The SCORE2 Long-Term Follow-Up (SCORE2 LTF)

项目摘要 SCORE2长期跟进(SCORE2 LTF)建议旨在描述长期(3-、4- 和5年)接受CRVO或HRVO治疗的SCORE2参与者的眼睛结果 黄斑水肿联合抗血管内皮生长因子(抗血管内皮生长因子)治疗。学习 结果包括视力，需要继续治疗，并发症的发展 CRVO或HRVO、生活质量和形态结局。抗血管内皮生长因子治疗是治疗的标准 CRVO或HRVO所致黄斑水肿所致视力丧失的一线治疗； 尽管如此，目前还没有可靠的数据显示CRVO患者的远期疗效。 抗血管内皮生长因子治疗。在SCORE2 LTF中，跟随SCORE2的参与者将返回以下其中之一 3、4、5年共66个SCORE2临床点位进行视力和眼内测量 眼压(IOP)、裂隙灯和扩张眼底镜检查，以及光谱域光学检查 相干断层扫描(SD-OCT)。每次年度访问后约6个月(按3.5年 和4.5)，将通过电话联系参与者，以了解任何系统和眼睛的最新情况 自年度访问以来发生的事件。由于SCORE2 LTF旨在遵循 在“真实世界”环境中的参与者，SCORE2调查人员将不会被提供研究药物 或再次治疗CRVO所致黄斑水肿的建议 或在SCORE2 LTF期间的HRVO，从而允许收集关于治疗类型和 临床上通常提供给CRVO和HRVO患者的治疗模式 布景。这些信息将对患者和他们的治疗眼科医生有价值 尊重他们在抗血管内皮生长因子治疗次数和视力方面的预期 CRVO或HRVO患者的预后。眼底照相、荧光素血管造影术和 生活质量评估将每年进行一次。将执行分析以满足 以下目标：1)比较5年来接受治疗的研究参与者的视力 最初使用两种抗血管内皮生长因子药物(贝伐单抗和阿普利赛特)之一；2)描述3-、4-和 接受治疗的眼睛的5年视力、形态和生活质量结果以及安全概况 使用抗血管内皮生长因子药物治疗CRVO或HRVO引起的黄斑水肿；3)描述 CRVO/HRVO所致黄斑水肿的治疗(治疗次数、持续时间和类型) 以及视力、形态和生活质量的时间关系；4) 调查基线因素与长期视力，形态， 和生活质量结果；5)比较评分的自然病史3年结果- CRVO试验：抗血管内皮生长因子治疗的SCORE2眼的3、4和5年结果。

Project Summary The SCORE2 Long-Term Follow-Up (SCORE2 LTF) proposal aims to describe long-term (3-, 4- and 5-year) outcomes of eyes from SCORE2 participants with CRVO or HRVO treated for macular edema with anti-vascular endothelial growth factor (anti-VEGF) therapy. Study outcomes include visual acuity, need for continuing treatment, development of complications of CRVO or HRVO, quality of life, and morphologic outcomes. Anti-VEGF therapy is the standard of care first-line treatment for vision loss attributable to macular edema due to CRVO or HRVO; despite this, there are no reliable data on long-term outcomes of eyes with CRVO treated with anti-VEGF therapy. In the SCORE2 LTF, participants followed in SCORE2 will return to one of 66 SCORE2 clinical sites at Years 3, 4 and 5 for measurement of visual acuity and intraocular pressure (IOP), slit-lamp and dilated funduscopic examinations, and spectral domain optical coherence tomography (SD-OCT). Approximately 6 months after each annual visit (at years 3.5 and 4.5), participants will be contacted by telephone for an update on any systemic and ocular events that have occurred since the annual visits. Since the SCORE2 LTF is intended to follow participants in a “real-world” setting, SCORE2 investigators will not be provided with study drug or re-treatment recommendations for the management of the macular edema due to the CRVO or HRVO during SCORE2 LTF, thus allowing the gathering of data on types of treatment and treatment patterns that would typically be provided to CRVO and HRVO patients in a clinical setting. This information will be valuable to patients and their treating ophthalmologists with respect to what they can expect in terms of number of anti-VEGF treatments and visual acuity prognosis in patients with CRVO or HRVO. Fundus photography, fluorescein angiography, and quality of life assessment will be performed annually. Analyses will be performed to meet the following objectives: 1) compare visual acuity through 5 years for study participants treated initially with one of two anti-VEGF drugs (bevacizumab and aflibercept); 2) describe 3-, 4-, and 5-year visual acuity, morphologic, and quality of life outcomes, and safety profile, in eyes treated with anti-VEGF agents for macular edema due to CRVO or HRVO; 3) describe patterns of treatment for macular edema due to CRVO/HRVO (number, duration and type of treatments) and the temporal relationship with visual acuity, morphologic, and quality of life outcomes; 4) investigate the association between baseline factors and long-term visual acuity, morphologic, and quality of life outcomes; 5) compare of the natural history 3-year outcomes of the SCORE- CRVO trial with the 3-, 4- and 5-year outcomes of anti-VEGF-treated SCORE2 eyes.