A Randomized, Double-Masked, Dose-Ranging, Multi-Center, Phase II Study Comparing the Safety and Efficacy of OT-551 With Placebo to Treat Geographic Atrophy Associated With Age-Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 198
- 主要终点
- Change in the area of GA
研究概览
简要总结
The purpose of this trial is to compare the ability of two doses of OT-551 ophthalmic solution and drug-free solution to safely and effectively treat geographic atrophy associated with age-related macular degeneration.
详细描述
Age-related macular degeneration (AMD) results in severe, irreversible central vision loss and is the leading cause of blindness in individuals older than 50 years in the western world. The vast majority of AMD patients have the 'dry' (non-exudative) form that is characterized by the presence of drusen and atrophic changes in the retinal pigment epithelium (RPE). Dry AMD may remain static or progress slowly to produce areas of geographic atrophy (GA), the advanced or late-stage form of dry AMD. GA is a severe vision-threatening lesion of the macula that may impair visual function, impact daily life activities, and result in blindness. Currently, there is no approved treatment for dry AMD or GA. Pre-clinical results have shown that OT-551 may protect RPE cells and photoreceptors from oxidative damage and block angiogenesis stimulated by VEGF and other growth factors, and therefore is a therapeutic candidate for treating GA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have a clinical diagnosis of GA in one or both eyes;
- •be of non-childbearing potential
排除标准
- •have GA secondary to any condition other than AMD in the study eye;
- •have a BCVA of 20/200 or worse in the non-study eye;
- •have a history of or current choroidal neovascularization in either eye, or the need for any study eye anti-angiogenic therapy;
- •have any ocular condition in the study eye that would progress during the course of the study and could affect central vision or other ocular conditions that may be a confounding factor in this study;
- •need to wear contact lenses in the study eye during the study;
- •had confounding ocular surgery in the study eye;
- •have concomitant treatment with any systemic or ocular medication that is known to be toxic to the lens, retina, or optic nerve;
研究组 & 干预措施
1
OT-551 0.3% ophthalmic solution
干预措施: OT-551 (Drug)
2
OT-551 0.45% ophthalmic solution
干预措施: OT-551 (Drug)
3
vehicle placebo
干预措施: vehicle placebo (Drug)
结局指标
主要结局
Change in the area of GA
时间窗: 2 years
次要结局
未报告次要终点