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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| i-Lumen AMD Active | Experimental | Active transpalpebral microcurrent stimulation therapy |
|
| i-Lumen AMD Sham | Sham Comparator | Sham transpalpebral microcurrent stimulation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| i-Lumen(TM) AMD | Device | Transpalpebral microcrurrent stimulation |
| |
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean change best corrected distance visual acuity | Mean change from baseline of best corrected distance visual acuity (CDVA) letter score | Through Month 12 timepoint |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meredith Mundy | i-Lumen Scientific, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associated Retina Consultants | Phoenix | Arizona | 85020 | United States | ||
| Bay Area Retina Associates |
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| i-Lumen(TM) AMD Sham |
| Device |
Transpalpebral sham stimulation |
|
| Walnut Creek |
| California |
| 94598 |
| United States |
| University Retina and Macula Associates, PC | Lemont | Illinois | 60439 | United States |
| Cumberland Valley Retina Consultants | Chambersburg | Pennsylvania | 21740 | United States |
| Erie Retina Research, LLC | Erie | Pennsylvania | 16507 | United States |
| Charles Retina Institute | Germantown | Tennessee | 38138 | United States |
| Austin Research Center for Retina | Austin | Texas | 78705 | United States |
| Retina Consultants of Texas | Bellaire | Texas | 77401 | United States |
| Star Retina | Burleson | Texas | 76028 | United States |
| Texas Retina Associates | Fort Worth | Texas | 76104 | United States |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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