Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT)
i-SIGHT
1 other identifier
interventional
95
1 country
10
Brief Summary
Evaluate the safety and efficacy of transpalpebral microcurrent stimulation (MCS) therapy for patients with nonexudative (dry) age-related macular degeneration (AMD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2022
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 12, 2022
CompletedFirst Submitted
Initial submission to the registry
June 29, 2022
CompletedFirst Posted
Study publicly available on registry
July 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2025
CompletedJune 24, 2025
June 1, 2025
3.2 years
June 29, 2022
June 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Other Outcomes (1)
Mean change best corrected distance visual acuity
Through Month 12 timepoint
Study Arms (2)
i-Lumen AMD Active
EXPERIMENTALActive transpalpebral microcurrent stimulation therapy
i-Lumen AMD Sham
SHAM COMPARATORSham transpalpebral microcurrent stimulation therapy
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Associated Retina Consultants
Phoenix, Arizona, 85020, United States
Bay Area Retina Associates
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Meredith Mundy
i-Lumen Scientific, Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2022
First Posted
July 7, 2022
Study Start
April 12, 2022
Primary Completion
June 15, 2025
Study Completion
June 15, 2025
Last Updated
June 24, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share