[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"optic-neuritis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:optic-neuritis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,54,85,115,144,171,198,221,242,261,298],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100639759","phase-3-privosegtor-investigation-in-optic-neuropathies-efficacy-evaluation-research-100639759",false,"NCT07623668","Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research","A Randomized, Double-masked, Placebo-controlled Study Assessing the Efficacy and Safety of Privosegtor (OCS-05) in Patients With Optic Neuritis (ON)","PIONEER-1","Key Inclusion Criteria:\n\n* Adult men and women (aged 18 to 50 years) with the first episode of ON in the study eye, associated with unilateral visual loss.\n* Onset of visual loss symptoms in the previous 12 days before first administration of study treatment.\n\nKey Exclusion Criteria:\n\n\\- Have a history or presence of any disorder or condition that may, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety","ALL","18 Years","50 Years",{"count":21,"type":22},210,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The goal of this clinical trial is to evaluate the safety and efficacy of privosegtor, a neuroprotective candidate, in patients diagnosed with optic neuritis (ON).\n\nResearchers will compare privosegtor and the standard of care (methylprednisolone) to a placebo and standard of care (methylprednisolone).",[28],"Optic Neuritis",[28,30,31,32,33,34,35,36,37,38,39,40],"ON","AON","Optic Neuropathy","Multiple Sclerosis","MS","Vision Loss","LCVA","Low Contrast Visual Acuity","Low Contrast Sensitivity","Privosegtor","OCS-05","RECRUITING","2026-06-29",{"date":44,"type":45},"2026-07-01","ACTUAL",{"date":47,"type":45},"2026-05-28",{"date":49,"type":22},"2028-12",{"name":51,"class":52},"Oculis","INDUSTRY",2,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100642118","prospective-evaluation-of-the-2022-optic-neuritis-criteria-when-optic-neuritis-is-suspected-100642118","NCT07623252","Prospective Evaluation of the 2022 Optic Neuritis Criteria When Optic Neuritis Is Suspected","A Multicenter Prospective Diagnostic Accuracy Study of the 2022 International Criteria for Optic Neuritis and an Antibody-Stratified Adjunct in Acute or Subacute Visual Loss When Optic Neuritis Is Suspected in China","GX-ICON","Inclusion Criteria:\n\n1. Individuals presenting with a new acute or subacute episode of visual loss or optic nerve-related visual dysfunction in one or both eyes, for whom optic neuritis is considered a reasonable differential diagnosis by the treating clinical team at the initial clinical assessment and before final diagnostic adjudication.\n2. Symptom onset of the current episode within 90 days before enrollment.\n\nExclusion Criteria:\n\n1\\. The participant has previously been enrolled in this study. Each participant may be enrolled only once.\n\nA history of optic neuritis or recurrent optic neuropathy before the current episode is not an exclusion criterion.",{"count":63,"type":22},500,"OBSERVATIONAL","Optic neuritis is an important cause of acute or subacute visual loss. In clinical practice, optic neuritis must often be distinguished from other optic neuropathies, retinal diseases, anterior-segment or ocular media disorders, non-organic visual loss, and other mimics. The 2022 International Criteria for Optic Neuritis were developed to standardize the diagnosis of optic neuritis, but their performance in Chinese clinical settings, where aquaporin-4 immunoglobulin G-positive and myelin oligodendrocyte glycoprotein immunoglobulin G-positive optic neuritis are relatively common, remains uncertain.\n\nThis multicenter prospective observational study is enrolling patients with acute or subacute visual loss in whom optic neuritis is included in the differential diagnosis. The study is designed to evaluate the diagnostic performance of the 2022 International Criteria for Optic Neuritis alone and with an antibody-stratified adjunct. The index classifications will be compared with an expert-adjudicated reference-standard diagnosis. No experimental treatment is assigned by the study. All diagnostic tests and treatments are determined by the treating clinicians according to routine clinical care. Study data are collected using a structured protocol-defined case report form.",[28,32,67],"Visual Loss",[69,70,71,72,73],"2022 International Criteria for Optic Neuritis","Diagnostic