BioCurrent Electrical Stimulation for the Treatment of Dry ARMD

NCT ID: NCT02699216

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-12-31

Brief Summary

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

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.

Conditions

Dry Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Electrical Stimulation of the Retina

Intervention Type: DEVICE

Transpalpebral micro-current electrical stimulation treatment for 3 consecutive days followed by a short wash-out period of 2 days.

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.

Group Type: PLACEBO_COMPARATOR

Electrical Stimulation of the Retina

Intervention Type: DEVICE

Transpalpebral micro-current electrical stimulation treatment for 3 consecutive days followed by a short wash-out period of 2 days.

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.

Group Type: EXPERIMENTAL

Electrical Stimulation of the Retina

Intervention Type: DEVICE

Transpalpebral micro-current electrical stimulation treatment for 3 consecutive days followed by a short wash-out period of 2 days.

Interventions

Electrical Stimulation of the Retina

Transpalpebral micro-current electrical stimulation treatment for 3 consecutive days followed by a short wash-out period of 2 days.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

DuBois Vision Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

WSW001

Identifier Type: -

Identifier Source: org_study_id