Pecen Paula E, Kaiser Peter K
Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA.
Curr Opin Ophthalmol. 2015 May;26(3):188-93. doi: 10.1097/ICU.0000000000000147.
The purpose of this review is to provide an update of phase 1 and 2 clinical trials in neovascular age-related macular degeneration that are either currently underway or recently completed by the end of 2014.
Three gene therapy options are currently in early clinical trials, administered via intravitreal (AAV2-sFLT01) or subretinal (AVA-101 and RetinoStat) injection to express angiogenesis inhibitors. Several eye drops are being developed for topical administration for various angiogenic inhibitors, including regorafenib, squalamine lactate, and PAN-90806. Early development of systemic administration options may be intravenous (iSONEP) or oral (X-82). Initial study of local radiation therapy may be via proton beam irradiation or stereotactic radiotherapy. Several intravitreal injections are being studied including human immuno-conjugate molecule (hl-con1), abicipar pegol, PF582, DE-120, ESBA 1008, and REGN2176-3.
Numerous treatment options of neovascular age-related macular degeneration are in phase 1/2 clinical trials including gene therapy, eye drops, systemic dosing, localized irradiation, and various intravitreal injections. Future phase 3 trial results will be observed closely to determine which of these therapies will be the next novel treatment of neovascular age-related macular degeneration.
本综述旨在更新2014年底前正在进行或最近完成的新生血管性年龄相关性黄斑变性的1期和2期临床试验情况。
目前有三种基因治疗方案正处于早期临床试验阶段，通过玻璃体内注射（AAV2-sFLT01）或视网膜下注射（AVA-101和RetinoStat）来表达血管生成抑制剂。正在研发几种用于局部给药的眼药水，用于多种血管生成抑制剂，包括瑞戈非尼、乳酸鲨胺和PAN-90806。全身给药方案的早期研发可能是静脉注射（iSONEP）或口服（X-82）。局部放射治疗的初步研究可能通过质子束照射或立体定向放射治疗。正在研究几种玻璃体内注射药物，包括人免疫缀合分子（hl-con1）、阿柏西普聚乙二醇、PF582、DE-120、ESBA 1008和REGN2176-3。
新生血管性年龄相关性黄斑变性的众多治疗方案正处于1/2期临床试验阶段，包括基因治疗、眼药水、全身给药、局部照射和各种玻璃体内注射。未来将密切观察3期试验结果，以确定这些疗法中哪一种将成为新生血管性年龄相关性黄斑变性的下一种新型治疗方法。
