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

January 2, 2024 updated by: i-Lumen Scientific, Inc.

Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT): A Multicenter, Randomized, Sham-controlled, Feasibility Device Trial.

Evaluate the safety and efficacy of transpalpebral microcurrent stimulation (MCS) therapy for patients with nonexudative (dry) age-related macular degeneration (AMD).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The i-Lumen(TM) AMD device is for in-office therapy use to deliver microcurrent electrical stimulation transpalpebrally (via the eyelid) for use by an ophthalmologist. The i-Lumen AMD device contains proprietary software with preset treatment algorithms and is calibrated at each session to the individual participant.

Up to 30 enrolled participants will be randomized (2:1 active to sham ratio) and complete the initial 5-day loading treatment sessions. Participants completing the initial loading sessions will receive two (2) days of maintenance treatments and be following and be followed through the one (1) year time point.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • Active, not recruiting
        • Associated Retina Consultants
    • California
      • Walnut Creek, California, United States, 94598
        • Recruiting
        • Bay Area Retina Associates
        • Contact:
        • Principal Investigator:
          • Caesar Luo, MD
    • Illinois
      • Lemont, Illinois, United States, 60439
        • Recruiting
        • University Retina and Macula Associates, PC
        • Principal Investigator:
          • Veeral Sheth, MD
        • Contact:
    • Pennsylvania
      • Chambersburg, Pennsylvania, United States, 21740
        • Completed
        • Cumberland Valley Retina Consultants
      • Erie, Pennsylvania, United States, 16507
        • Recruiting
        • Erie Retina Research, LLC
        • Contact:
        • Principal Investigator:
          • David Almeida, MD, PHD
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • Charles Retina Institute
        • Contact:
        • Principal Investigator:
          • Stephen Huddleston, MD
        • Contact:
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Austin Research Center for Retina
        • Principal Investigator:
          • Saradha Chexal, MD
        • Contact:
      • Bellaire, Texas, United States, 77401
      • Burleson, Texas, United States, 76028
        • Recruiting
        • Star Retina
        • Principal Investigator:
          • Courtney Crawford, MD
        • Contact:
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Texas Retina Associates
        • Contact:
        • Principal Investigator:
          • Partrick Williams, MD

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

Description

Key Inclusion Criteria:

  • Age ≥50 years.
  • Non-exudative age-related macular degeneration defined as AREDS category 3 Intermediate AMD and/or geographic atrophy
  • Best-corrected distance visual acuity 20/40 to 20/200 (inclusive) in the study eye, and BCVA 20/100 or better in the fellow eye

Key Exclusion Criteria:

  • History and/or evidence of exudative age-related macular degeneration in either eye
  • History and/or evidence of diabetic retinopathy in either eye
  • Current tobacco or tobacco-related product use or history within the past 10 years of heavy smoking (on average, more than half a pack of cigarettes per day)
  • Central chorioretinal atrophy in the study eye
  • Glaucoma in the study eye

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: i-Lumen AMD Active
Active transpalpebral microcurrent stimulation therapy
Device: i-Lumen(TM) AMD
Transpalpebral microcrurrent stimulation
Sham Comparator: i-Lumen AMD Sham
Sham transpalpebral microcurrent stimulation therapy
Device: i-Lumen(TM) AMD Sham
Transpalpebral sham stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Device Effects
Time Frame: Through study completion, Month 12 timepoint
Incidence of device- and/or treatment-related serious adverse events (SAEs) and/or serious adverse device effects (SADE) at any point during the study
Through study completion, Month 12 timepoint

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change best corrected distance visual acuity
Time Frame: Through Month 12 timepoint
Mean change from baseline of best corrected distance visual acuity (CDVA) letter score
Through Month 12 timepoint

Collaborators and Investigators

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

Sponsor

i-Lumen Scientific, Inc.

Investigators

  • Study Director: Meredith Mundy, i-Lumen Scientific, Inc.

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 (Actual)

April 12, 2022

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

June 29, 2022

First Submitted That Met QC Criteria

July 1, 2022

First Posted (Actual)

July 7, 2022

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILS-AMD-201

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

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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