SCORE2 Comparative Trial (SCT)

描述（由申请人提供）：本比较有效性研究提案（视网膜静脉阻塞比较治疗研究2 [SC 0 RE 2]研究）旨在基于近期随机试验的结果，支持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替代治疗方案。这项被称为“SCORE 2比较试验”（SCT）的拟议研究将确定贝伐单抗在治疗RVO所致黄斑水肿方面是否不劣于阿柏西普。非劣效性界值将设定为早期治疗糖尿病视网膜病变研究视力字母评分5。SCT还将提供对最初6个月后的治疗方案的了解，以确定是否可以减少对治疗反应良好的眼睛的玻璃体内注射频率（这将是一种更具成本效益的治疗方案，患者发生注射相关不良事件的风险更低，患者和提供者的后勤治疗负担更轻），以及替代治疗策略（玻璃体内地塞米松）在对抗VEGF治疗的初始治疗反应不佳的眼睛中的影响。因此，除了检验贝伐珠单抗在第6个月时眼睛视力结局方面非劣效于阿柏西普的主要目的外，次要目的还将研究不同的 第6个月后的给药策略。此外，次要分析将基于SD-OCT和宽视野荧光素血管造影检查视网膜增厚和其他视网膜结局（在一个研究中心子集内）。SCT还将增加我们对这些抗血管内皮生长因子（抗VEGF）药物安全性的了解。我们建议在24个月内招募360名CRVO患者，并随访13个月。此应用程序是为EMMES公司作为SCT的数据协调中心（DCC），我们的主要重点是提供数据管理，统计和运营支持超过5年的支持。

DESCRIPTION (provided by applicant): This comparative effectiveness research proposal (Studies of Comparative Treatments for Retinal Vein Occlusion 2 [SC0RE2] Study) aims to support alternative treatment protocols for decreased vision due to macular edema secondary to central retinal vein occlusion (CRVO) based on results of recent randomized trials. This proposed study called the "SCORE2 Comparative Trial" (SCT) will determine if bevacizumab is non-inferior to aflibercept for the treatment of macular edema due to RVO. The non-inferiority margin will be set at an Early Treatment Diabetic Retinopathy Study visual acuity letter score of 5. The SCT will also provide insight into treatment regimens after the initial 6 months to determine if the frequency of intravitreal injections can be reduced in eyes that have responded well to treatment (which would represent a more cost-effective treatment regimen, with fewer risks to patients of injection-related adverse events and a lesser logistical treatment burden for patients and providers), and the impact of alternative treatment strategies (intravitreal dexamethasone) in eyes that have not responded well to initial treatment with anti-VEGF therapy. So, in addition to the primary aim of test for non-inferiority of bevacizumab to aflibercept in visual acuity outcome at Month 6 for eyes, secondary aims will investigate different dosing strategies after Month 6. In addition, secondary analyses will examine retinal thickening and other retinal outcomes based on SD-OCT and wide field fluorescein angiograms (within a subset of sites). The SCT will also add to our knowledge of the safety profile of these anti-vascular endothelial growth factor (anti-VEGF) medications. We propose to enroll 360 CRVO patients over a 24-month period, and follow for 13-months. This application is for The EMMES Corporation to serve as the Data Coordinating Center (DCC) for the SCT, with our primary focus to provide data management, statistical, and operational support over 5 years of support.