NCT04511936

Brief Summary

Evaluate the safety and efficacy of microcurrent stimulation therapy for patients with dry age-related macular degeneration.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

11 months

First QC Date

August 11, 2020

Last Update Submit

April 6, 2021

Conditions

Dry Age-related Macular Degeneration

Keywords

AMDDry AMD

Outcome Measures

Primary Outcomes (1)

  • Mean change from baseline in best-corrected distance visual acuity (CDVA) at one month timepoint.

    1 Month

Secondary Outcomes (1)

  • Best-corrected distance visual acuity (CDVA) response rate at 1 month visit.

    1 Month

Study Arms (2)

i-Lumen AMD Active

ACTIVE COMPARATOR
Device: i-Lumen AMD

i-Lumen AMD Sham

SHAM COMPARATOR
Device: i-Lumen AMD Sham

Interventions

i-Lumen AMDDEVICE

Microcurrent stimulator

i-Lumen AMD Active
i-Lumen AMD ShamDEVICE

Sham microcurrent stimulator

i-Lumen AMD Sham

Eligibility Criteria

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

You may qualify if:

  • Dry AMD diagnosis.

You may not qualify if:

  • Wet AMD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Timothy Jackson, MD

    King's College London

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2020

First Posted

August 13, 2020

Study Start

March 1, 2021

Primary Completion

January 31, 2022

Study Completion

January 31, 2023

Last Updated

April 8, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share