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

i-Lumen Scientific

Status: Active, not recruiting

Conditions: Age-Related Macular Degeneration; Nonexudative Age-related Macular Degeneration; Dry Age-related Macular Degeneration

Treatments: Device: i-Lumen(TM) AMD; Device: i-Lumen(TM) AMD Sham

Study type: Interventional

Funder types: Industry

Identifiers

NCT05447650

ILS-AMD-201

Details and patient eligibility

About

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

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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95 participants in 2 patient groups

i-Lumen AMD Active

Experimental group

Description:

Active transpalpebral microcurrent stimulation therapy

Treatment:

Device: i-Lumen(TM) AMD

i-Lumen AMD Sham

Sham Comparator group

Description:

Sham transpalpebral microcurrent stimulation therapy

Treatment:

Device: i-Lumen(TM) AMD Sham