NCT05703867

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of transpalpebral microcurrent stimulation as a therapy for dry age-related macular degeneration. Participants are assessed at baseline for visual acuity and treated for 4 consecutive days for a total of 8 sessions (2 per day) with microcurrent stimulation. A follow-up visit is conducted to evaluate the participant and collect follow-up visual acuity.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
404

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 1998

Status
completed

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, 1998

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 1999

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1999

Completed
23.2 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

1.9 years

First QC Date

January 20, 2023

Last Update Submit

January 28, 2023

Conditions

Age-Related Macular DegenerationNonexudative Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Mean logMAR BCVA

    Mean logarithm of the minimum angle of resolution (logMAR) best-corrected visual acuity (BCVA) following the last treatment

    Week 1

Secondary Outcomes (1)

  • Proportion of improved, stable or worsened BCVA

    Week 1

Study Arms (1)

Active microcurrent therapy

EXPERIMENTAL
Device: Active microcurrent therapy

Interventions

Active microcurrent therapyDEVICE

Non-invasive transpalpebral microcurrent therapy delivery to the upper and lower eyelids

Active microcurrent therapy

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged at least 50 years with dry AMD in at least one eye

You may not qualify if:

  • Eye diseases other than dry AMD
  • Implanted electrical devices
  • Seizure disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2023

First Posted

January 30, 2023

Study Start

January 1, 1998

Primary Completion

December 1, 1999

Study Completion

December 1, 1999

Last Updated

January 31, 2023

Record last verified: 2023-01