accuracy","Antibody-stratified adjunct","Aquaporin-4 immunoglobulin G","Myelin oligodendrocyte glycoprotein immunoglobulin G","2026-06-11",{"date":76,"type":45},"2026-06-15",{"date":78,"type":45},"2025-01-06",{"date":80,"type":22},"2028-01",{"name":82,"class":83},"First Affiliated Hospital of Guangxi Medical University","OTHER",9,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":114},"100600707","phase-3-treatment-of-inflammatory-myelitis-and-optic-neuritis-with-early-vs-rescue-plasma-exchange-timely-plex-100600707","NCT07100990","Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)","A Randomized Controlled, Open-Label, Rater-Blinded Pragmatic Trial, Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)","TIMELY-PLEX","Study Population and Setting\n\nThe proposal will recruit participants presenting to participating sites with severe ON or severe TM to two separate sub-trials. The detailed inclusion and exclusion criteria for each sub-trial are listed below:\n\nOptic Neuritis Sub-Trial:\n\nInclusion criteria:\n\n* ≥18 years of age\n* MRI orbits demonstrating evidence of new T2 hyperintensity and\u002For post-gadolinium contrast enhancement of the optic nerve(s) and meeting the clinical criteria for Optic Neuritis\n* Visual acuity 20\u002F200 or worse\n* Within 8 days of onset of visual symptoms\n* Able to initiate PLEX within 72h of the first dose of HDCS (if randomized to the \"Early PLEX\" treatment arm)\n* Able to sign and date informed consent form\n* Willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion criteria:\n\n* Evidence of prior episode of optic neuritis in the affected eye (by history or ophthalmological evaluation)\n* Ophthalmological comorbidity that would significantly affect best corrected visual acuity or visual fields\n* Pregnancy\n* Presence of any contraindication to receiving HDCS or PLEX, including, but not limited to, hemodynamic instability, significant bleeding\u002Fcoagulopathy, or sepsis.\n* Any medical condition that, in the opinion of the investigator, may interfere with the patient's participation in the trial, pose any added risk for the patient, or confound the assessment of the patient (including but not limited to concurrent neurological disease and\u002For medical comorbidity)\n* Treatment with any investigational agent within 6 months of baseline or five half-lives of the investigational agent (whichever is longer)\n* Ongoing\u002Fprior treatment with immune-modulating\u002Fimmunosuppressive therapy including:\n\n  * Mycophenolate mofetil, azathioprine, methotrexate, fingolimod, siponimod, ponesimod, ozanimod, tocilizumab, satralizumab, eculizumab or ravulizumab within 3 months of randomization\n  * Anti-CD20 (rituximab, ocrelizumab, ofatumumab, ublituximab) or anti-CD19 (inebilizumab) therapy within 6 months of randomization\n  * Intravenous or subcutaneous immune globulin within 3 months of randomization\n  * Plasma exchange within 3 months of randomization\n  * Interferon-beta, glatiramer acetate, fumarates (dimethyl fumarate, monomethyl fumarate, diroximel fumarate) within 1 month of randomization\n  * Teriflunomide use within prior 24 months\n  * Systemic corticosteroid therapy (intravenous or oral; excluding inhaled or topical corticosteroids) within 1 month of randomization\n  * Any previous treatment with alemtuzumab, cladribine, mitoxantrone or cyclophosphamide\n* Previous treatment with any immune-modulating or immunosuppressive therapy not mentioned above within 6 months of randomization or five-half-lives (whichever is longer)\n\nTransverse Myelitis Sub-Trial:\n\nInclusion criteria:\n\n* ≥18 years of age\n* Diagnosis of Transverse Myelitis (defined based on modified criteria adapted from the 2002 Transverse Myelitis Consortium Working Group; ALL are required)\n\n  * Development of sensory, motor and\u002For autonomic symptomatology attributable to spinal cord dysfunction\n  * Onset of symptoms to nadir \\>12 hours\n  * Exclusion of extra-axial compressive etiology by neuroimaging\n  * Demonstration of inflammation within the spinal cord by presence of intramedullary T2 lesion (post-gadolinium enhancing OR non-enhancing) on MRI\n* Expanded Disability Status Scale \\[EDSS\\] ≥3.0 (excluding visual and cerebral functional systems)\n* EDSS Pyramidal Functional System Score ≥ 2\n* Within 8 days of onset of motor symptoms\n* Able to initiate PLEX within 48h of the first dose of HDCS (if randomized to the \"Early PLEX\" treatment arm)\n* Able