Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration

Launched by I-LUMEN SCIENTIFIC AUS PTY LTD · Oct 25, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called microcurrent stimulation therapy using a device called the i-Lumen AMD. The goal is to see if this therapy can be safe and effective for people with intermediate to advanced nonexudative age-related macular degeneration (AMD), a condition that affects vision. Participants in the trial will start with an initial set of treatments, followed by maintenance sessions over 11 months, and will return once a month for evaluations for a total of 14 months.

To qualify for this trial, participants need to have certain characteristics, such as having at least one large druse (a type of eye deposit) due to AMD and a specific range of vision scores. However, there are several factors that may exclude someone from participating, such as having certain medical devices implanted, uncontrolled diabetes, or a history of specific eye conditions. This trial is not yet recruiting participants, but it is an important step in exploring new ways to help those affected by AMD.

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Eligibility criteria

• Key Inclusion Criteria:
• • Presence of at least one large druse \>125 microns in diameter due to AMD.
• • BCVA letter score of 35 to 70 letters (inclusive) (Snellen equivalent 6/12 to 6/60 \[20/40 to 20/200\])
• Key Exclusion Criteria:
• • Any implanted electrical device(s) including deep brain stimulator, hearing or visual implants (i.e., cochlear implant, auditory brainstem implant, retinal prostheses), and/or cardiac defibrillator/pacemaker.
• • Implanted metallic device within 20 cm of the Treatment electrode (study eye(s)) and/or the grounding electrode (base of the hairline on the back of the neck).
• • Uncontrolled diabetes, defined as glycated haemoglobin (HbA1c) \>10% (13.3 mmol/L).
• • Current tobacco or tobacco-related product use or history within the past 5 years of heavy smoking (defined as, on average, more than half a pack of cigarettes per day).
• • Known severe allergy to fluorescein dye.
• • Medical diagnosis of severe dry eye defined as requiring either artificial tears more than six (6) times a day or prescription drops (i.e., Restasis, Xiidra, or Cequa).
• • History of seizure disorders, chronic migraines and/or cluster headaches.
• • History and/or evidence of diabetic retinopathy in either eye as assessed by CF, fundus fluorescein angiography (FA), and OCT, to be confirmed by the Central Reading Centre.
• • Other conditions which pre-dispose to chorioretinal atrophy such as inherited retinal dystrophy (i.e., Stargardt's disease, Best's disease, pattern dystrophy, central areolar choroidal dystrophy, etc.).
• • History and/or evidence of exudative AMD in the study eye as assessed by CF, FA (or OCT-A ), and OCT, to be confirmed by Central Reading Centre.
• • GA involving the foveal centre, as assessed by the Central Reading Centre using AF and OCT.
• • History of intravitreal injections for GA (e.g., Syfovre or Izervay).
• • Treatment with photobiomodulation (PBM) therapy or short pulse laser within 12 months prior to screening.
• • Glaucoma requiring ≥3 medications and/or drops per day, or history of trabeculectomy.
• • History of any kind of intraocular surgery, excluding cataract surgery performed ≥3 months from Screening.
• • History of yttrium aluminium garnet (YAG) laser posterior capsulotomy \<1 month from Screening.
• • Visually significant cataracts and/or visually significant posterior capsular opacification.
• • History of amblyopia.