Age-Related Macular Degeneration, Dry Age-related Macular Degeneration, Nonexudative Age-related Macular Degeneration
Conditions
Keywords
AMD, Dry AMD
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.
Interventions
DEVICEi-Lumen(TM) AMD
Transpalpebral microcrurrent stimulation
DEVICEi-Lumen(TM) AMD Sham
Transpalpebral sham stimulation
Sponsors
i-Lumen Scientific, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean change best corrected distance visual acuity | Through Month 12 timepoint | Mean change from baseline of best corrected distance visual acuity (CDVA) letter score |
Countries
United States
Outcome results
None listed