SCORE2 Comparative Trial (SCT)

SCORE2 比较试验 (SCT)

• 批准号: 8991948
• 负责人: BARBARA A BLODI
• 金额: $ 9.06万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 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/8991948
• 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; phase III trial; prognostic value; programs; prospective; randomized trial; ranibizumab; receptor; response; retina circulation disorder; standard of care; trial comparing

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）：视网膜静脉阻塞比较治疗研究 2 (SCORE2) 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，以比较因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) 化合物贝伐珠单抗和雷珠单抗已成为因黄斑水肿导致视力丧失的 CRVO 眼的一线治疗方法。最新的抗 VEGF 分子阿柏西普最近在再生元制药公司（纽约塔里敦）赞助的哥白尼研究中被证明对 CRVO 引起的黄斑水肿患者有效。 SCORE2 试验是第一代抗 VEGF 治疗贝伐珠单抗和第二代抗 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。在 SCORE2 中，患者将被随机分配至 1) 每 4 周玻璃体内注射阿柏西普或 2) 每 4 周玻璃体内注射贝伐单抗。两组之间的主要非劣效性比较将在 6 个月时进行。 6 个月时，在基线时分配阿柏西普注射且符合良好反应标准的参与者将被随机分配，要么继续每 4 周注射一次阿柏西普，要么改为每 8 周注射一次固定方案。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持续治疗第 4 周类似的视觉结果。 6 个月时，在基线时分配到贝伐单抗且符合良好反应标准的参与者将被随机分配，要么每 4 周继续注射贝伐单抗，要么改为每月评估的 Pro re nata (PRN) 方案。这将允许评估 PRN 方案是否可以产生与每 4 周持续治疗类似的视觉效果。所有参与者都将被跟踪 13 个月。