SCORE2 Comparative Trial (SCT)

SCORE2 比较试验 (SCT)

基本信息

批准号：
8920756
负责人：
BARBARA A BLODI
金额：
$ 6.36万
依托单位：
UNIVERSITY OF WISCONSIN-MADISON
依托单位国家：
美国
项目类别：
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/8920756
关键词：
Address Affinity Aftercare Ancillary Study Antibodies Binding Blindness Blood Vessels Caring Characteristics Chimeric Proteins Clinical Clinical Research Clinical Trials Complement Factor B Consensus Diabetic Retinopathy Disease Dose Early treatment Eye Funding Generations Goals Grant Growth Factor Health Immunoglobulin Fragments Injection of therapeutic agent Length Letters Mission NIH Program Announcements National Eye Institute Optical Coherence Tomography Outcome Outcomes Research Participant Patients Perfusion Peripheral Pharmaceutical Preparations Pharmacologic Substance Phase I Clinical Trials Phase II Clinical Trials Phase III Clinical Trials Principal Investigator Protein Isoforms Protocols documentation Randomized Regimen Reporting Research Research Personnel Research Project Grants Research Proposals Retina Retinal Retinal Vein Occlusion Safety Secondary to Secure Testing Thick Treatment Factor Treatment Protocols United States National Institutes of Health Vision Visual Visual Acuity adaptive optics age related aptamer base bevacizumab central retinal vein occlusion clinical effect comparative effectiveness comparative treatment comparative trial effectiveness research evidence base factor A impression improved intravitreal injection macula macular edema meetings optical imaging patient population pegaptanib prognostic programs prospective randomized trial ranibizumab receptor response retina circulation disorder standard of care trial comparing

项目摘要

DESCRIPTION (provided by applicant): The Studies of Comparative Treatments for REtinal Vein Occlusion 2 (SCORE2) is a phase III trial to study patients with central retinal vein occlusion. This comparative effectiveness research proposal aims to support a multicenter, prospective, randomized, phase III clinical trial to compare treatment protocols for decreased vision due to macular edema secondary to central retinal vein occlusion (CRVO). Currently, two anti-vascular endothelial grown factor (VEGF) compounds, bevacizumab and ranibizumab, have become first-line therapy in CRVO eyes that have vision loss due to macular edema. The newest anti-VEGF molecule, aflibercept, was recently shown to be effective in patients with macular edema due to CRVO in the COPERNICUS Study sponsored by Regeneron Pharmaceuticals Inc (Tarrytown, NY). The SCORE2 trial is a noninferiority trial between a first generation anti-VEGF treatment, bevacizumab, and a second generation anti-VEGF treatment, aflibercept. The noninferiority margin will be set at an Early Treatment Diabetic Retinopathy Study visual acuity letter score of 5. In SCORE2, patients will be assigned randomly to 1) intravitreal aflibercept every 4 weeks or 2) intravitreal bevacizumab every 4 weeks. The primary noninferiority comparison between the 2 groups will be performed at 6 months. At 6 months, participants assigned to aflibercept injection at baseline that meet the criteria for a good response will be randomized to either continuing aflibercept every 4 weeks vs. changing to a fixed regimen of every 8 weeks. This will allow for an assessment of whether a fixed regimen of every 8 week injections can produce visual results similar to continued treatment Q4 weeks. At 6 months, participants assigned to bevacizumab at baseline that meet the criteria for a good response will be randomized to either continuing bevacizumab injection every 4 weeks vs. changing to a pro re nata (PRN) regimen with monthly assessement. This will allow for an assessment of whether a PRN regimen can produce visual results similar to continued treatment every 4 weeks. All participants will be followed for 13 months.

描述（由申请人提供）：视网膜静脉闭塞2（Score2）的比较治疗研究是研究中央视网膜静脉闭塞患者的III期试验。这项比较有效性研究建议旨在支持多中心，前瞻性，随机，III期临床试验，以比较因继发于中央视网膜静脉闭塞（CRVO）的黄斑水肿而减少视力的治疗方案。目前，两种抗血管内皮增长因子（VEGF）化合物Bevacizumab和Ranibizumab已成为CRVO Eyes的一线疗法，这些疗法因黄斑水肿而导致视力丧失。最新的抗VEGF分子Aflibercept最近被证明在Regeneron Pharmaceuticals Inc（纽约州Tarrytown）赞助的哥白尼研究中，由于CRVO而导致的黄斑水肿患者有效。 Score2试验是第一代抗VEGF治疗（贝伐单抗）和第二代抗VEGF治疗（Aflibercept）之间的非劣势试验。非劣缘边缘将在早期治疗的糖尿病性视网膜病变研究视力字母评分为5。在Score2中，将随机分配为1）玻璃体内aflibercept每4周或2）每4周一次玻璃体内bevacizumab。两组之间的主要非效率比较将在6个月后进行。在6个月的时间里，在基线时分配给Aflibercept注入的参与者符合良好响应标准的参与者将被随机分配为每4周继续进行一次Aflibercept，而更改为每8周的固定方案。这将允许评估每8周注射一次固定方案是否可以产生类似于继续治疗的Q4周的视觉结果。在基线上分配给Bevacizumab的6个月时，符合良好响应标准的参与者将被随机分配为每4周继续进行贝伐单抗注射，而不是更改为每月评估的Pro NATA（PRN）治疗方案。这将允许评估PRN方案是否可以产生类似于每4周继续治疗的视觉结果。所有参与者将被遵循13个月。