BioCurrent Electrical Stimulation for the Treatment of Dry ARMD

June 2, 2018 updated by: DuBois Vision Clinic

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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
Time Frame: Baseline, Day 5
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
Time Frame: Baseline, Day 5
Significant Changes in retinal sensitivity; baseline and Day 5.
Baseline, Day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DuBois Vision Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

February 16, 2016

First Submitted That Met QC Criteria

March 1, 2016

First Posted (Estimate)

March 4, 2016

Study Record Updates

Last Update Posted (Actual)

June 6, 2018

Last Update Submitted That Met QC Criteria

June 2, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WSW001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dry Macular Degeneration

Clinical Trials on Electrical Stimulation of the Retina

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe