The Safety and Efficacy of AL-8309B Ophthalmic Solution for the Treatment of Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 772
- 主要终点
- Mean Annualized Lesion Enlargement Rate From Baseline as Assessed With Fundus Autofluorescence Imaging
研究概览
简要总结
The purpose of this study was to evaluate the safety and efficacy of AL-8309B Ophthalmic Solution versus Vehicle administered as a topical ocular drop for the treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
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
- •Willing to give written informed consent, make required study visits, and follow instructions.
- •Able to administer eye drops or have a caretaker to administer the eye drops.
- •Study eye: Atrophy secondary to age-related macular degeneration, best corrected visual acuity (BCVA) of 35 letters (20/200 Snellen equivalent) or better, clear ocular media, and adequate pupillary dilation.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Pregnant, nursing, or not using adequate contraception.
- •Ocular disease in the study eye, other than non-exudative AMD.
- •History of cataract surgery in either eye within the past 3 months of screening.
- •History or evidence of serious ocular trauma or intraocular surgery in either eye within the past 6 months of screening.
- •Any medical condition that would make participation in the trial or adherence to the study schedule difficult or unlikely.
- •Participation in an investigational drug or device study within 30 days of screening.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
AL-8309B 1.0%
AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
干预措施: AL-8309B Ophthalmic Solution (Drug)
AL-8309B 1.75%
AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
干预措施: AL-8309B Ophthalmic Solution (Drug)
Vehicle
AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
干预措施: AL-8309B Vehicle (Drug)
结局指标
主要结局
Mean Annualized Lesion Enlargement Rate From Baseline as Assessed With Fundus Autofluorescence Imaging
时间窗: Baseline, up to Month 30
The size of the retinal lesion was measured using the Heidelberg Retinal Angiography system at Baseline, Month 6, Month 12, Month 15, Month 18, Month 24, and Month 30. Images were collected in both eyes; however, one eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. Results were estimated from a longitudinal random effects regression model. A greater lesion growth rate may indicate a faster progression of the disease.
次要结局
未报告次要终点