A Phase II Study of OT-551 Antioxidant Eye Drop

视网膜相关性黄斑变性（AMD）是美国55岁以上人群失明的主要原因，是一种异质性临床实体，其中视网膜变性在衰老的背景下主要发生在黄斑中，并主要导致中心视敏度受损。AMD以两种一般形式发生，其中一种涉及脉络膜下新血管形成，随后形成网状瘢痕。第二种形式，也是本研究的主题，被称为“干性”或萎缩性黄斑变性，涉及一系列临床特征，包括玻璃疣、色素结块和/或视网膜色素上皮（RPE）脱落和地图状萎缩。地图状萎缩可以开始为RPE变薄，并涉及下面的脉络膜毛细血管，随后导致黄斑的萎缩性变化。萎缩性AMD患者的唯一疗法是含有高剂量抗氧化剂和锌的口服补充剂，由国家眼科研究所（NEI）在一项大型、多中心、双盲、安慰剂对照临床试验中进行了测试，平均参与者随访约6年。这种抗氧化剂疗法显示出适度延缓干性AMD从中期到晚期的进展，并证实了这种疾病的治疗益处。 Alcoha Pharmaceuticals的Alcoha（OT）-551抗氧化滴眼液具有长期治疗干性老年性黄斑变性的潜力。这项在多达10名患有双侧地图状萎缩的滴眼剂耐受性受试者中进行的初步研究旨在表征0.45%浓度的OT-551滴眼剂每日3次给药在两年期间对地图状萎缩区域进展的影响。受试者的一只眼睛将随机接受滴眼液，对侧眼睛将仅进行观察。

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.