Age-Related Macular Degeneration Clinical Trial
— i-SIGHTOfficial title:
Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT): A Multicenter, Randomized, Sham-controlled, Feasibility Device Trial.
| NCT number | NCT05447650 |
| Other study ID # | ILS-AMD-201 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 12, 2022 |
| Est. completion date | March 2024 |
Evaluate the safety and efficacy of transpalpebral microcurrent stimulation (MCS) therapy for patients with nonexudative (dry) age-related macular degeneration (AMD).
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| i-Lumen Scientific, Inc. |
United States,
| 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 |
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