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Completed

NCT Number: NCT05447650

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

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

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Key information

Conditions

Age-Related Macular Degeneration Dry Age-related Macular Degeneration Eye Diseases Macular Degeneration Nonexudative Age-related Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Associated Retina Consultants, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

i-Lumen(TM) AMD

Device

Transpalpebral microcrurrent stimulation

i-Lumen(TM) AMD Sham

Device

Transpalpebral sham stimulation

Primary outcomes

  1. 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

i-Lumen Scientific, Inc.

Industry

Registry information

Official study title

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

Acronym: i-SIGHT

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 7, 2022
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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