to sign and date informed consent form\n* Willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion criteria:\n\n* Pre-existing ambulatory, motor, sensory, or bowel\u002Fbladder disability of any cause that could confound trial assessments\n* Fulfillment of possible, probable or definite spinal cord infarction diagnosis per proposed diagnostic criteria (Zalewski et al. JAMA Neurology 2018)\n* History of radiation to the spine\n* Pregnancy\n* High clinical suspicion for infectious etiology of myelitis (e.g., fever, rash or other findings)\n* Presence of any contraindication to receiving HDCS or PLEX, including, but not limited to, hemodynamic instability, significant bleeding\u002Fcoagulopathy, or sepsis.\n* Any medical condition that, in the opinion of the investigator, may interfere with the patient's participation in the trial, pose any added risk for the patient, or confound the assessment of the patient (including but not limited to concurrent neurological disease and\u002For medical comorbidity)\n* Treatment with any investigational agent within 24 weeks of baseline or five half-lives of the investigational agent (whichever is longer)\n\n  * Ongoing\u002Fprior treatment with immune-modulating\u002Fimmunosuppressive therapy including: Mycophenolate mofetil, azathioprine, methotrexate, fingolimod, siponimod, ponesimod, ozanimod, tocilizumab, satralizumab, eculizumab or ravulizumab within 3 months of randomization\n  * Anti-CD20 (rituximab, ocrelizumab, ofatumumab, ublituximab) or anti-CD19 (inebilizumab) therapy within 6 months of randomization\n  * Intravenous or subcutaneous immune globulin within 3 months of randomization\n  * Plasma exchange within 3 months of randomization\n  * Interferon-beta, glatiramer acetate, fumarates (dimethyl fumarate, monomethyl fumarate, diroximel fumarate) within 1 month of randomization\n  * Teriflunomide use within prior 24 months\n  * Systemic corticosteroid therapy (intravenous or oral; excluding inhaled or topical corticosteroids) within 1 month of randomization\n  * Any previous treatment with alemtuzumab, cladribine, mitoxantrone or cyclophosphamide\n* Previous treatment with any immune-modulating or immunosuppressive therapy not mentioned above within 6 months of randomization or five-half-lives (whichever is longer)",{"count":94,"type":22},382,[25],"The purpose of this research is to evaluate if early vs rescue Therapeutic Plasma Exchange (PLEX) treatment algorithm leads to better visual outcomes in severe Optic Neuritis and leads to better neurological disability outcomes in severe Transverse Myelitis.",[28,98,99],"Myelitis","Myelitis, Transverse",[101,102,103,104],"Plasma Exchange","Plasmapheresis","Apheresis","Pheresis","2026-04-29",{"date":107,"type":45},"2026-05-05",{"date":109,"type":45},"2025-07-11",{"date":111,"type":22},"2031-04-30",{"name":113,"class":83},"Mayo Clinic",31,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":23,"phases":126,"briefSummary":128,"conditions":129,"keywords":130,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":143},"100249100","phase-2-assessment-of-clemastine-fumarate-as-a-remyelinating-agent-in-acute-optic-neuritis-recover-100249100","NCT02521311","Assessment of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis (ReCOVER)","A Randomized, Double-Blind, Parallel-Group, Placebo Controlled Trial to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis","ReCOVER","Inclusion Criteria:\n\n* Patients diagnosed or suspected to have an acute demyelinating optic neuritis in at least one eye within 3 weeks from the onset of any visual symptom other than pain\n* Use of disease-modifying therapies is not a contraindication\n* Use of appropriate contraception during the period of trial (women)\n* Understand and sign the informed consent\n\nExclusion Criteria:\n\n* Other major ophthalmologic diseases \u002F concomitant ophthalmologic disorders (e.g. diabetes, macular degeneration, glaucoma, severe myopia, etc)\n* Disc hemorrhages in the qualifying eye\n* No light perception in qualifying eye\n* Simultaneous bilateral optic neuritis\n* Cotton wool spots in the qualifying eye\n* Macular star in the qualifying eye\n* History of significant cardiac conduction block\n* History of cancer\n* Suicidal ideation or behavior in 6 months prior to baseline\n* Pregnancy, breastfeeding or planning to become pregnant\n* Involved with other study protocols simultaneously without prior approval\n* Concomitant use of any other putative