Age-Related Macular Degeneration, Age-related Macular Degeneration (ARMD), Geographic Atrophy Secondary to Age-related Macular Degeneration, Intermediate AMD
Conditions
Keywords
AMD, Intermediate AMD, Dry AMD, Geographic Atrophy
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.
Interventions
DEVICEi-Lumen AMD
i-Lumen AMD transpalpebral microcurrent stimulation system
Sponsors
i-Lumen Scientific AUS PTY LTD
i-Lumen Scientific, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
2:1 Randomization of active to sham therapy
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change BCVA from Baseline | Month 3 | Mean change in per-eye (treated study eye \[unilateral\] or treated primary study eye \[bilateral\]) from Baseline in distance BCVA letter score on the ETDRS VA chart, active vs sham. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Portion of per-eye Responders | Month 3 | 1\. Difference in proportion of per-eye (treated study eye \[unilateral\] or treated primary study eye \[bilateral\]) gaining ≥10 letters from Baseline in distance BCVA ETDRS, active vs sham. |
| Mean Change BCVA from Baseline | Month 6 | Mean change in per-eye (treated study eye \[unilateral\] or treated primary study eye \[bilateral\]) from Baseline in distance BCVA letter score on the ETDRS VA chart, active vs sham. |
Countries
Australia, New Zealand, United Kingdom, United States
Contacts
CONTACTMeredith Mundy
STUDY_DIRECTORMeredith Mundy
i-Lumen Scientific, Inc.
Outcome results
None listed