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Microcurrent Stimulation for Dry Age-related Macular Degeneration

Microcurrent Stimulation Therapy for Dry Age-related Macular Degeneration (i-SIGHT): a Multicenter, Randomized, Double-masked, Clinical Device Trial

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04511936
Acronym
i-SIGHT
Enrollment
0
Registered
2020-08-13
Start date
2021-03-01
Completion date
2023-01-31
Last updated
2021-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Age-related Macular Degeneration

Keywords

AMD, Dry AMD

Brief summary

Evaluate the safety and efficacy of microcurrent stimulation therapy for patients with dry age-related macular degeneration.

Detailed description

Multi-center, double-masked, randomized trial of microcurrent stimulation for the treatment of patients affected with dry age-related macular degeneration.

Interventions

Microcurrent stimulator

DEVICEi-Lumen AMD Sham

Sham microcurrent stimulator

Sponsors

i-Lumen Scientific, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Key Inclusion Criteria - Study Eye: * Dry AMD diagnosis. Key

Exclusion criteria

- Study Eye: * Wet AMD

Design outcomes

Primary

MeasureTime frame
Mean change from baseline in best-corrected distance visual acuity (CDVA) at one month timepoint.1 Month

Secondary

MeasureTime frame
Best-corrected distance visual acuity (CDVA) response rate at 1 month visit.1 Month

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026