remyelinating therapy as determined by the investigator\n* Serum creatinine \\> 1.5 mg\u002FdL; aspartate transaminase (AST), alanine transaminase (ALT), or alkaline phosphatase \\> 2 times the upper limit of normal\n* History of drug or alcohol abuse within the past year\n* Untreated B12 deficiency (as determined by B12 serological assessments and metabolites including methylmalonic acid (MMA) and homocysteine) or untreated hypothyroidism\n* Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic, urologic, endocrinologic, neurologic, pulmonary, psychiatric, dermatologic, allergic, renal, or other major diseases that, in the PI's judgment, may affect the interpretation of study results or patient safety\n* History or presence of clinically significant medical illness or laboratory abnormality that, in the opinion of the investigator would preclude participation in the study.\n* Positive for NMO antibody discovered within the first 2 weeks after randomization.","55 Years",{"count":125,"type":22},90,[127],"PHASE2","The main purpose of this study is to assess clemastine as a remyelinating agent in patients with acute optic neuritis.The study will also evaluate the tolerability of clemastine, originally approved as first-generation antihistamine, in patients with optic neuritis. Study procedures will include assessments for evidence of remyelination in the anterior visual pathway and in the brain using electrophysiologic techniques and magnetic resonance imaging. If they are on one, patients in this study can remain on their standard disease modifying treatment during the course of the study. However, patients cannot participate in any other investigational new drug research study concurrently.",[28],[131,132,133],"multiple sclerosis","eye pain","vision loss","2026-03-09",{"date":136,"type":45},"2026-03-11",{"date":138,"type":45},"2017-02-28",{"date":140,"type":22},"2028-08",{"name":142,"class":83},"University of California, San Francisco",1,{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":23,"phases":154,"briefSummary":155,"conditions":156,"keywords":157,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":53},"100550946","phase-2-efgartigimod-for-the-treatment-of-acute-optic-neuritis-100550946","NCT06453694","Efgartigimod for the Treatment of Acute Optic Neuritis","A Pilot Randomized Trial of Efgartigimod Alfa for the Treatment of Incident Moderate to Severe Acute Optic Neuritis","PET-AON","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Adults aged 18 years or older\n4. Diagnosed with a first episode of optic neuritis, based on clinical presentation (i.e. typical features such as pain with eye movements, color vision changes, subacute presentation, and visual acuity loss) and confirmed by contrast enhancement or T2 hyperintensity of the optic nerve on MRI brain or orbits using a 1.5T MRI scanner or greater\n5. Onset of optic neuritis-related vision changes (does not include headache, eye pain, or pain with eye movements), as defined by decreased visual acuity, subjectively reported blurred vision, or optic nerve enhancement on MRI brain or orbits, within 10 days (inclusive) of enrollment. If optic neuritis is bilateral, then enrollment must occur within 10 days of vision changes in the first affected eye.\n6. Best-corrected high contrast visual acuity (HCVA) in the worse affected eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart of logMAR 0.48 (20\u002F60) or worse.\n7. For females of reproductive potential: negative urine or serum pregnancy test at screening or use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 8 weeks after the end of efgartigimod administration\n8. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner\n\nExclusion Criteria:\n\n1. Current pregnancy or lactation\n2. Known allergic reactions or intolerance to efgartigimod, methylprednisolone, prednisone, or gadolinium or any of their components\n3. Known diagnosis of optic neuropathy preceding the current episode of optic neuritis\n4. Evidence of a systemic disease other than MS, NMOSD, or MOGAD that might be associated with the optic neuritis\n5. Receiving systemic immunomodulatory or immunosuppressive therapy at the time of enrollment or planned receipt within 3 weeks of treatment. Initiation of immunotherapy more than 3 weeks after the second dose of efgartigimod is not an exclusion criterion and is permitted.\n6. Known diagnosis of CNS demyelinating disease (MS, NMOSD, MOGAD) prior to present attack.