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

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

Detailed Description
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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.

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

Conditions
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Nonexudative Age-related Macular Degeneration, Age-Related Macular Degeneration, Dry Age-related Macular Degeneration

Intervention / Treatment
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* Device: i-Lumen(TM) AMD
* Device: i-Lumen(TM) AMD Sham


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Through study completion, Month 12 timepoint | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMD, Dry AMD