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

Age-Related Macular Degeneration Clinical Trial

— i-SIGHT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05447650
• Other study ID #: ILS-AMD-201
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2022
• Est. completion date: March 2024

Study information

• Verified date: January 2024
• Source: i-Lumen Scientific, Inc.
• Contact: Meredith Mundy
• Phone: 408-440-7049
• Email: clinical[@]i-lumen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Dry Age-related Macular Degeneration
• Geographic Atrophy
• Macular Degeneration
• Nonexudative Age-related Macular Degeneration

Intervention

Device:
• i-Lumen(TM) AMD
Transpalpebral microcrurrent stimulation
• i-Lumen(TM) AMD Sham
Transpalpebral sham stimulation

Locations

Country	Name	City	State
United States	Austin Research Center for Retina	Austin	Texas
United States	Retina Consultants of Texas	Bellaire	Texas
United States	Star Retina	Burleson	Texas
United States	Cumberland Valley Retina Consultants	Chambersburg	Pennsylvania
United States	Erie Retina Research, LLC	Erie	Pennsylvania
United States	Texas Retina Associates	Fort Worth	Texas
United States	Charles Retina Institute	Germantown	Tennessee
United States	University Retina and Macula Associates, PC	Lemont	Illinois
United States	Associated Retina Consultants	Phoenix	Arizona
United States	Bay Area Retina Associates	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
i-Lumen Scientific, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean change best corrected distance visual acuity	Mean change from baseline of best corrected distance visual acuity (CDVA) letter score	Through Month 12 timepoint
Primary	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