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

Sponsor

i-Lumen Scientific, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05447650

Collaborator

(none)

Enrollment

Locations

Arms

22.6

Anticipated Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Age-Related Macular Degeneration Dry Age-related Macular Degeneration Nonexudative Age-related Macular Degeneration	Device: i-Lumen(TM) AMD Device: i-Lumen(TM) AMD Sham	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Apr 12, 2022

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: i-Lumen AMD Active Active transpalpebral microcurrent stimulation therapy	Device: i-Lumen(TM) AMD Transpalpebral microcrurrent stimulation
Sham Comparator: i-Lumen AMD Sham Sham transpalpebral microcurrent stimulation therapy	Device: i-Lumen(TM) AMD Sham Transpalpebral sham stimulation

Arm

Intervention/Treatment

Experimental: i-Lumen AMD Active

Active transpalpebral microcurrent stimulation therapy

Device: i-Lumen(TM) AMD

Transpalpebral microcrurrent stimulation

Sham Comparator: i-Lumen AMD Sham

Sham transpalpebral microcurrent stimulation therapy

Device: i-Lumen(TM) AMD Sham

Transpalpebral sham stimulation

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Mean change best corrected distance visual acuity [Through Month 12 timepoint]
Mean change from baseline of best corrected distance visual acuity (CDVA) letter score

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

Age ≥50 years.
Non-exudative age-related macular degeneration defined as AREDS category 3 Intermediate AMD
Best-corrected distance visual acuity 20/63 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)
Geographic atrophy in the study eye
Central chorioretinal atrophy in the study eye
Glaucoma in the study eye

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Associated Retina Consultants	Phoenix	Arizona	United States	85020
2	Cumberland Valley Retina Consultants	Chambersburg	Pennsylvania	United States	21740

Sponsors and Collaborators

i-Lumen Scientific, Inc.

Investigators

Study Director: Meredith Mundy, i-Lumen Scientific, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

i-Lumen Scientific, Inc.

ClinicalTrials.gov Identifier:

NCT05447650

Other Study ID Numbers:

ILS-AMD-201

First Posted:

Jul 7, 2022

Last Update Posted:

Jul 13, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by i-Lumen Scientific, Inc.

AMD

Dry AMD

Additional relevant MeSH terms:

Macular Degeneration

Geographic Atrophy

Study Results

No Results Posted as of Jul 13, 2022