BioCurrent Electrical Stimulation for the Treatment of Dry ARMD

• ClinicalTrials.gov Identifier: NCT02699216
• Recruitment Status: Withdrawn
• First Posted: March 4, 2016
• Last Update Posted: June 6, 2018
• Sponsor: DuBois Vision Clinic
• Information provided by (Responsible Party): DuBois Vision Clinic

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Dry Macular Degeneration	Device: Electrical Stimulation of the Retina	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: BioCurrent Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration
• Study Start Date: January 2016
• Estimated Primary Completion Date: October 2017
• Estimated Study Completion Date: December 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Device: 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.
Placebo Comparator: 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.	Device: 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.
Experimental: 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.	Device: 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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Changes in retinal sensitivity assessed by Microperimetry [ Time Frame: Baseline, Day 5 ]
   Significant Changes in retinal sensitivity; baseline and Day 5.

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: DuBois Vision Clinic
• ClinicalTrials.gov Identifier: NCT02699216
• Other Study ID Numbers: WSW001
• First Posted: March 4, 2016
• Last Update Posted: June 6, 2018
• Last Verified: June 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by DuBois Vision Clinic:

Macular Degeneration; Eye Diseases; Retinal Degeneration; Retinal Diseases

Additional relevant MeSH terms:

Macular Degeneration; Geographic Atrophy; Retinal Degeneration; Retinal Diseases; Eye Diseases