SCORE2 Comparative Trial (SCT)

SCORE2 比较试验 (SCT)

• 批准号: 8926101
• 负责人: PAUL C VAN VELDHUISEN
• 金额: $ 7.49万
• 依托单位: THE EMMES COMPANY, LLC
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-30 至 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8926101
• 关键词: Adverse event; Angiography; Applications Grants; Blindness; Caring; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Collaborations; Data; Data Collection; Data Coordinating Center; Data Quality; Data Reporting; Dexamethasone; Diabetic Retinopathy; Doctor of Philosophy; Dose; Early treatment; Electronics; Enrollment; Ensure; Exhibits; Eye; Fluorescein; Frequencies; Funding; Fundus photography; Generations; Goals; Grant; Health; Health Sciences; Implant; Industry; Injection of therapeutic agent; Leadership; Letters; Measures; Medicine; Monitor; NIH Program Announcements; Online Systems; Ophthalmology; Outcome; Outcome Measure; Outcomes Research; Participant; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Phase III Clinical Trials; Principal Investigator; Provider; Public Health; Quality Control; Randomized; Reading; Research; Research Personnel; Research Proposals; Resources; Retinal; Retinal Vein Occlusion; Risk; Safety; Sample Size; Secondary to; Secure; Site; Support System; Tail; Testing; Treatment Protocols; Universities; Vascular Endothelial Growth Factors; Vision; Visual; Visual Acuity; Wisconsin; alternative treatment; arm; base; bevacizumab; central retinal vein occlusion; clinical research site; college; comparative effectiveness; comparative treatment; comparative trial; cost effective; data management; design; effective therapy; effectiveness research; evidence base; improved; insight; intravitreal injection; macular edema; patient population; primary outcome; programs; prospective; quality assurance; randomized trial; response; safety study; secondary outcome; treatment strategy

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.

描述（由申请人提供）：这项比较有效性研究提案（视网膜静脉阻塞比较治疗研究 2 [SC0RE2] 研究）旨在根据最近的随机试验结果，支持针对视网膜中央静脉阻塞 (CRVO) 继发性黄斑水肿导致的视力下降的替代治疗方案。这项名为“SCORE2 比较试验”(SCT) 的拟议研究将确定贝伐珠单抗在治疗 RVO 引起的黄斑水肿方面是否不劣于阿柏西普。非劣效界值将设定为早期治疗糖尿病视网膜病变研究的视力字母评分为 5。SCT 还将深入了解最初 6 个月后的治疗方案，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（这将代表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较小，并且可减轻治疗的后勤负担） 患者和提供者），以及替代治疗策略（玻璃体内地塞米松）对抗 VEGF 治疗初始治疗反应不佳的眼睛的影响。因此，除了测试贝伐单抗与阿柏西普在第 6 个月眼睛视力结果中的非劣效性之外，次要目标还将调查不同的结果 第 6 个月后的剂量策略。此外，二次分析将根据 SD-OCT 和广域荧光素血管造影（在部分位点内）检查视网膜增厚和其他视网膜结果。 SCT 还将增加我们对这些抗血管内皮生长因子（抗 VEGF）药物的安全性的了解。我们建议在 24 个月的时间内招募 360 名 CRVO 患者，并随访 13 个月。该应用程序供 EMMES Corporation 作为 SCT 的数据协调中心 (DCC)，我们的主要重点是提供超过 5 年的数据管理、统计和运营支持。