[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"i-Lumen Scientific AUS PTY LTD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100566975","microcurrent-stimulation-therapy-for-intermediate-to-advanced-nonexudative-age-related-macular-degeneration-100566975",false,"NCT06662162","Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration","Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration (i-SIGHT2): a Multicentre, Randomised, Sham-controlled, Double-masked, Clinical Device Trial.","i-SIGHT2","Key Inclusion Criteria:\n\n* Presence of at least one large druse \\>125 microns in diameter due to AMD.\n* BCVA letter score of 35 to 70 letters (inclusive) (Snellen equivalent 6\u002F12 to 6\u002F60 \\[20\u002F40 to 20\u002F200\\])\n\nKey Exclusion Criteria:\n\n* Any implanted electrical device(s) including deep brain stimulator, hearing or visual implants (i.e., cochlear implant, auditory brainstem implant, retinal prostheses), and\u002For cardiac defibrillator\u002Fpacemaker.\n* Implanted metallic device within 20 cm of the Treatment electrode (study eye(s)) and\u002For the grounding electrode (base of the hairline on the back of the neck).\n* Uncontrolled diabetes, defined as glycated haemoglobin (HbA1c) \\>10% (13.3 mmol\u002FL).\n* 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).\n* Known severe allergy to fluorescein dye.\n* 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).\n* History of seizure disorders, chronic migraines and\u002For cluster headaches.\n* History and\u002For 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.\n* 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.).\n* History and\u002For 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.\n* GA involving the foveal centre, as assessed by the Central Reading Centre using AF and OCT.\n* History of intravitreal injections for GA (e.g., Syfovre or Izervay).\n* Treatment with photobiomodulation (PBM) therapy or short pulse laser within 12 months prior to screening.\n* Glaucoma requiring ≥3 medications and\u002For drops per day, or history of trabeculectomy.\n* History of any kind of intraocular surgery, excluding cataract surgery performed ≥3 months from Screening.\n* History of yttrium aluminium garnet (YAG) laser posterior capsulotomy \\\u003C1 month from Screening.\n* Visually significant cataracts and\u002For visually significant posterior capsular opacification.\n* History of amblyopia.","ALL","60 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.\n\nParticipants will:\n\n* Undergo an initial loading regimen, followed by 7 maintenance over the course of 11 months.\n* Participants will return monthly through Month 14 (3 months post-last treatment) for evaluation and monitoring.",[27,28,29,30],"Age-Related Macular Degeneration","Age-related Macular Degeneration (ARMD)","Intermediate AMD","Geographic Atrophy Secondary to Age-related Macular Degeneration",[32,29,33,34],"AMD","Dry AMD","Geographic Atrophy","RECRUITING","2026-05-01",{"date":38,"type":39},"2026-05-04","ACTUAL",{"date":41,"type":39},"2025-05-07",{"date":43,"type":21},"2029-12-31",{"name":45,"class":46},"i-Lumen Scientific AUS PTY LTD","INDUSTRY",13,""]