BioCurrent Electrical Stimulation for the Treatment of Dry ARMD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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BioCurrent Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration

Conditions
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Dry Macular Degeneration

Intervention / Treatment
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* Device: Electrical Stimulation of the Retina


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase 1 Active Treatment<br>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. | Device: Electrical Stimulation of the Retina<br>* Transpalpebral micro-current electrical stimulation treatment for 3 consecutive days followed by a short wash-out period of 2 days.<br>|
| Placebo Comparator: Phase 1 Sham Treatment<br>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. | Device: Electrical Stimulation of the Retina<br>* Transpalpebral micro-current electrical stimulation treatment for 3 consecutive days followed by a short wash-out period of 2 days.<br>|
| Experimental: Phase 2 Open Label<br>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. | Device: Electrical Stimulation of the Retina<br>* Transpalpebral micro-current electrical stimulation treatment for 3 consecutive days followed by a short wash-out period of 2 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Best-corrected Visual Acuity using the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart | Significant changes in ETDRS visual acuity; baseline and Day 5. | Baseline, Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in retinal sensitivity assessed by Microperimetry | Significant Changes in retinal sensitivity; baseline and Day 5. | Baseline, Day 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Macular Degeneration, Eye Diseases, Retinal Degeneration, Retinal Diseases