Microcurrent therapy for advanced age-related macular degeneration

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of the i-Lumen AMD transpalpebral microcurrent device in patients with intermediate to advanced nonexudative age-related macular degeneration (AMD). Participants will undergo an initial loading regimen followed by seven maintenance sessions over 11 months, with monthly evaluations for three months post-treatment. The study aims to determine how this therapy impacts vision and overall eye health in affected individuals.

Why it matters

Who can join: the full rules

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.

Where it's running

• Retina Consultants San Diego
  Poway, California, United States Recruiting
• Retina Consultants PC
  Manchester, Connecticut, United States Recruiting
• University Retina & Macula Associates
  Lemont, Illinois, United States Recruiting
• Retina Associates of Cleveland
  Beachwood, Ohio, United States Recruiting
• Texas Retina Associates
  Fort Worth, Texas, United States Recruiting
• Tyler Retina Research Insitute
  Tyler, Texas, United States Recruiting

Study contacts

• Study coordinator: Meredith Mundy
• Email: mmundy@i-lumen.com
• Phone: 408-440-7049

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.