SCORE2 Comparative Trial (SCT)

描述（由申请人提供）：视网膜静脉阻塞比较治疗研究2（SCORE 2）是一项研究视网膜中央静脉阻塞患者的III期试验。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、III期临床试验，以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。目前，两种抗血管内皮生长因子（VEGF）化合物，贝伐单抗和雷珠单抗，已成为一线治疗的CRVO眼睛，视力丧失由于黄斑水肿。最新的抗VEGF分子aflibercept最近在由Regeneron Pharmaceuticals Inc（Tarrytown，NY）赞助的COPERNICUS研究中显示对CRVO所致黄斑水肿患者有效。SCORE2试验是第一代抗VEGF治疗（贝伐单抗）和第二代抗VEGF治疗（阿柏西普）之间的非劣效性试验。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。在评分2中，患者将被随机分配至1）每4周一次玻璃体内注射阿柏西普或2）每4周一次玻璃体内注射贝伐珠单抗。将在6个月时进行两组之间的主要非劣效性比较。在6个月时，在基线时被分配接受阿柏西普注射的符合良好反应标准的参与者将被随机分配至每4周一次继续阿柏西普或改为每8周一次的固定方案。这将允许评估每8周注射一次的固定方案是否可以产生与Q4周继续治疗相似的视觉结果。在6个月时，在基线时被分配接受贝伐珠单抗治疗且符合良好应答标准的受试者将被随机分配至继续每4周一次贝伐珠单抗注射组或变更为随机（PRN）方案，每月评估一次。这将允许评估PRN方案是否可以产生类似于每4周一次的持续治疗的视觉结果。所有参与者将被随访13个月。

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.