BioCurrent Electrical Stimulation for the Treatment of Dry ARMD
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2016
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 16, 2016
CompletedFirst Posted
Study publicly available on registry
March 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJune 6, 2018
June 1, 2018
1.8 years
February 16, 2016
June 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline, Day 5
Secondary Outcomes (1)
Changes in retinal sensitivity assessed by Microperimetry
Baseline, Day 5
Study Arms (3)
Phase 1 Active Treatment
EXPERIMENTALSubjects 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.
Phase 1 Sham Treatment
PLACEBO COMPARATORSubjects 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.
Phase 2 Open Label
EXPERIMENTALSubjects 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.
Interventions
Transpalpebral micro-current electrical stimulation treatment for 3 consecutive days followed by a short wash-out period of 2 days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2016
First Posted
March 4, 2016
Study Start
January 1, 2016
Primary Completion
October 1, 2017
Study Completion
December 1, 2017
Last Updated
June 6, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share