BioCurrent Electrical Stimulation for the Treatment of Dry ARMD

Dry Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02699216
• Other study ID #: WSW001
• Status: Withdrawn
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: June 2018
• Source: DuBois Vision Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Macular Degeneration
• Geographic Atrophy
• Macular Degeneration

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
DuBois Vision Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in retinal sensitivity assessed by Microperimetry	Significant Changes in retinal sensitivity; baseline and Day 5.	Baseline, Day 5