BioCurrent Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Change in Best-corrected Visual Acuity using the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
研究概览
简要总结
This study evaluates the treatment of Dry Macular Degeneration and the resulting change in vision with a very, very low current that is similar to what occurs in the body naturally. In Phase 1, 16 participants will be treated, with half receiving treatment and half a sham (no treatment). After the treatment period of one week, those not treated will be treated. In Phase 2, all participants will be treated.
详细描述
The study will assess the effectiveness of transpalpebral micro-current electrical stimulation on improving the visual acuity in subjects with vision loss from Dry Macular Degeneration. The BioCurrent electrical stimulation will be applied by a device with the intended use of treating Dry Macular Degeneration. The device delivers a micro-current, an electrical current in the one millionth of an ampere range, to the retina in frequencies changing in a pre-defined pattern from 5Hz to 80Hz during each spot (40 sec). The device also incorporates a voltage limiter (a maximum of 245 micro A is possible) and a current level indicator. 200 micro A will be used. Very low electrical micro-current is delivered to the subject through the goggle probe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Best-corrected visual acuity can be no better than 20/40 and no worse than 20/200 for each enrolled eye
- •Confirmed diagnosis of Dry MD
- •Vision loss attributable to Dry MD
- •Subjects must be highly motivated, alert, oriented, mentally competent and able to understand and comply with the requirements of the study, abide by the restrictions, return for all required visits, and provide voluntary informed consent
排除标准
- •Any retinal pathology other than Dry MD
- •Evidence or history of wet MD
- •Previous intravitreal injection
- •Seizure disorders
- •Dense cataract
- •Eyelid pathology at the treatment sites
- •Any prior electrical micro-stimulation treatment to the eyes
- •Poor general health
- •Active cancer
- •Life expectancy less than 12 months
- •Non-ambulatory
- •Not considered suitable for participation for any other reason
研究组 & 干预措施
Phase 1 Active Treatment
Subjects will undergo 8 treatments, approximately 11 minutes, to the enrolled eyes daily for three consecutive days, with an active device. They will receive no treatments on day 4 and 5.
干预措施: Electrical Stimulation of the Retina (Device)
Phase 1 Sham Treatment
Subjects will undergo 8 sham treatments, approximately 11 minutes, with a non-functional device to the enrolled eyes daily for three consecutive days during week 1, with no treatments on day 4 and 5. Followed by 8 active treatments, for approximately 11 minutes, for three consecutive days, with an active device during week 2, with no treatments on day 4 and 5.
干预措施: Electrical Stimulation of the Retina (Device)
Phase 2 Open Label
Subjects will undergo 8 treatments, approximately 11 minutes, to the enrolled eyes daily for three consecutive days, with an active device. They will receive no treatments on day 4 and 5.
干预措施: Electrical Stimulation of the Retina (Device)
结局指标
主要结局
Change in Best-corrected Visual Acuity using the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
时间窗: Baseline, Day 5
Significant changes in ETDRS visual acuity; baseline and Day 5.
次要结局
- Changes in retinal sensitivity assessed by Microperimetry(Baseline, Day 5)