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 San Diego
Poway, California, United States
RECRUITINGRetina Consultants PC
Manchester, Connecticut, United States
RECRUITINGUniversity Retina & Macula Associates
Lemont, Illinois, United States
RECRUITINGSierra Eye Associates
Reno, Nevada, United States
NOT_YET_RECRUITINGRetina Associates of Cleveland
Beachwood, Ohio, United States
RECRUITINGTexas Retina Associates
Fort Worth, Texas, United States
RECRUITINGTyler Retina Research Insitute
Tyler, Texas, United States
RECRUITINGCerulea
East Melbourne, Victoria, Australia
ACTIVE_NOT_RECRUITINGAuckland Eye Limited
Remuera, Auckland, New Zealand
RECRUITINGQueens University Belfast / Belfast City Hospital
Belfast, United Kingdom
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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