\n7. Any visually-significant ocular pathology (i.e. retinal problems, cataracts, glaucoma etc.) in the affected eye that led to known best-corrected visual acuity deficits in participants prior to onset of optic neuritis. Congenital color-blindness is not disqualifying.\n8. Alternative explanation for visual changes detected on fundoscopic exam and slit lamp examination.\n9. Enrollment in another clinical study involving an investigational treatment given within 2 months of enrollment in the present study.\n10. Contraindication to MRI or plasma exchange\n11. Has received \\>3 days of high-dose steroids (IV or PO) for the treatment of the current episode of acute optic neuritis by the time of randomization. Randomization may occur at the latest on the next day after completion of 3rd dose of steroids.\n12. Known HIV disease or common variable immunodeficiency\n13. History of malignancy unless considered cured by adequate treatment with no evidence of recurrence for ≥1 year before the first administration of IMP. Adequately treated participants with the following cancers may be included at any time:\n\n    1. Basal cell or squamous cell skin cancer\n    2. Carcinoma in situ of the cervix\n    3. Carcinoma in situ of the breast\n    4. Incidental histological finding of prostate cancer (TNM stage T1a or T1b)\n14. Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection\n15. Clinically significant recent major surgery (within 1 month of screening), or intends to have surgery during the study\n16. Any conditions or circumstances that in the opinion of the investigator may put the participant at undue risk, confound the results of the study, or otherwise make the participant unsuitable for the study.",{"count":153,"type":22},20,[127],"The goal of this pilot clinical trial is to test efgartigimod alfa against placebo in adults with first-time optic neuritis (optic nerve inflammation). The main questions it aims to answer are:\n\n* Is it feasible to use efgartigimod alfa for optic neuritis?\n* Is it feasible to run a larger trial testing efgartigimod alfa in optic neuritis?\n* Does efgartigimod alfa work better than placebo in improving how quickly and how much vision returns?\n\nParticipants will:\n\n* have their vision and blood tested\n* be asked questions about their vision\n* will receive standard of care treatment with steroids regardless of whether they are receiving efgartigimod alfa or not\n* will have periodic visits over 6 months",[28],[158,159,160,161,33],"Optic neuritis","Inflammatory optic neuropathy","Myelin Oligodendrocyte Glycoprotein Antibody Disease (MOGAD)","Neuromyelitis Optica Spectrum Disorder (NMOSD)","2025-11-06",{"date":164,"type":45},"2025-11-10",{"date":166,"type":45},"2025-08-12",{"date":168,"type":22},"2027-07",{"name":170,"class":83},"Anastasia Vishnevetsky, MD, MPH",{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":179,"enrollmentInfo":180,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":182,"conditions":183,"keywords":184,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":143},"100476749","visual-pathways-model-in-neuro-inflammatory-disorders-100476749","NCT05487989","VIsual Pathways Model in Neuro-inflammatory Disorders","Study of the VIsual Pathways MODEL for a Better Understanding of Neurodegeneration in Inflammatory and Demyelinating Disorders of Central Nervous System","VIP-MODEL","Inclusion Criteria:\n\n* \\- Male or female\n* Aged between 18 and 65 years\n* Presenting a clinical picture of optic neuritis for less than 4 weeks, confirmed by neuro-ophthalmological assessment\n* Patient having given written consent to participate in the study\n* Patient with social insurance\n* Patient willing to comply with all study procedures and duration\n\nExclusion Criteria:\n\n* \\- history of optic neuritis on the same side as the recent episode for which the patient is being treated\n* history of retinal pathology (retinal detachment, glaucoma, retinopathies, retinal surgery)\n* diabetes\n* chronic alcohol intoxication\n* contraindications to MRI\n* pregnant women\n* persons under protective supervision (ex : guardianship)\n* minors\n* persons deprived of their liberty\n* administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of social security coverage, refusal to sign consent\n\nA history of pre-existing CNS inflammatory demyelinating disease is not a criterion for non-inclusion.","65 Years",{"count":181,"type":22},100,"In neuroinflammatory diseases