate choroidal thickness following the first administration of the study drug ranibizumab into the eyes of naïve wet AMD patients (nAMD).
In this open label, 3-month, prospective, single-center, interventional, single-arm pilot study, 20 nAMD eyes were included and underwent three consecutive monthly injections of ranibizumab (0.5 mg/0.05 ml). Vital signs (i.e., blood pressure and pulse), ophthalmic examinations, intraocular pressure, best correct visual acuity and subfoveal choroidal thickness as examined with optical coherence tomography using enhanced depth imaging (OCT-EDI) were assessed at each visit. All patients were evaluated at baseline and at 15, 30 60 and 90 days after intravitreal injection. Ten eyes with fibrotic AMD lesions were evaluated as the control group.
In all eyes, the choroidal thicknesses (µm) exhibited no significant changes from the baseline visit to the visits at 15, 30, 60 and 90 days post-injection (P > 0.05). The intravitreal treatment with ranibizumab was well tolerated, and no adverse events were registered.
Choroidal thickness appeared to be unmodified following the intravitreal injection of ranibizumab into nAMD eyes. Intravitreal ranibizumab injections probably elicit a pharmacologic effect only in the choroidal neovascularization and not in the choroid circulation under neovascular lesions. Clinical Trials Eudract Registration #: 2013-005091-17.
文献中关于玻璃体内雷珠单抗注射后脉络膜厚度变化的结果存在争议。血管内皮生长因子 A 与新生血管性年龄相关性黄斑变性（AMD）的发病机制有关。在玻璃体内注射雷珠单抗后，脉络膜层厚度疑似未发生变化，这表明人类眼睛的外血视网膜屏障可能受到了保护。
评估初次玻璃体内给予研究药物雷珠单抗治疗的初发湿性年龄相关性黄斑变性（nAMD）患者的脉络膜厚度。
在这项开放标签、3 个月、前瞻性、单中心、干预性、单臂试验研究中，纳入了 20 只 nAMD 眼，并接受了连续 3 个月的每月玻璃体内雷珠单抗（0.5mg/0.05ml）注射。每次就诊时评估生命体征（即血压和脉搏）、眼科检查、眼压、最佳矫正视力和使用增强深度成像（OCT-EDI）光学相干断层扫描检查的中心凹下脉络膜厚度。所有患者在基线和玻璃体内注射后 15、30、60 和 90 天进行评估。10 只纤维化 AMD 病变眼作为对照组进行评估。
所有眼的脉络膜厚度（µm）在基线就诊与注射后 15、30、60 和 90 天就诊时均无明显变化（P＞0.05）。玻璃体内给予雷珠单抗治疗耐受性良好，未出现不良事件。
nAMD 眼玻璃体内注射雷珠单抗后，脉络膜厚度似乎未发生改变。玻璃体内雷珠单抗注射可能仅在脉络膜新生血管中产生药理作用，而不在新生血管病变下的脉络膜循环中产生作用。临床试验 Eudract 注册号：2013-005091-17。
