BioCurrent Electrical Stimulation for the Treatment of Dry ARMD
Dry Macular Degeneration
About this trial
This is an interventional treatment trial for Dry Macular Degeneration focused on measuring Macular Degeneration, Eye Diseases, Retinal Degeneration, Retinal Diseases
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Placebo Comparator
Experimental
Phase 1 Active Treatment
Phase 1 Sham Treatment
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.
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.
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.