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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
i-Lumen AMD transpalpebral microcurrent stimulation system
Eye Clinic Albury-Wodonga
Albury, New South Wales, Australia
RECRUITINGSydney Eye Hospital
Sydney, New South Wales, Australia
RECRUITINGHobart Eye Surgeons
Hobart, Tasmania, Australia
RECRUITINGAdelaide Eye & Retina Centre
Adelaide, Victoria, Australia
RECRUITINGCerulea
East Melbourne, Victoria, Australia
RECRUITINGAuckland Eye Limited
Remuera, Auckland, New Zealand
RECRUITINGSouthern Eye Specialist
Christchurch, New Zealand
RECRUITINGKing's College Hospital
London, United Kingdom
RECRUITINGLondon North West University Healthcare
Middlesex, United Kingdom
RECRUITINGMean Change BCVA from Baseline
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.
Time frame: Month 3
Portion of per-eye Responders
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.
Time frame: Month 3
Mean Change BCVA from Baseline
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.
Time frame: Month 6
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