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BioCurrent Electrical Stimulation for the Treatment of Dry ARMD

Primary Purpose

Dry Macular Degeneration

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Electrical Stimulation of the Retina
Sponsored by
DuBois Vision Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

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

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    Arm Type

    Experimental

    Placebo Comparator

    Experimental

    Arm Label

    Phase 1 Active Treatment

    Phase 1 Sham Treatment

    Phase 2 Open Label

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Changes in retinal sensitivity assessed by Microperimetry
    Significant Changes in retinal sensitivity; baseline and Day 5.

    Full Information

    First Posted
    February 16, 2016
    Last Updated
    June 2, 2018
    Sponsor
    DuBois Vision Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02699216
    Brief Title
    BioCurrent Electrical Stimulation for the Treatment of Dry ARMD
    Official Title
    BioCurrent Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    October 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    DuBois Vision Clinic

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dry Macular Degeneration
    Keywords
    Macular Degeneration, Eye Diseases, Retinal Degeneration, Retinal Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Phase 1 Active Treatment
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Phase 1 Sham Treatment
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Arm Title
    Phase 2 Open Label
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Electrical Stimulation of the Retina
    Intervention Description
    Transpalpebral micro-current electrical stimulation treatment for 3 consecutive days followed by a short wash-out period of 2 days.
    Primary Outcome Measure Information:
    Title
    Change in Best-corrected Visual Acuity using the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
    Description
    Significant changes in ETDRS visual acuity; baseline and Day 5.
    Time Frame
    Baseline, Day 5
    Secondary Outcome Measure Information:
    Title
    Changes in retinal sensitivity assessed by Microperimetry
    Description
    Significant Changes in retinal sensitivity; baseline and Day 5.
    Time Frame
    Baseline, Day 5

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    BioCurrent Electrical Stimulation for the Treatment of Dry ARMD

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