NCT06990269招募中2 期
A Phase 2, Randomized, Masked, Placebo-Controlled Study of Subcutaneously Administered ADX-038 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 83
- 主要终点
- Evaluate the effect of ADX-038 on the preservation of the EZ layer
研究概览
简要总结
Phase 2 study is designed to assess the efficacy of ADX-038 compared with placebo in participants with GA secondary to AMD. Safety, pharmacokinetics (PK), and pharmacodynamics (PD) will also be assessed.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of GA of the macula secondary to AMD
- •GA lesions between 2.5 and 12.5 mm2 at screening
- •Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol
- •Willing and able to comply with clinic visits and study-related procedures, including completion of the full series of meningococcal vaccinations and pneumococcal vaccination required per protocol
排除标准
- •Has GA secondary to causes other than AMD
- •Has active ocular disease that compromises or confounds visual function
- •History of surgery for retinal detachment
- •Has ocular condition other than GA secondary to AMD
- •Use of intravitreal complement inhibitors in study eye
- •Hereditary or acquired complement deficiency
- •Active viral, bacterial or fungal infection
- •Liver injury as evidenced by abnormal liver function tests
- •Donating blood
- •History of choroidal neovascularization in the study eye
研究组 & 干预措施
Active - ADX-038
Experimental
干预措施: ADX-038 (Drug)
Placebo - Saline
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluate the effect of ADX-038 on the preservation of the EZ layer
时间窗: 12 months
Rate of change in the area of total EZ loss in the study eye from baseline to Month 12
次要结局
未报告次要终点
研究者
研究点 (83)
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