[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intermediate-amd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intermediate-amd":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100640940","macutherm-performance-study-in-patients-with-iamd-100640940",false,"NCT07607496","MacuTherm Performance Study in Patients With iAMD","Individualized Navigated Photothermal Therapy in Patients With Intermediate AMD: A Randomized, Double-Blinded, Controlled Clinical Trial to Evaluate the Performance of theTherapy Proposed by Macula Explorer Using Navilas Laser System","Key Inclusion Criteria:\n\n* Male, female, or diverse\n* Age of 60 to 90 years old\n* Clinically confirmed intermediate AMD (iAMD, AREDS category 3) with the presence of:\n\n  * At least 3 large drusen (diameter \\> 125 μm) within the inner ring of 3mm diameter of the ETDRS Grid centered on the fovea (with or without reticular pseudodrusen (RPE))\n  * combined with at least 1 of the following other signs:\n\n    * Incomplete RPE and outer retinal atrophy (i-RORA) outside central 1mm ring and\u002For\n    * Hyperreflective foci (HRF) adjacent to drusen (within 3 mm)\n* Best corrected visual acuity between 65 and 87 letters\n* Clear optic media\n* Ability to communicate clearly and to understand and comply with the nature and requirements of the study\n* Ability to provide written informed consent in accordance with institutional, local and national regulatory guidelines\n* Willing to participate\n\nExclusion Criteria:\n\n* Presence of late-stage AMD, neovascular (nAMD, active or fibrotic) or geographic atrophy (GA)\n* Maculopathies showing only pseudodrusen\n* Any systemic medication known to be toxic to the lens, retina or optic nerve\n* Any intraocular surgery within 6 months prior to study inclusion (except uncomplicated cataract surgery \\> 3 months)\n* Any previous thermal laser treatment in the macula\n* History of vitrectomy, filter surgery, corneal transplantation or retinal detachment\n* Previous therapeutic radiotherapy in the eye region\n* Pregnant or breast-feeding patients\n* Participation in an investigational drug, biologic or device study within 6 months prior to study entry (Note: observational clinical studies involving only over-the-counter vitamins, supplements or diets are not excluded)\n* Expected participation in an investigational drug, biologic or device study during the duration of this clinical investigation except clinical investigations for diagnostic purposes where examinations are not influencing the outcome of the current clinical investigation. Mandatory for participation in this additional clinical investigation is prior approval from the sponsor of this clinical investigation in writing\n* A serious medical condition that prevents the patient from performing study activities (including cardiac, hepatic, renal, respiratory, endocrinological, neurological or haematological conditions) or, in the opinion of the investigator, is likely to require surgery or hospitalization (at any time during his\u002Fher participation on this clinical investigation)\n* Known allergy to any ingredient required (for dilation of the pupil, if no alternative agent may be applied) or any contraindication to be treated with Navilas® Laser System 577SL\n* If, in the opinion of the investigator, it is unlikely that the study protocol will be followed\n\nIf only one eye is eligible for inclusion, none of the following criteria must be present in the fellow eye in order to allow inclusion of the study eye:\n\n* Presence of late-stage AMD in need of therapy\n* Presence of neovascular AMD (nAMD) in need of therapy\n* Presence of geographic atrophy (GA) in need of therapy (e.g. complement-inhibitors)\n* All the non-AMD eye diseases mentioned for the study eye as exclusion criteria\n* Previous therapeutic radiotherapy in the fellow eye region","ALL","60 Years","90 Years",{"count":20,"type":21},240,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this study is to demonstrate that photothermal therapy with the individually dosed treatment plan proposed by Macula Explorer delivered safely by Navilas® Laser System effectively improves the life of photoreceptors and reduces the progression of intermediate Age-related Macular Degeneration (iAMD) and preserves photoreceptors shown by Ellipsoid Zone Integrity (EZI).\n\nParticipants will be randomized to either Treatment or Control Group. There will be 12 visits, monthly for the first 3 months, then quarterly until the end of the study after 2 years.",[27],"Intermediate AMD",[29,30],"MacuTherm Trial","iAMD","RECRUITING","2026-06-02",{"date":34,"type":35},"2026-06-04","ACTUAL",{"date":37,"type":35},"2026-05-29",{"date":39,"type":21},"2028-12",{"name":41,"class":42},"OD-OS MacuTherm GmbH","INDUSTRY",4,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100566975","microcurrent-stimulation-therapy-for-intermediate-to-advanced-nonexudative-age-related-macular-degeneration-100566975","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.",{"count":53,"type":21},100,[24],"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.",[57,58,27,59],"Age-Related Macular Degeneration","Age-related Macular Degeneration (ARMD)","Geographic Atrophy Secondary to Age-related Macular Degeneration",[61,27,62,63],"AMD","Dry AMD","Geographic Atrophy","2026-05-01",{"date":66,"type":35},"2026-05-04",{"date":68,"type":35},"2025-05-07",{"date":70,"type":21},"2029-12-31",{"name":72,"class":42},"i-Lumen Scientific AUS PTY LTD",13,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100558918","a-clinical-trial-evaluating-the-safety-and-efficacy-of-a-new-light-combination-therapy-addressing-intermediate-amd-100558918","NCT06557369","A Clinical Trial Evaluating the Safety and Efficacy of a New Light Combination Therapy Addressing Intermediate AMD","A Prospective Proof-of-Concept Clinical Investigation to Evaluate Safety and Effectiveness of reSEES in Patients With Intermediate Age-Related Macular Degeneration","retinaSEES-PoC","Inclusion Criteria:\n\n* Male and female patients ≥ 50 years of age\n* Intermediate AMD, Grade AREDS 3\n* Both eyes eligible for the study Patients willing to enrol in a clinical study must sign a written informed consent form, cooperate with protocols, and comply with follow-up.\n* Dietary supplements and life-style habits must remain unchanged, as far as possible, for the duration of investigation participation.\n\nExclusion Criteria:\n\n* Myopia \\> 8D\n* Maximum pupillary aperture ᴓ4mm with medical dilation\n* Anticipation of ocular surgery during the study\n* Clinically significative cataract\n* Ocular surgery 6 months or less before study entry\n* No previous retinal treatment, neither anti-VEGF (Anti-Vascular Endothelial Growth Factor ) therapy nor laser photocoagulation\n* Diabetic retinopathy\n* Any other maculopathy and conditions as e.g. retinitis pigmentosa, DME (diabetic macular oedema), retinal lesions, retinal vessel occlusions etc\n* Another obfuscating ocular disease including amblyopia, uncontrolled IOP (intraocular pressure), uncontrolled glaucoma or glaucomatous visual field loss, media opacity such as visually significant cataract, epiretinal membrane, vitreomacular traction, etc\n* Concomitant systemic diseases and factors affecting the study, as per investigator's discretion\n* Pregnant and lactating woman\n* Concomitant participation in another interventional clinical study\n* When it is expected that the patient will not be able to complete the trial due to mental health, age, or other personal issues.\n* Photosensitivity","50 Years",{"count":84,"type":21},30,[24],"The proposed clinical investigation wants primary to validate the safety of the innovative light therapy approach and in second priority provide insight and confirmations on therapeutic effect.\n\nBy combining two clinically standard laser-light treatment, both exhibiting a solid-safe profile: the photothermal and the photobiological techniques; the investigational device (reSEES) wants to explore a completely new therapeutic approach by synergically take advantage of the inherent and already observed clinical performances of the two independent techniques.",[27],[89,90,91,92,93,30,94,95,96,97,98,99,100,101,102],"phototherapy","subthreshold","laser","Retina","amd","photo biomodulation","hyperthermia","mitochondria","choriocapillaris","Para inflammation","cco","RPE","retinal pigment epithelium","chromophore","2024-11-13",{"date":105,"type":35},"2024-11-15",{"date":107,"type":21},"2024-11",{"date":109,"type":21},"2025-12",{"name":111,"class":42},"Oculox Technologies SA",1]