Non Exudative Age-Related Macular Degeneration Imaged With Swept Source Optical Coherence Tomography: The Extension Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 5
- 主要终点
- Change in the Percentage of 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
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. This is an extension of a currently ongoing longitudinal observational study (BIRC-01) (NCT03688243).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrollment in and completion of the BIRC-01 study
- •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
- •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 currently or previously enrolled in other interventional clinical trials in which treatment was administered to the study eye.
- •Previous vitrectomy or intravitreal injections in the study eye.
- •Axial length measurement ≥ 26 mm.
- •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 the Percentage of Choroidal Perfusion Deficits at 1 year compared to Baseline
时间窗: 1-year and 2-year time points
Compare the percentage of choroidal perfusion deficits as measured using automated algorithms
次要结局
- Pre-existing and new sub-clinical Macular Neovascularization (MNV)(1-year and 2-year time points)
- Automated Geography Atrophy measurements(1-year and 2-year time points)
- Automated Drusen Volume measurements(1-year and 2-year time points)
- Choroidal Vascularity Index (percentage)(1-year and 2-year time points)
- Choroidal Thickness (millimeters)(1-year and 2-year time points)