SCORE2 Comparative Trial (SCT)

描述（由申请人提供）：The Studies of Comparative treatment for REtinal Vein Occlusion 2 （SCORE2）是一项研究视网膜中央静脉闭塞患者的III期试验。本比较有效性研究计划旨在支持一项多中心、前瞻性、随机、III期临床试验，以比较视网膜中央静脉阻塞（CRVO）继发黄斑水肿导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尼单抗已成为黄斑水肿导致视力丧失的CRVO眼的一线治疗方法。在Regeneron制药公司（Tarrytown， NY）赞助的COPERNICUS研究中，最新的抗vegf分子aflibercept最近被证明对CRVO引起的黄斑水肿患者有效。SCORE2试验是第一代抗vegf治疗药物贝伐单抗和第二代抗vegf治疗药物阿伯西普之间的一项非劣效性试验。非劣效性界限将设定为早期治疗糖尿病视网膜病变研究视力字母评分为5分。在SCORE2中，患者将被随机分配到1)每4周玻璃体内注射阿非利塞普或2)每4周玻璃体内注射贝伐单抗。两组间的主要非劣效性比较将在6个月时进行。在6个月时，受试者在基线时被分配给阿非利西普注射，满足良好反应的标准，将被随机分配到每4周继续阿非利西普或每8周改变固定方案。这将允许评估每8周注射一次的固定方案是否能产生与连续治疗4周相似的视觉效果。在6个月时，基线时被分配到贝伐珠单抗的符合良好反应标准的参与者将被随机分配到每4周继续注射贝伐珠单抗或改为每月评估的PRN方案。这将允许评估PRN方案是否能产生与每4周继续治疗相似的视觉结果。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.