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
Retina Consultants PC
Manchester, Connecticut, United States
NOT_YET_RECRUITINGUniversity Retina & Macula Associates
Lemont, Illinois, United States
NOT_YET_RECRUITINGTexas Retina Associates
Fort Worth, Texas, United States
NOT_YET_RECRUITINGTyler Retina Research Insitute
Tyler, Texas, United States
NOT_YET_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
RECRUITING...and 3 more locations
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 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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