Microcurrent Stimulation for Dry Age-related Macular Degeneration (i-SIGHT)

April 6, 2021 updated by: i-Lumen Scientific, Inc.

Microcurrent Stimulation Therapy for Dry Age-related Macular Degeneration (i-SIGHT): a Multicenter, Randomized, Double-masked, Clinical Device Trial

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria - Study Eye:

  • Dry AMD diagnosis.

Key Exclusion Criteria - Study Eye:

  • Wet AMD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: i-Lumen AMD Active
Device: i-Lumen AMD
Microcurrent stimulator
Sham Comparator: i-Lumen AMD Sham
Device: i-Lumen AMD Sham
Sham microcurrent stimulator

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

i-Lumen Scientific, Inc.

Investigators

  • Principal Investigator: Timothy Jackson, MD, King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

January 31, 2022

Study Completion (Anticipated)

January 31, 2023

Study Registration Dates

First Submitted

August 11, 2020

First Submitted That Met QC Criteria

August 12, 2020

First Posted (Actual)

August 13, 2020

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILS-AMD-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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