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

Not Applicable

Active, not recruiting

• Conditions: Age-Related Macular Degeneration; Dry Age-related Macular Degeneration; Nonexudative Age-related Macular Degeneration
• Interventions: Device: i-Lumen(TM) AMD; Device: i-Lumen(TM) AMD Sham

• Registration Number: NCT05447650
• Lead Sponsor: i-Lumen Scientific, Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2022-04-12
• Study First Submitted: 2022-06-29
• Study First Submitted QC: 2022-07-01
• Study First Posted: 2022-07-07
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
i-Lumen AMD Active	i-Lumen(TM) AMD	Active transpalpebral microcurrent stimulation therapy
i-Lumen AMD Sham	i-Lumen(TM) AMD Sham	Sham transpalpebral microcurrent stimulation therapy

Primary Outcome Measures

Name	Time	Method
Adverse Device Effects	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

Trial Locations

Locations (10)

Associated Retina Consultants; 🇺🇸 Phoenix, Arizona, United States

Cumberland Valley Retina Consultants; 🇺🇸 Chambersburg, Pennsylvania, United States

University Retina and Macula Associates, PC; 🇺🇸 Lemont, Illinois, United States

Bay Area Retina Associates; 🇺🇸 Walnut Creek, California, United States

Star Retina; 🇺🇸 Burleson, Texas, United States

Erie Retina Research, LLC; 🇺🇸 Erie, Pennsylvania, United States

Charles Retina Institute; 🇺🇸 Germantown, Tennessee, United States

Retina Consultants of Texas; 🇺🇸 Bellaire, Texas, United States

Texas Retina Associates; 🇺🇸 Fort Worth, Texas, United States

Austin Research Center for Retina; 🇺🇸 Austin, Texas, United States