Bremond-Gignac Dominique
a Ophthalmology Department , University Hospital Necker-Enfants Malades , Paris , France.
b CNRS FR3636 , Paris V René Descartes University , Paris , France.
Expert Opin Investig Drugs. 2016 Jul;25(7):841-50. doi: 10.1080/13543784.2016.1181750. Epub 2016 May 9.
Retinal vein occlusion (RVO) is the second most common retinal vascular disorder. This multifactorial disease frequently leads to visual impairment. Some risk factors for RVO can be managed prophylactically. Given the complex physiopathology of RVO, most of the latest therapeutic strategies focus on secondary clinical features (such as macular oedema and neovascularization).
This author reviews ongoing, prospective, open-label Phase I and Phase II clinical trials of novels treatments for RVO (primarily intravitreal steroids and anti-VEGF agents). Specifically, they review the pharmacokinetics, safety profile, study design and adverse events associated with innovative drugs in clinical development.
A number of innovative, early-phase clinical trials are based on combination therapy with an anti-VEGF agent and steroids. There is good evidence that early treatment of RVO has clinical benefits. Larger, randomized studies are now required for a better understanding of patient selection, treatment timing and dosing, and thus the optimized use of novel drugs and medical devices.
视网膜静脉阻塞（RVO）是第二常见的视网膜血管疾病。这种多因素疾病常导致视力损害。RVO的一些危险因素可进行预防性管理。鉴于RVO复杂的生理病理学，大多数最新治疗策略聚焦于继发性临床特征（如黄斑水肿和新生血管形成）。
本文作者回顾了正在进行的、前瞻性、开放标签的RVO新型治疗方法的I期和II期临床试验（主要是玻璃体内注射类固醇和抗VEGF药物）。具体而言，他们回顾了临床开发中与创新药物相关的药代动力学、安全性概况、研究设计和不良事件。
一些创新的早期临床试验基于抗VEGF药物和类固醇的联合治疗。有充分证据表明RVO的早期治疗具有临床益处。现在需要进行更大规模的随机研究，以更好地了解患者选择、治疗时机和剂量，从而优化新药和医疗器械的使用。
