Back to resultsBioCurrent 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Withdrawn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
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
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
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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