i-SIGHT2, Version C
Research type
Research Study
Full title
MICROCURRENT STIMULATION THERAPY FOR INTERMEDIATE TO ADVANCED NONEXUDATIVE AGE-RELATED MACULAR DEGENERATION (i-SIGHT2): A MULTICENTER, RANDOMISED, SHAM-CONTROLLED, DOUBLE-MASKED, PILOT CLINICAL DEVICE TRIAL
IRAS ID
339565
Contact name
Meredith Mundy
Contact email
Sponsor organisation
i-Lumen Scientific
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, 31 days
Research summary
Age-related macular degeneration (AMD) is a complex retinal disease that is a leading cause of visual impairment and blindness globally for adults age 60 and older. AMD refers to a chronic and progressive degeneration of the cells within the retina responsible for vision. Advancement of the disease results in progressive loss of vision. While up to 15% of the AMD population are affected by advanced exudative AMD, the remaining early, intermediate, and advanced nonexudative AMD population have historically had few clinical treatment options available.
The aim of this study it to investigate the safety and efficacy of a new device called i-Lumen AMD therapy for the treatment of intermediate to advanced dry AMD. The device uses microcurrent stimulation therapy: it delivers an electrical current to the retina through electrodes placed on the closed eyelids. The therapy aims to restore cellular metabolism and restarts the neural pathway.
The study will enroll up to 120 participants, and is a multicenter, randomised (two-thirds of the patients get the active treatment and one-third of the patients get a sham/inactive treatment), double-masked (both the patients and the research personnel are masked as to what treatment patients receive) clinical trial. Recruitment will take place at multiple clinical sites in NHS hospitals in the UK and in Australia and New Zealand.
Each participant will have i-Lumen AMD therapy, either active or sham, in the study eye(s) over five consecutive days for the initial treatment period, followed by one day “maintenance” treatments at the 1, 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, and 23-month follow-up timepoints. Follow-up duration is 24 months.
Main expected potential benefits are an improvement in best-corrected visual acuity, and slowing disease progression.
Research if funded by the manufacturer i-Lumen Scientific, Inc.REC name
London - Stanmore Research Ethics Committee
REC reference
25/LO/0491
Date of REC Opinion
12 Aug 2025
REC opinion
Further Information Favourable Opinion