NCT02699216|Withdrawn
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Sponsor study identifier
interventional
0
0 countries
N/A
Study Start
January 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2016
Date type not reportedThis date has not been verified as actual or estimated.
February 16, 2016
Actual (reported)March 4, 2016
Actual (reported)October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Changes in retinal sensitivity assessed by Microperimetry
Baseline, Day 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.
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.
Transpalpebral micro-current electrical stimulation treatment for 3 consecutive days followed by a short wash-out period of 2 days.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
0 participants (actual enrollment reported by the registry).
First Submitted
February 16, 2016
First Posted
March 4, 2016
Study Start
January 2016
Date type not reportedThis date has not been verified as actual or estimated.
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.
Contact the study team to confirm eligibility.
Primary Completion
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 6, 2018
Record last verified: 2018-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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