of the central nervous system (CNS) such as multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD) and anti-MOG antibody-associated disorders (MOGAD), neuronal degeneration is the consequence of inflammatory and demyelinating lesions in the brain, optic nerve and spinal cord. Both white and grey matter are systematically affected. Lesions of the perivascular spaces containing cerebrospinal fluid (CSF) and meningeal inflammation seem to play an important role in the pathophysiology of these neuroinflammatory diseases. Currently, the interrelation of all these aspects is not clearly established in the pathophysiology of these diseases. In order to better understand the mechanisms that lead to and underlie the clinical disability of patients with these diseases, we need in vivo study models that allow the in-depth study of the neurodegenerative process and the identification of its causes. In this perspective, we make the hypothesis that the visual pathways model is very relevant to measure neuro-axonal loss and to explore the different mechanisms involved in neurodegeneration during MS and other CNS demyelinating diseases. Researchers have at their disposal many tools that allow them to analyse and quantify the neurodegenerative process in a reproducible and very precise manner from a structural and functional point of view, while taking into account possible vascular involvement (MRI, optical coherence tomography - angiography, etc…).",[28],[158,185,186,187,188],"Optical coherence tomography, MRI, demyelination, neuro-axonal loss.","MRI","demyelination","neuro-axonal loss","2025-08-19",{"date":191,"type":45},"2025-08-20",{"date":193,"type":45},"2022-10-07",{"date":195,"type":22},"2028-04-07",{"name":197,"class":83},"University Hospital, Lille",{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":204,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":23,"phases":207,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":143},"100316614","retinal-neuro-vascular-coupling-in-patients-with-multiple-sclerosis-100316614","NCT03401879","Retinal Neuro-vascular Coupling in Patients With Multiple Sclerosis","Inclusion criteria for healthy subjects:\n\n* Men and women aged over 18 years\n* Non-smokers\n* Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant\n* Normal ophthalmic findings, ametropy \\\u003C 6 Dpt.\n\nInclusion criteria for patients with MS:\n\n* Men and women aged over 18 years\n* Diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to clinical evaluation and McDonald criteria (revision 2010)\n* History of AON in one eye at least one year ago\n* Non-smokers\n* Normal ophthalmic findings, ametropy \\\u003C 6 Dpt.\n* Adequate visual acuity to allow participation in the ocular blood flow measurements\n* A potential participant has to be on stable doses of all medications he\u002Fshe is taking because of consisting illnesses according to medical history (except MS therapy itself which will be recorded separately) for at least 30 days prior inclusion, if considered relevant by the investigator.\n\nAny of the following will exclude a healthy subject from the study:\n\n* Diagnosis of \"possible MS\" according to the McDonald criteria (revision 2010)\n* Presence or history of a severe medical condition as judged by the clinical investigator\n* Untreated Arterial hypertension\n* History or family history of epilepsy\n* Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator\n* Family history of MS, optic neuritis, neuromyelitis optica (NMO, Devic disease) or NMO spectrum disorders\n* History of inflammatory or infectious disease of central nervous system\n* Best corrected visual acuity \\\u003C 0.5 Snellen\n* Ametropy ≥ 6Dpt\n* Pregnancy or planned pregnancy\n* Alcoholism or substance abuse\n\nAny of the following will exclude a patient from the study:\n\n* Presence or history of a severe medical condition other than MS as judged by the clinical investigator\n* History of neuromyelitis optica (NMO, Devic disease) or NMO spectrum disorders\n* History of inflammatory or infectious disease of central nervous system other than MS\n* Untreated Arterial hypertension\n* History or family history of epilepsy\n* Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator\n* Best corrected visual acuity \\\u003C 0.5 Snellen\n* Ametropy ≥ 6 Dpt\n* Pregnancy, planned pregnancy\n* Significant neurological disease other than MS, if considered relevant by the investigator\n* Alcoholism or substance abuse",true,{"count":206,"type":22},50,[208],"NA","Multiple sclerosis (MS) affects approximately 2.3 million patients worldwide, with a global median prevalence of 33 per 100,000. MS is diagnosed at an average of 30 years and affects twice as many women as men. MS is traditionally diagnosed by the presentation of lesions of the central nervous system, disseminated in time and in space, proven by clinical examination and magnetic resonance imaging. Several anatomical parameters in the eye, both vascular and neural, have been found to be altered in MS patients.