A Phase II Study of OT-551 Antioxidant Eye Drop

OT-551抗氧化滴眼液的II期研究

• 批准号: 7975942
• 负责人: DARBY THOMPSON
• 金额: $ 13.93万
• 依托单位: THE EMMES COMPANY, LLC
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-11-01 至 2011-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7975942
• 关键词: Phase; II; Study; OT; 551

Age-related Macular Degeneration (AMD), the leading cause of blindness in people over age 55 in the U.S. is a heterogeneous clinical entity in which retinal degeneration occurs predominantly in the macula in the context of aging and leads to impairment primarily of central visual acuity. AMD occurs in two general forms, one of which involves subchoroidal neovascularization with subsequent formation of a disciform scar. A second form, and the subject of this study, is termed "dry" or atrophic macular degeneration and involves a constellation of clinical features that can include drusen, pigment clumping and/or retinal pigment epithelium (RPE) dropout, and geographic atrophy. Geographic atrophy can begin as a thinning of the RPE with involvement of the underlying choriocapillaris and lead subsequently to an atrophic change in the macula. The only therapy for persons with atrophic AMD is an oral supplement containing high doses of antioxidants and zinc, which was tested by the National Eye Institute (NEI) in a large, multicenter, double-masked, placebo-controlled clinical trial with average participant follow-up of about 6 years. This antioxidant therapy was shown to modestly retard the progression of dry AMD from an intermediate stage to the advanced stages and confirmed the benefit of therapy in this disease. Othera Pharmaceuticals' Othera (OT)-551 antioxidant eye drop has the potential for chronic treatment of the dry form of age-related macular degeneration. This pilot study of up to 10 eye drop tolerant participants with bilateral geographic atrophy is designed to characterize the effect of 0.45% concentration of OT-551 eye drops given 3 times a day on the progression of geographic atrophy area over a two-year period. Participants will have one eye randomized to receive the eye drop and the fellow eye will be observed only.

年龄相关性黄斑变性(AMD)是美国55岁以上人群致盲的主要原因，是一种异质性的临床实体，其视网膜变性主要发生在衰老背景下的黄斑，并主要导致中央视力的损害。AMD有两种常见形式，一种是脉络膜下新生血管，随后形成盘状瘢痕。第二种类型，也是本研究的主题，称为“干性”或萎缩性黄斑变性，涉及一系列临床特征，包括玻璃体、色素团块和/或视网膜色素上皮(RPE)脱落，以及地域性萎缩。地理性萎缩可始于视网膜色素上皮变薄，累及脉络膜毛细血管，继而导致黄斑的萎缩改变。对萎缩性AMD患者的唯一治疗方法是一种含有高剂量抗氧化剂和锌的口服补充剂，该补充剂由美国国家眼科研究所(NEI)在一项大型、多中心、双盲、安慰剂对照的临床试验中进行测试，平均参与者随访约6年。这种抗氧化剂疗法被证明适度地延缓了干性AMD从中期到晚期的进展，并证实了该疗法在这种疾病中的益处。 其他A制药公司的其他A(OT)-551抗氧化剂滴眼液有可能用于慢性治疗干性老年性黄斑变性。这项对多达10名患有双侧地理萎缩的眼药水耐受性参与者进行的初步研究旨在表征0.45%浓度的OT-551滴眼液在两年内对地理萎缩区域进展的影响，每天3次。参与者的一只眼睛将被随机接受滴眼剂，而另一只眼睛将只被观察。