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

i-Lumen Scientific, Inc.95 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Interventions

i-Lumen(TM) AMDDEVICE

Transpalpebral microcrurrent stimulation

i-Lumen(TM) AMD ShamDEVICE

Transpalpebral sham stimulation

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (10)

Associated Retina Consultants

Phoenix, Arizona, United States

Bay Area Retina Associates

Walnut Creek, California, United States

University Retina and Macula Associates, PC

Lemont, Illinois, United States

Outcomes

Primary Outcomes

Adverse Device Effects

Incidence of device- and/or treatment-related serious adverse events (SAEs) and/or serious adverse device effects (SADE) at any point during the study

Time frame: Through study completion, Month 12 timepoint

Data from ClinicalTrials.gov

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