\n\nBecause of its unique optical properties, the eye offers the possibility of the non-invasive assessment of both structural and functional alterations in neuronal tissue. As the neuro-retina is part of the brain, it does not come as a surprise that neuro-degenerative changes in the brain are accompanied by structural and possibly also functional changes in the neuro-retina and the ocular vasculature.\n\nThe current study seeks to test the hypothesis that beside the known anatomical changes, also functional changes can be detected in the retina of patients with MS. For this purpose, flicker light induced hyperemia will be measured in the retina as a functional test to assess the coupling between neural activity and blood flow. Further, structural parameters such as retinal nerve fiber layer thickness and function parameters such as ocular blood flow and retinal oxygenation will be assessed and compared to age and sex matched controls.",[211,28],"Multiple Sclerosis, Relapsing-Remitting","2025-05-20",{"date":214,"type":45},"2025-05-23",{"date":216,"type":45},"2018-02-01",{"date":218,"type":22},"2026-03",{"name":220,"class":83},"Medical University of Vienna",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":231,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":4},"100586500","evaluation-of-optic-neuritis-using-synthetic-quantitative-mri-100586500","NCT06916182","Evaluation of Optic Neuritis Using Synthetic Quantitative MRI","QUESTION","Inclusion Criteria:\n\n* Presenting with a painful unilateral decrease in visual acuity for less than one month\n* Referred for contrast-enhanced MRI imaging\n* Explicit consent for participation in the study\n\nExclusion Criteria:\n\n* Ophthalmological diagnosis other than optic neuritis explaining the symptoms\n* Known history of optic neuritis (same eye or contralateral eye)\n* Ophthalmological history interfering with the interpretation of ophthalmologic examinations (severe myopia, retinopathy)\n* Known glaucoma (same eye or contralateral eye)\n* Known diabetes\n* Patient under legal protection\n* Pregnant or breastfeeding woman",{"count":181,"type":22},"Inflammatory optic neuropathy (optic neuritis) is an acute condition that can affect the optic nerve along its entire course.\n\nIt is a rare event, with a prevalence of up to 5 cases per 100,000 people per year, predominantly affecting young individuals (18-50 years old), primarily Caucasian and female. The causes of optic neuropathy are diverse, with the most common being multiple sclerosis, which is the revealing condition in nearly 30% of cases.\n\nMRI is an integral part of the initial assessment of optic neuritis, in conjunction with clinical examination, laboratory tests, and OCT (optical coherence tomography). It plays a crucial role in the acute management of this condition, particularly by guiding the etiological diagnosis and helping adapt the therapeutic approach accordingly.\n\nThe establishment of objective and reliable MRI prognostic markers could allow for more precise immediate therapeutic adjustments, thereby improving the prognosis of this potentially severe and debilitating disease, whose treatment itself is not without risks. Indeed, determining the appropriate corticosteroid dose and deciding whether to combine it with other treatments remains a current clinical challenge.\n\nDespite various publications, MRI prognostic criteria for short- and long-term outcomes of optic neuritis remain unclear. Recent studies using radiomics have shown promising results, but these rely on limited sample sizes. New investigative methods are currently under development in the field of medical imaging, particularly \"quantitative MRI.\"\n\nThis approach enables effective analysis through mapping techniques, which generate numerical values compared to predetermined references. For instance:\n\nT1 (or R1) mapping assesses fibrosis and, indirectly, myelination, T2 (or R2) mapping evaluates edema. To our knowledge, this approach has never been studied for the optic nerve.