Erythrocyte Ghost Mediated Retinal Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Capillary erythrocyte movement
研究概览
简要总结
Instead of the usual procedure of injecting ICG dye directly into an arm vein, now the dye can be placed inside of RBCs. When a small volume of the RBC's with the dye is injected into a person's arm, the individual RBCs can be seen as they flow through the retinal blood vessels.
详细描述
Capillary erythrocyte movement throughout the entire human macula can be observed routinely for periods up to 20 minutes by autologous re-injection of a small volume (about 1 mL) of indocyanine green (ICG)-loaded erythrocytes, making possible for the first time quantification of blood flow in individual capillaries, including abnormal structures like choroidal neovascularization (CNV), and it makes possible characterization of vasomotion in ocular vasculatures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female, of any race who is at least 40 years of age and has clinical signs of CNV or exudative manifestations of AMD, has clinical signs of DR, or clinical signs of retinal occlusive disease.
- •Patients with subfoveal, extrafoveal or juxtafoveal CNV, which is classic, minimally classic or occult and has dimensions less than 25.0 mm2 as measured on the sodium fluorescein angiogram (SFA).
- •Patient with recurrent CNV, where previous treatment never involved the foveal avascular zone (FAZ).
- •Analysis of highspeed ICGA must show one or more welldefined feeder vessel.
- •Patient must have best corrected visual acuity based on the ETDRS chart between 20/40 and 20/320 in the study eye.
- •Patient must be willing, be able to comply with the protocol and provide informed consent.
排除标准
- •CNV secondary to any cause other than AMD or DR.
- •Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
- •Patient participating in any other investigational drug study.
- •Patient with significant liver disease or uremia.
- •Patient with known adverse reaction to indocyanine green or iodine.
- •Patient is pregnant or nursing.
结局指标
主要结局
Capillary erythrocyte movement
时间窗: 1 hour
To demonstrate in each subject eye the differences between erythrocyte movement through retinal and choroidal capillaries in normal fundus areas and their movement through abnormal areas associated with vascular disease
次要结局
- Retinal capillary movement(1 hour)