A Multicentre, Natural History, Non-interventional Study Evaluating Biomarkers In Participants With Geographic Atrophy(GA) Secondary To Age-Related Macular Degeneration (AMD)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
- 试验地点
- 22
- 主要终点
- Levels of complement proteins
研究概览
简要总结
An observational study to investigate the natural history and evaluate biomarkers of participants with geographic atrophy secondary to age-related macular degeneration
详细描述
Prospective, observational study to assess the relationships between circulating levels of complement proteins measured using the Complement Precision Medicine (CPM) Platform, genetic profile and lesion progression in subjects with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD) up to a 24-month period
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of bilateral GA due to AMD as confirmed by fundoscopy and imaging at Screening
- •GA lesion sizes of ≥ 1.25 mm2 to ≤ 17 mm2 (approximately 1-7 disc diameters) in at least one eye as per Central Reading Center
- •Willing and able to provide written informed consent
- •Male or female aged 65 years and over
排除标准
- •History of neovascular (wet) AMD or presence of neovascular (wet) AMD in either eye confirmed by fundoscopy at screening and/or any pre-existing retinal imaging
- •History of intravitreal (IVT) injection in the study eye. Note: Intravitreal treatment with pegcetacoplan (Syfovre®) and avacincaptad pegol (IzervayTM) if approved within the participant's country of origin AND if deemed necessary by the Principal Investigator (PI) is allowed in the fellow eye only. IVT injections in the study eye are prohibited.
- •History of uveitis or endophthalmitis
- •High myopia (more than 6 diopter) in the study eye
- •Any ocular pathology which would impede clear imaging of the macula, e.g. intra-ocular opacities
- •Macular changes from causes other than AMD
- •Diabetic retinopathy in either eye. Note: Presence of systemic diabetes with no retinopathy is not exclusionary
- •Any other physical condition which would prevent the participant from undertaking imaging procedures
- •Any cell or gene therapy in either eye
结局指标
主要结局
Levels of complement proteins
时间窗: Month 6, 12,18, 24
To assess the correlation between circulating levels of complement proteins measured using the Complement Precision Medicine (CPM) Platform and Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD)
次要结局
- Choroidal Blood Flow and GA Lesion Progression(Up to 24 months)
- CRP Levels(Up to 24 months)
- Geographic Atrophy(Up to 24 months)
- Genetics(Up to 24 months)
- Complement Proteins Intra-individual Variation(Up to 24 months)
- Complement Proteins and Progression of GA(Up to 24 months)
- Choroidal Blood Flow and Genetics(Up to 24 months)