An Objective Study to Evaluate the Ability of Photobiomodulation to Improve Electroretinogram Outcomes in Subjects With Dry Age-Related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- ERG function
研究概览
简要总结
To evaluate the ability of Photobiomodulation (PBM) treatment using the Valeda® Light Delivery System to improve Electroretinogram (ERG) outcomes in subjects with dry Age-related Macular Degeneration (AMD).
详细描述
This study is an open label, prospective pilot study to evaluate retinal function after PBM treatment in eyes with dry AMD using ERG. The target enrollment is 15 subjects in up to two sites in the US. All subjects will receive PBM Treatment.
Subjects will receive three PBM treatments per week for three weeks for a total of nine sessions over 3 weeks.
The primary analysis will examine multi-focal ERG function changes from baseline to Month 1. Secondary analyses will examine multi-focal ERG function change from baseline to Month 3 and 6. Other endpoints will include other functions of ERG, ETDRS Visual Acuity, Contrast Sensitivity, Perimetry, Color Vision test and the Amsler grid test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female at least 50 years of age at Screening visit
- •ETDRS BCVA letter score of between 50* and 75* (Snellen equivalent of 20/100 to 20/32)
- •Diagnosis of dry AMD
- •Able to communicate well with the Investigator and able to understand and comply with the requirements of the study
- •Informed of the nature of this study and has provided written, informed consent in accordance with institutional, local and national regulatory guidelines
排除标准
- •Current or history of neovascular maculopathy
- •Presence of center involving GA within the central ETDRS 1 mm diameter at Screening
- •Media opacities, including cataracts, which might interfere with visual acuity or imaging in the study eye(s)
- •Posterior capsule opacification, which might interfere with visual acuity or imaging in the study eye(s)
- •Invasive eye surgery (e.g. cataract, capsulotomy) on a qualifying eye within three 3 months prior to Screening
- •Visually significant disease in any ocular structure apart from dry AMD
- •Serious medical illness that will prevent the subject from performing study activities
- •Presence of or history of malignancy within the past 5 years
- •Presence or history of known light sensitivity to yellow light, red light, or near infrared radiation (NIR), or if they have a history of light activated CNS disorders (e.g. epilepsy, migraine)
- •History of neurologic condition known to affect visual function
- •History of drug, alcohol or substance abuse within 3 months prior to Screening
- •Participation in any other clinical study at time of screening, or has received an investigational drug or treatment with an investigational device within 3 months prior to Screening
- •In the opinion of the Investigator, is unlikely to comply with the study protocol
结局指标
主要结局
ERG function
时间窗: 3 months
ERG assessments (Multifocal ERG (mfERG), Photopic Negative Response (PhNR), Multi-luminance Flicker ERG (ML-FERG) and Fixed-luminance Flicker ERG (FL-FERG)) will provide an output of retinal function.
次要结局
未报告次要终点