Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration (i-SIGHT2)

i-Lumen Scientific AUS PTY LTD

Status: Not yet enrolling

Conditions: Geographic Atrophy Secondary to Age-related Macular Degeneration; Intermediate AMD; Age-Related Macular Degeneration; Age-related Macular Degeneration (ARMD)

Treatments: Device: i-Lumen AMD

Study type: Interventional

Funder types: Industry

Identifiers

NCT06662162

ILS-AMD-202

Details and patient eligibility

About

The goal of this clinical trial is to characterize the safety and effectiveness of the i-Lumen AMD transpalpebral microcurrent device and therapy in patients with intermediate to advanced nonexudative AMD.

Participants will:

• Undergo an initial loading regimen, followed by 7 maintenance over the course of 11 months.
• Participants will return monthly through Month 14 (3 months post-last treatment) for evaluation and monitoring.

Enrollment: 100 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Active i-Lumen AMD therapy

Experimental group

Description:

Active transpalpebral microcurrent therapy

Treatment:

Device: i-Lumen AMD

Sham i-Lumen AMD therapy

Sham Comparator group

Description:

Sham transpalpebral microcurrent therapy

Treatment:

Device: i-Lumen AMD