A Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Phase 2 Study to Evaluate the Efficacy and Safety of Oral CT1812 in Participants With Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration (AMD).
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 19
- 主要终点
- Change from baseline in Geographic Atrophy (GA) lesion area over 104 weeks in the study eye.
研究概览
简要总结
This is a Phase 2, prospective, multicenter, randomized, double-masked, placebo-controlled 104-week study to assess the efficacy, safety, and tolerability of orally delivered CT1812 compared to placebo in participants with GA associated with dry AMD.
详细描述
This is a Phase 2, prospective, multicenter, randomized, double-masked, placebo-controlled 104-week study to assess the efficacy, safety, and tolerability of orally delivered CT1812 compared to placebo in participants with GA associated with dry AMD.
Participants ≥50 years old diagnosed with GA secondary to dry AMD and who meet all inclusion criteria and none of the exclusion criteria will be included in the study. The study will randomize up to 246 participants in a 1:1 manner (123 participants per treatment group) to receive a single daily dose of either CT1812 (200 mg) or placebo across approximately 40-50 sites.
Following a screening period of up to 60 days, the total expected duration of participant participation in the study will be 108 weeks (104-week treatment period followed by a 28-day [4-week] post treatment safety follow up period).
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥50 years at time of informed consent.
- •BCVA of 24 letters or better using Early Treatment Diabetic Retinopathy Study (ETDRS) charts at screening.
- •Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening.
- •EXCLUSION CRITERIA:
- •GA due to causes other than dry AMD.
- •Any history or current evidence of exudative ("wet") AMD.
- •Retinal disease other than dry AMD.
- •Any ophthalmologic condition that prevents adequate imaging of the retina as judged by the study site or central reading center.
- •Intraocular surgery (including intraocular lens implantation surgery) within 3 months prior to randomization.
- •Any ophthalmic condition that will or is likely to require surgery during the study period.
- •Hypersensitivity to fluorescein.
- •Suspected or known allergy to any components of the study treatments.
- •History of vitrectomy surgery, submacular surgery or any other surgical intervention for dry AMD.
- •History of glaucoma filtering surgery or corneal transplant in the study eye.
- •History of central serous retinopathy in either eye.
排除标准
- 未提供
研究组 & 干预措施
CT1812 200 mg
Drug: CT1812 Active Study Drug
干预措施: Active Comparator CT1812 (Drug)
Placebo
Placebo
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Change from baseline in Geographic Atrophy (GA) lesion area over 104 weeks in the study eye.
时间窗: Baseline through Week 104
Compare the mean rate of growth (slope) in GA lesion area in the study eye measured by fundus autofluorescence imaging (FAF).
次要结局
- Safety and Tolerability of CT1812(Baseline through Week 104)
- Plasma concentration of CT1812(Baseline through Week 104)