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New treatment option for Age-Related Macular Degeneration
Official title Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration
ClinicalTrials.gov ID: NCT06662162
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- 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
You likely can't join if
- Any implanted electrical device(s) including deep brain stimulator, hearing or visual implants (i.e., cochlear implant, auditory brainstem implant...
- 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...
- 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...
- 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...
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Manchester, Connecticut, United States
- Lemont, Illinois, United States
- Reno, Nevada, United States
- Fort Worth, Texas, United States
- Tyler, Texas, United States
- Sydney, New South Wales, Australia
- Hobart, Tasmania, Australia
- Adelaide, Victoria, Australia
- East Melbourne, Victoria, Australia
- Remuera, Auckland, New Zealand
- Christchurch, New Zealand
- Belfast, United Kingdom
- London, United Kingdom
- Middlesex, United Kingdom
- Sunderland, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Manchester, Connecticut, United States; Lemont, Illinois, United States; Reno, Nevada, United States; Fort Worth, Texas, United States; Tyler, Texas, United States; Sydney, New South Wales, Australia and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.