Microcurrent Stimulation for Dry Age-related Macular Dege... | NCT04511936

Studies
Microcurrent Stimulation for Dry Age-related Macular Degeneration

NCT04511936

Sponsor

i-Lumen Scientific, Inc.

Status

Withdrawn

Last Update Posted

Apr 8, 2021Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Dry Age-related Macular Degeneration

Interventions

i-Lumen AMD
i-Lumen AMD Sham

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

COVID-related delays.

Expanded Access Info

Start Date

Mar 1, 2021Estimated

Primary Completion Date

Jan 31, 2022Estimated

Completion Date

Jan 31, 2023Estimated

First Submitted Date

Aug 11, 2020

First Submission Date that Met QC Criteria

Aug 12, 2020

First Posted Date

Aug 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2021

Last Update Posted Date

Apr 8, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Multi-center, double-masked, randomized trial of microcurrent stimulation for the treatment of patients affected with dry age-related macular degeneration.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
i-Lumen AMD Active	Active Comparator		Device: i-Lumen AMD
i-Lumen AMD Sham	Sham Comparator		Device: i-Lumen AMD Sham

Interventions

Name	Type	Description	Arm Group Labels	Other Names
i-Lumen AMD	Device	Microcurrent stimulator	i-Lumen AMD Active
i-Lumen AMD Sham

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean change from baseline in best-corrected distance visual acuity (CDVA) at one month timepoint.		1 Month

Secondary Outcomes

Measure	Description	Time Frame
Best-corrected distance visual acuity (CDVA) response rate at 1 month visit.		1 Month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria - Study Eye:

Dry AMD diagnosis.

Key Exclusion Criteria - Study Eye:

Wet AMD

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Timothy Jackson, MD	King's College London	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided