Clinical trial NCT06662162: Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration
Official title: Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration (i-SIGHT2): a Multicentre, Randomised, Sham-controlled, Double-masked, Clinical Device Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Age-Related Macular Degeneration
Age-related Macular Degeneration (ARMD)
Intermediate AMD
Geographic Atrophy Secondary to Age-related Macular Degeneration
Keywords: AMD
Intermediate AMD
Dry AMD
Geographic Atrophy
Lead sponsor: i-Lumen Scientific AUS PTY LTD
Sponsor class: INDUSTRY
Collaborators: name: i-Lumen Scientific, Inc.
First posted: 2024-10-28
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2:1 Randomization of active to sham therapy
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Mean Change BCVA from Baseline
timeFrame: Month 3
Secondary outcomes:
measure: Portion of per-eye Responders
timeFrame: Month 3
measure: Mean Change BCVA from Baseline
timeFrame: Month 6
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Adelaide Eye & Retina Centre
state: Victoria
city: East Melbourne
country: Australia
facility: Cerulea
state: Victoria
city: Remuera
country: New Zealand
facility: Auckland Eye Limited
state: Auckland
city: Christchurch
country: New Zealand
facility: Southern Eye Specialist
Study officials:
affiliation: i-Lumen Scientific AUS PTY LTD
name: Meredith Mundy
role: STUDY_DIRECTOR
References: