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

Last updated: December 5, 2024
Sponsor: i-Lumen Scientific, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Macular Degeneration

Aging

Geographic Atrophy

Treatment

i-Lumen(TM) AMD Sham

i-Lumen(TM) AMD

Clinical Study ID

NCT05447650
ILS-AMD-201
  • Ages > 50
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Age ≥50 years.

  • Non-exudative age-related macular degeneration defined as AREDS category 3Intermediate 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

Exclusion

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 yearsof 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 Design

Total Participants: 95
Treatment Group(s): 2
Primary Treatment: i-Lumen(TM) AMD Sham
Phase:
Study Start date:
April 12, 2022
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Associated Retina Consultants

    Phoenix, Arizona 85020
    United States

    Site Not Available

  • Bay Area Retina Associates

    Walnut Creek, California 94598
    United States

    Site Not Available

  • University Retina and Macula Associates, PC

    Lemont, Illinois 60439
    United States

    Site Not Available

  • Cumberland Valley Retina Consultants

    Chambersburg, Pennsylvania 21740
    United States

    Site Not Available

  • Erie Retina Research, LLC

    Erie, Pennsylvania 16507
    United States

    Site Not Available

  • Charles Retina Institute

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Austin Research Center for Retina

    Austin, Texas 78705
    United States

    Site Not Available

  • Retina Consultants of Texas

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Star Retina

    Burleson, Texas 76028
    United States

    Site Not Available

  • Texas Retina Associates

    Fort Worth, Texas 76104
    United States

    Site Not Available

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