SCORE2 Comparative Trial (SCT)

描述(申请人提供)：这项比较有效性研究提案旨在支持一项多中心、前瞻性、随机、NIH定义的III期临床试验，以基于最近的随机试验结果，比较继发于视网膜中央静脉阻塞(CRVO)的黄斑水肿所致视力下降的治疗方案。本申请是一个由研究人员发起的项目，以响应编号为PAR-10-207的计划。这项试验旨在评估贝伐单抗在治疗CRVO引起的黄斑视网膜病变引起的视力下降方面是否不逊于afLibercept(具有测试优势的能力)。主要目的是根据6个月时视力字母评分的平均变化来测试非劣势，每4周随机接受贝伐单抗治疗的眼与每4周随机接受玻璃体内注射贝伐单抗的眼进行比较，使用5个字母的非劣势差值。次要目标是：比较贝伐单抗和阿普利康两组在6个月时的中心视网膜厚度以及用光谱域光学相干断层扫描(SD-OCT)测量的基线和6个月之间的变化；评估治疗反应良好(根据方案定义)的参与者在6个月后与不同剂量策略相关的第13个月视力和SD-OCT结果；评估对治疗反应差(根据方案定义)的参与者在6个月后与替代治疗策略相关的第13个月视力和SD-OCT结果；比较贝伐单抗和Free afcept组CRVO的新生血管并发症发生率；除了我们对这些抗血管内皮生长因子(抗血管内皮生长因子)药物在治疗继发于CRVO的黄斑水肿的眼部环境中的安全性方面的了解外，大约80个临床中心将总共招募360名参与者。参与者将被跟踪13个月，评估包括早期治疗糖尿病视网膜病变研究(ETDRS)视力字母评分，SD-OCT，立体眼底照相，以及在选定地点进行宽视场荧光素血管造影术。将根据频率和严重程度监测潜在的不良事件。

DESCRIPTION (provided by applicant): This comparative effectiveness research proposal aims to support a multicenter, prospective, randomized, NIH-defined phase III clinical trial to compare treatment protocols for decreased vision due to macular edema secondary to central retinal vein occlusion (CRVO) based on results of recent randomized trials. This application is an investigator-initiated project in response to Program Anouncement Number PAR-10-207. The trial is designed to assess whether bevacizumab is non-inferior to aflibercept (with the ability to test for superiority) for the treatment of decreased vision attributable to macular edem due to CRVO. The primary aim is to test for non-inferiority based on mean change from baseline in visual acuity letter score at Month 6 for eyes randomized to intravitreal bevacizumab every 4 weeks compared with eyes randomized to intravitreal aflibercept every 4 weeks using a non-inferiority margin of 5 letters. Secondary aims are to: compare the bevacizumab and the aflibercept groups in central retinal thickness at Month 6 and change between baseline and Month 6 as measured with spectral domain optical coherence tomography (SD-OCT); assess Month 13 visual acuity and SD-OCT outcomes associated with different dosing strategies after Month 6 in participants who respond well (defined per protocol) to treatment; assess Month 13 visual acuity and SD-OCT outcomes associated with alternative treatment strategies after Month 6 in participants who respond poorly (defined per protocol) to treatment; compare rates of neovascular complications of CRVO in the bevacizumab vs. aflibercept groups; add to our knowledge of the safety profile of these anti-vascular endothelial growth factor (anti-VEGF) medications in the setting of eyes with macular edema secondary to CRVO A total of 360 participants will be enrolled at approximately 80 clinical centers. Participants will be followed fr 13 months, with assessments including Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity letter score, SD-OCT, stereoscopic fundus photography and, at selected sites, widefield fluorescein angiography. Potential adverse events will be monitored with respect to frequency and severity.