Follow-up Study: Comparison of AMD Treatments Trial (CATT)

后续研究：AMD 治疗试验比较 (CATT)

• 批准号: 8918790
• 负责人: MAUREEN G MAGUIRE
• 金额: $ 5.38万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 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 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8918790
• 关键词: Adopted; Age related macular degeneration; Anatomy; Avastin; Choroidal Neovascularization; Clinical; Clinical Trials; Data; Enrollment; Exudative age-related macular degeneration; Eye; Fluorescein Angiography; Fundus photography; Health; Industry; Injection of therapeutic agent; Label; Legal Blindness; Long-Term Effects; Lucentis; Measurement; Morphology; National Eye Institute; Newly Diagnosed; Ophthalmologist; Optics; Outcome; Patients; Pharmaceutical Preparations; Process; Randomized; Randomized Clinical Trials; Retinal; Safety; United States; United States Food and Drug Administration; Vascular Endothelial Growth Factors; Vision; Visual Acuity; Western World; bevacizumab; comparative efficacy; follow-up; improved; outcome forecast; ranibizumab; tomography; treatment trial

Historically, age-related macular degeneration (AMD) has been the leading cause of legal blindness throughout the western world. However, the prognosis for newly diagnosed patients improved dramatically in 2005 when the1-year results of randomized clinical trials showed that monthly injections of ranibizumab (Lucentis), a drug directed towards vascular endothelial growth factor (anti-VEGF), was highly effective in preserving visual acuity. While ranibizumab was in process for approval by the Food and Drug Administration, ophthalmologists adopted off label use of a closely related but untested drug, bevacizumab (Avastin) after observing immediate results on vision and retinal morphology similar to those with Lucentis. CATT, sponsored by the National Eye Institute, was initiated in 2008 to compare the efficacy and safety of the 2 drugs and to determine if less than monthly administration compromised vision. CATT 2-year results showed that the two drugs provided similar effects on vision and that patients treated monthly gained approximately one-half line more vision. While 2-year visual acuity was quite good, morphologic changes that could progress to damage vision were present in some eyes in all treatment groups The Comparison of AMD Treatment Trials (CATT) Follow-up Study will provide new information on the long-term (about 5 year) vision and morphologic outcomes for eyes of patients treated with anti-VEGF drugs. Patients who were enrolled and treated for 2 years for choroidal neovascularization within the CATT randomized clinical will return to one of 42 CATT clinical centers for measurement of visual acuity, optical coherent tomography (OCT), and fundus photography including fluorescein angiography. Previous large-scale clinical trials sponsored by industry have not provided reliable data on the long term effects of treatment. Nearly all patients in the United States with neovascular AMD are treated with anti-VEGF drugs and the long-term effects are extremely important to both patients and their ophthalmologists. Findings from the CATT Follow-up Study will provide patients and ophthlamologists with information on long- term results on vision and anatomic changes in eyes treated for neovascular AMD with anti-VEGF treatments.

从历史上看，与年龄相关的黄斑变性（AMD）一直是整个西方世界的法律失明的主要原因。然而，在2005年，新诊断的患者的预后大大改善了，当时随机临床试验的1年结果表明，针对血管内皮生长因子（抗VEGF）的一种每月注射Ranibizumab（Lucentis），这是一种在保持视视率方面非常有效的。尽管雷尼单抗正在接受食品药品监督管理局的批准，但眼科医生在观察到与卢金蒂斯类似的视力和视网膜形态的立即结果后，采用了与密切相关但未测试的药物贝伐单抗（avastin）的标签使用。由国家眼科研究所（National Eye Institute）赞助的卡特（Catt）于2008年启动，以比较两种药物的疗效和安全性，并确定是否少于每月的管理妥协视力。 CATT 2年的结果表明，这两种药物对视力产生了相似的影响，并且每月治疗的患者获得了大约一半的视力。虽然两年视力相当不错，但在所有治疗组中，某些眼睛中都存在可能发展为损害视力的形态变化 AMD治疗试验（CATT）随访研究的比较将提供有关抗VEGF药物治疗的患者眼睛的长期（约5年）视力和形态结局的新信息。在CATT随机临床内接受了脉络膜新血管化的入学并接受治疗的患者将返回到42个CATT临床中心之一，用于测量视力，光学相干断层扫描（OCT）和包括荧光素血管造影的眼镜摄影。以前由行业赞助的大规模临床试验尚未提供有关治疗长期影响的可靠数据。美国几乎所有患有新血管AMD的患者均接受抗VEGF药物治疗，长期影响对患者及其眼科医生都非常重要。 CATT随访研究的结果将为患者和眼科医生提供有关长期视力和解剖学变化的信息，并通过抗VEGF治疗进行了新生血管AMD。