Safety and Clinical Applicability of Transcorneal Electrical Stimulation (TES) in Geographic Atrophy Under Everyday Conditions - a Multicentric, Randomized, Double-masked, Sham-controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 6
- 主要终点
- Safety of TES therapy in GA
研究概览
简要总结
Geographic atrophy (GA) is a progressive eye disease that causes the degeneration of the retinal cells, particularly in the macula, leading to vision loss. The goal of this pilot study is to evaluate the safety and the effectiveness of transcorneal electrical stimulation (TES) therapy with the OkuStim 2 System in patients with geographic atrophy (GA).
Researchers will compare the effects of two different electrical stimuli with a placebo to see if the stimuli are safe and can slow down the progression of the disease.
Participants will be randomly assigned to one of these three groups:
- TES-treatment with a rectangular stimulus
- TES-treatment with a repetitive ramp stimulus
- Placebo (sham) treatment
Participants will apply the therapy at home, once a week for 30 minutes each over a duration of 1 year.
详细描述
Geographic atrophy (GA) is a progressive eye disease that causes the degeneration of the retinal cells, particularly in the macula, leading to vision loss. Currently, there is no approved therapy specifically for GA in Europe.
The aim of this pilot study is to evaluate the safety and potential efficacy of the treatment of visual field defects in patients with GA using transcorneal electrical stimulation (TES) with the OkuStim 2 System. One of the main mechanisms for the loss of retinal cells in GA is inflammation. It is known from preclinical studies that electrical stimulation of the eye can inhibit inflammation or cellular reactions to inflammatory processes in the retina, trigger neuroprotective mechanisms and promote blood flow in the retina. The multicentric, randomized, double-masked, sham-controlled pilot study is based on the assumption that these mechanisms can maintain the functional integrity of the outer zone of the lesion area for longer.
Participants will be randomly assigned 1:1:1 to one of these three groups:
- TES-treatment with a rectangular stimulus
- TES-treatment with a repetitive ramp stimulus
- Placebo (sham) treatment
After an initial training phase, participants will apply the therapy at home, once a week for 30 minutes each over a duration of 1 year. Only one eye will be treated (study eye).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The patient is masked to the treatment group he or she has been assigned to. The programming of the stimulation parameters on the OkuStim 2 is carried out by unmasked members of the study team as it is impossible to program the OkuStim 2 without knowing the assignment of the patient to the study group. Examinations relating to the primary, secondary or exploratory endpoints are carried out only by masked team members.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to understand the study and provide informed consent
- •60 years of age or older
- •Diagnosis of geographic atrophy due to age-related macular degeneration confirmed by imaging
- •The affected area in the eye must be within a defined size range and clearly visible on imaging
- •Eye conditions must allow for good-quality images and reliable measurements
- •Must have a minimum level of visual acuity
- •Women of childbearing potential must have a negative pregnancy test, and must agree to use effective contraception during the study (women who are postmenopausal or surgically sterile are not subject to pregnancy-related requirements)
排除标准
- •History or presence of certain eye conditions (e.g. macular edema, abnormal blood vessel growth or related conditions, retinal detachment, blood vessel blockage) in the study eye
- •Previous major eye surgeries (including retinal surgery or vitrectomy)
- •Previous laser treatment or injections in the study eye
- •Any other eye condition that could interfere with vision tests, imaging or study results
- •Planned eye surgery during the study period
- •Recent treatment with investigational drugs for geographic atrophy
- •Presence of active medical implants
- •Serious or uncontrolled systemic diseases, history of epilepsy or poor general health or conditions affecting the ability to follow study procedures
- •Participation in another clinical study recently or at the same time
- •Breastfeeding, relevant allergies (e.g. to silver), or heavy smoking
研究组 & 干预措施
Sham group
The stimulation in the sham-group will be carried out with 0µA. Sham-stimulation will be performed once per week, for 30 minutes, for 12 months
干预措施: Transcorneal electrical stimulation (TES) with the OkuStim 2 System (Device)
TES-treatment with a rectangular stimulus
A ramp is applied in the beginning of the stimulation to avoid that the patient is startled by the onset of stimulation: 0µA to therapy amplitude, ramping up in 30 seconds. The therapy amplitude is then maintained for 30 minutes. The stimulation parameters are: symmetric biphasic rectangular pulse (anodic at first) with a frequency of 20 Hz and a pulse duration of 10ms (5ms each phase). Stimulation will be performed once per week, for 30 minutes, for 12 months.
干预措施: Transcorneal electrical stimulation (TES) with the OkuStim 2 System (Device)
TES-treatment with a repetitive ramp stimulus
A ramp is applied in the beginning of the stimulation to avoid that the patient is startled by the onset of stimulation: 0µA to therapy amplitude, ramping up in 30 seconds. The therapy amplitude is then maintained for 30 minutes. The stimulation parameters are: ramp-down sawtooth current pulses (anodic first) with a frequency of 20 Hz. Stimulation will be performed once per week, for 30 minutes, for 12 months.
干预措施: Transcorneal electrical stimulation (TES) with the OkuStim 2 System (Device)
结局指标
主要结局
Safety of TES therapy in GA
时间窗: From enrolment until the end of the study for the individual participant at 52 weeks
Determined by the nature and number of device-related adverse events
次要结局
- Effects of TES therapy with two different stimulus waveforms on the progression of GA lesion areas(At 12 months and at timepoints in between (4, 17 and 34 weeks after the baseline-visit) compared to baseline)
- Effects of TES therapy with two different stimulus waveforms on structural changes in retinal layers(At 12 months and at timepoints in between (4, 17 and 34 weeks after the baseline-visit) compared to baseline)
- Effects of TES therapy with two different stimulus waveforms on functional changes in the border zone of GA areas(At 12 months and at timepoints in between (17 and 34 weeks after the baseline-visit) compared to baseline)
- Effects of TES therapy with two different stimulus waveforms on visual acuity under normal luminance conditions(At 12 months and at timepoints in between (4, 17 and 34 weeks after the baseline-visit) compared to baseline)
- Effects of TES therapy with two different stimulus waveforms on visual acuity under low-luminance conditions(At 12 months and at timepoints in between (4, 17 and 34 weeks after the baseline-visit) compared to baseline)
- Effects of TES therapy with two different stimulus waveforms on patient-reported outcomes regarding the impact on daily life(At 12 months compared to baseline)
- Effects of TES therapy with two different stimulus waveforms on patient-reported outcome regarding the applicability of the therapy under everyday conditions during home-use(At 12 months compared to baseline)