Non Exudative Age-Related Macular Degeneration Imaged With Swept Source Optical Coherence Tomography
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 225
- 试验地点
- 5
- 主要终点
- Change in Choroidal Perfusion Deficits at 1 year compared to Baseline
研究概览
简要总结
The investigators wish to better understand the role of the choriocapillaris (CC) in the formation and progression of non-exudative in age related macular degeneration (armd) by imaging the retinal pigment epithelium (rpe) and the choroidal microvasculature and by studying their inter-dependence to determine if the loss of the CC could prove useful as an anatomic clinical trial endpoint in future drug trials.
详细描述
This is a longitudinal observational study where the investigators will look at 450 subjects, 200 with intermediate AMD in at least one eye, or with AMD in one eye, either early or intermediate, and with late AMD (exudative) in the other eye, and 250 subjects with nGA or GA in at least one eye.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Aged 50 and over
- •Clinic diagnosis of non-exudative iAMD in at least one eye with a drusen volume in the central 3 mm circle centered on the fovea of at least 0.02 mm3 in the absence of GA or nGA as diagnosed with OCT en face imaging OR Clinical diagnosis of early or early/intermediate stage AMD in one eye in the absence of nGA or GA and exudative AMD in the other eye OR clinical diagnosis of GA or nGA secondary to AMD that is at least the size of a large druse (125 microns in diameter; 0.05 mm2) and no greater than 7 disc areas (17 mm2) in at least one eye which has never been treated with anti-VEGF agents
- •Willing and able to comply with clinic visits and study-related procedures
- •Provide signed informed consent
排除标准
- •A subject who meets any of the following criteria will be excluded from the study:
- •Below the age of 50
- •Subjects with exudative AMD in both eyes
- •Eyes with evidence of non-proliferative and proliferative diabetic retinopathy.
- •Presence of confounding ocular diagnosis such as myopia >6D, or other ocular conditions that may cause retinal pigment epithelium atrophy or exudative MNV
- •Subjects unable to give informed consent.
- •Subjects who are unable to comply with imaging guidelines
结局指标
主要结局
Change in Choroidal Perfusion Deficits at 1 year compared to Baseline
时间窗: 1 year time point
Assessment of Choriocapillaris perfusion
次要结局
- Pre-existing sub-clinical Macular Neovascularization (MNV)(1 year and 2-year time points)
- Automated Drusen Volume measurements(1 year and 2-year time points)
- Structural OCT markers and Genetic Markers(1 year and 2-year time points)
- Automated GA measurements(1 year and 2-year time points)