Clinical trial NCT05447650: Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT)
Official title: Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT): a Multicenter, Randomized, Sham-controlled, Feasibility Device Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Age-Related Macular Degeneration
Dry Age-related Macular Degeneration
Nonexudative Age-related Macular Degeneration
Keywords: AMD
Dry AMD
Lead sponsor: i-Lumen Scientific, Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-07
Enrollment: 95
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Adverse Device Effects
timeFrame: Through study completion, Month 12 timepoint
Secondary outcomes:
Other outcomes:
measure: Mean change best corrected distance visual acuity
timeFrame: Through Month 12 timepoint
Locations:
city: Phoenix
country: United States
facility: Associated Retina Consultants
state: Arizona
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates
state: California
city: Lemont
country: United States
facility: University Retina and Macula Associates, PC
state: Illinois
city: Chambersburg
country: United States
facility: Cumberland Valley Retina Consultants
state: Pennsylvania
city: Erie
country: United States
facility: Erie Retina Research, LLC
state: Pennsylvania
city: Germantown
country: United States
facility: Charles Retina Institute
state: Tennessee
city: Austin
country: United States
facility: Austin Research Center for Retina
state: Texas
city: Bellaire
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Burleson
country: United States
facility: Star Retina
state: Texas
city: Fort Worth
country: United States
facility: Texas Retina Associates
state: Texas
Study officials:
affiliation: i-Lumen Scientific, Inc.
name: Meredith Mundy
role: STUDY_DIRECTOR
References: