[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"optic-nerve-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:optic-nerve-disease":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,90],{"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":45,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":89},"100286660","stem-cell-ophthalmology-treatment-study-ii-100286660",false,"NCT03011541","Stem Cell Ophthalmology Treatment Study II","Bone Marrow Derived Stem Cell Ophthalmology Treatment Study II","SCOTS2","Inclusion Criteria:\n\n* Have objective, documented damage to the retina or optic nerve unlikely to improve OR\n* Have objective, documented damage to the retina or optic nerve that is progressive AND have less than or equal to 20\u002F30 best corrected central visual acuity in one or both eyes AND\u002FOR an abnormal visual field in one or both eyes.\n* Be at least 3 months post-surgical treatment intended to treat any ophthalmologic disease and stable.\n* If under current medical therapy ( pharmacologic treatment) for a retinal or optic nerve disease be considered stable on that treatment and unlikely to have visual function improvement ( for example, glaucoma with intraocular pressure stable on topical medications but visual field damage ).\n* Have the potential for improvement with BMSC treatment and be at minimal risk of any potential harm from the procedure.\n* Be over the age of 18\n* Be medically stable and able to be medically cleared by their primary care physician or a licensed primary care practitioner for the procedure.\n* Medical clearance means that in the estimation of the primary care practitioner, the patient can reasonably be expected to undergo the procedure without significant medical risk to health.\n\nExclusion Criteria:\n\n* Patients who are not capable of an adequate ophthalmologic examination or evaluation to document the pathology.\n* Patients who are not capable or not willing to undergo follow up eye exams with the principle investigator or their ophthalmologist or optometrist as outlined in the protocol.\n* Patients who are not capable of providing informed consent.\n* Patients who may be at significant risk to general health or to the eyes and visual function should they undergo the procedure.","ALL","18 Years",{"count":20,"type":21},500,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study will evaluate the use of autologous bone marrow derived stem cells (BMSC) for the treatment of retinal and optic nerve damage or disease.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"Retinal Disease","Age-Related Macular Degeneration","Retinitis Pigmentosa","Stargardt Disease","Optic Neuropathy","Nonarteritic Ischemic Optic Neuropathy","Optic Atrophy","Optic Nerve Disease","Glaucoma","Leber Hereditary Optic Neuropathy","Blindness","Vision Loss Night","Vision Loss Partial","Vision, Low","Retinopathy","Maculopathy","Macular Degeneration","Retina Atrophy",[46,47,48,49,50,51,52,53,54,27,43,55,56,57,58,59,60,61,62,63,29,30,64,65,66,42,34,33,31,67,68,69,70,71,72,73,74,75,36,37,76,44],"Stem Cells","Bone Marrow Derived Stem Cells","BMSC","Mesenchymal Stem Cells","MSC","Eye Disease","Ophthalmology","Ophthalmic Disease","Retina","Age Related Macular Degeneration","Myopic Macular Degeneration","Geographic Atrophy","Dry Macular Degeneration","Wet Macular Degeneration","Retinal Atrophy","Retinal Dystrophy","Hereditary Retinal Dystrophy","Malattia Leventinese","Cone Dystrophy","Rod-Cone Dystrophy","Cone-Rod Dystrophy","Ischemic Optic Neuropathy","Optic Nerve Damage","Optic Nerve Compression","Compressive Optic Neuropathy","Devics Syndrome","Ushers Syndrome","Neuromyelitis Optica","Dominant Optic Atrophy","Kjers Optic Atrophy","Vision Loss","RECRUITING","2026-06-24",{"date":80,"type":81},"2026-06-29","ACTUAL",{"date":83,"type":81},"2016-01",{"date":85,"type":21},"2028-07-31",{"name":87,"class":88},"MD Stem Cells","INDUSTRY",4,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":17,"minAge":98,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":119},"100612829","phase-1-pilot-study-of-the-efficacy-of-nicotinamide-vitamin-b3-in-lebers-hereditary-optic-neuropathy-100612829","NCT07258667","Pilot Study of the Efficacy of Nicotinamide (Vitamin B3) in Leber's Hereditary Optic Neuropathy","NICOLHON - Pilot Study of the Efficacy of Nicotinamide (Vitamin B3) in Leber's Hereditary Optic Neuropathy","NICOLHON","Inclusion Criteria:\n\n* Patients aged 16 years or older.\n* Diagnosis of Leber Hereditary Optic Neuropathy (LHON) due to a confirmed mitochondrial DNA mutation m.11778G\\>A or m.3460G\\>A.\n* Onset of LHON symptoms less than 18 months before inclusion.\n* Naïve to nicotinamide treatment for at least 3 months prior to inclusion.\n* Able to take oral medication and comply with study procedures.\n* Affiliated with or beneficiary of a social security system.\n* Signed informed consent (or parental consent for minors; assent for minors when applicable).\n\nExclusion Criteria:\n\n* Asymptomatic carriers of m.11778G\\>A or m.3460G\\>A mutations (no clinical LHON).\n* LHON due to other mitochondrial DNA mutations or nuclear DNA mutations.\n* LHON onset more than 18 months before inclusion.\n* Current or recent treatment with idebenone (within 3 months).\n* Severe associated ophthalmologic disease (e.g., advanced glaucoma, retinal pathology).\n* Patients treated with gene therapy.\n* Elevated liver enzymes (ASAT and\u002For ALAT \\> 2× upper normal limit) at screening or within 2 months prior to inclusion.\n* Pregnant, breastfeeding, or postpartum women.\n* Known contraindication to nicotinamide or allergy\u002Fintolerance to lactose or galactose.\n* Persons deprived of liberty by judicial or administrative decision.\n* Subjects under legal protection or psychiatric care under constraint.\n* Unable to provide informed consent.\n* Participation in another interventional study affecting LHON management.\n* Any condition that, in the investigator's judgment, could compromise patient safety or study integrity.","16 Years",{"count":100,"type":21},13,[102],"PHASE1","Leber Hereditary Optic Neuropathy (LHON) is a rare genetic disease that causes sudden and severe vision loss, usually in young adults. It is linked to mutations in mitochondrial DNA that impair energy production in retinal ganglion cells, leading to degeneration of the optic nerve. Currently, treatment options are very limited and often ineffective. Recent research has shown that patients with LHON have lower levels of nicotinamide (vitamin B3), a key molecule for mitochondrial energy metabolism. Nicotinamide is a precursor of NAD, an essential cofactor for cellular energy production. Experimental studies and clinical trials in related optic nerve diseases suggest that nicotinamide may protect retinal ganglion cells. Our hypothesis is that supplementation with high-dose nicotinamide could restore NAD levels, support mitochondrial activity, and help preserve or improve vision in LHON. This pilot study will evaluate the effectiveness and safety of oral nicotinamide (2 grams per day for 12 months) in patients who developed LHON within the past 18 months and carry one of the two most severe mutations (m.11778G\\>A or m.3460G\\>A). The main goal is to measure changes in visual acuity over time using standardized eye charts. Secondary objectives include assessing visual fields, retinal structure by optical coherence tomography (OCT), blood nicotinamide levels, and quality of life. Liver function will be monitored to ensure safety. If this study shows promising results, it could pave the way for a larger randomized trial and ultimately offer a new therapeutic option.",[105,106,107,34],"Leber Hereditary Optic Neuropathy (LHON)","Leber's Hereditary Optic Neuropathy (LHON)","Mitochondrial Disease","NOT_YET_RECRUITING","2025-12-11",{"date":111,"type":81},"2025-12-18",{"date":113,"type":21},"2026-04",{"date":115,"type":21},"2028-04",{"name":117,"class":118},"University Hospital, Angers","OTHER_GOV",1]