\n\nMore recently, the emergence of synthetic imaging has made it possible to generate the previously mentioned R1\u002FR2 maps, along with more conventional weighted images (T1, T2, FLAIR, DP), from a single MRI sequence (2D spin-echo sequence). This sequence provides quantitative values while maintaining a short acquisition time (\\~5 minutes), which is essential in ophthalmologic imaging, where motion artifacts are frequent.\n\nThe goal of this study is to identify prognostic criteria for the evolution of optic neuritis using synthetic quantitative MRI sequences, in the form of threshold numerical values.",[28],"NOT_YET_RECRUITING","2025-03-31",{"date":234,"type":45},"2025-04-08",{"date":236,"type":22},"2025-06",{"date":238,"type":22},"2027-11",{"name":240,"class":241},"Fondation Ophtalmologique Adolphe de Rothschild","NETWORK",{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":248,"enrollmentInfo":249,"targetDuration":4,"studyType":23,"phases":250,"briefSummary":251,"conditions":252,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":143},"100480767","edaravone-in-the-treatment-of-optic-neuritis-100480767","NCT05540262","Edaravone in the Treatment of Optic Neuritis","Inclusion Criteria:\n\n1. Chinese patients aged ≥18 with anti-aquaporin-4 antibody-positive optic neuritis\n2. Patients with a first episode of optic neuritis in either eye\n3. First symptoms of optic neuritis ≤30 days prior to the first administration of edaravone\n\nExclusion Criteria:\n\n1. Myopia over 6 diopters\n2. Refractive media opacity affecting assessment of retinal layers and\u002For visual acuity","70 Years",{"count":206,"type":22},[208],"Edaravone has demonstrated a beneficial effect in promoting remyelination and protecting axons in animals with NMOSD. The researchers posit that edaravone may enhance visual outcomes in patients with aquaporin-4 antibody-positive optic neuritis.",[28],"2025-02-25",{"date":255,"type":45},"2025-02-27",{"date":257,"type":45},"2022-01-15",{"date":259,"type":22},"2025-12-31",{"name":82,"class":83},{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":268,"enrollmentInfo":269,"targetDuration":18,"studyType":64,"phases":4,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":297},"100440580","swiss-pediatric-inflammatory-brain-disease-registry-swiss-ped-ibraind-100440580","NCT05017142","Swiss Pediatric Inflammatory Brain Disease Registry (Swiss-Ped-IBrainD)","Swiss Pediatric Inflammatory Bain Disease Cohort Study","Inclusion Criteria:\n\nAll patients living and\u002For treated in Switzerland with an IBrainD specified in the following list diagnosed from 2005 onward and with a disease onset before the age of 18.\n\n* Written informed consent by patients (and\u002For legal representative(s), if applicable)\n* Optic Neuritis\n* Transverse Myelitis\n* Acute disseminated encephalomyelitis\n* Multiple Sclerosis\n* Neuromyelitis Optica Spectrum Disorders\n* Myelin oligodendrocyte glycoprotein antibody-associated disease\n* Anti-NMDA-R Encephalitis\n* Anti-GAD65 Associated Autoimmune Encephalitis\n* Anti-AMPAR-1\u002F2 Associated Autoimmune Encephalitis\n* Anti-Lgi-1 Associated Autoimmune Encephalitis\n* Anti-CASPR-2 Associated Autoimmune Encephalitis\n* Anti-GABAR-1\u002F2 Associated Autoimmune Encephalitis\n* Onconeuronal Antibody (Hu, Ri, Yo, Amphiphysin, CRMP-5, Ma-1, Ma-2, SOX-1) Associated Autoimmune Encephalitis\n* Hashimoto Encephalopathy\n* CNS Vasculitis\n* CNS Sarcoidosis\n* CNS Lupus\n* Rasmussen Encephalitis\n\nExclusion Criteria:\n\n* Neurological symptoms due to infectious diseases of the CNS\n* Genetic\u002Fmetabolic causes of central demyelinating diseases\n* Neurological symptoms due to Guillain-Barré-Syndrome","36 Years",{"count":63,"type":22},"The Swiss-Ped-IBrainD is a national patient registry that collects information on diagnosis, symptoms, treatment, and follow-up of pediatric patients with an inflammatory brain disease in Switzerland. It was first implemented in 2020 in the pediatric clinic of the university hospital in Bern. Further centers all over Switzerland opened for recruitment after that: Aarau, Basel, Bellinzona, Chur, Geneva, Lausanne, Lucerne, St. Gallen, Winterthur and Zurich. The center in Fribourg is expected open for recruitment in 2025. The registry provides data for national and international monitoring and research. It supports research on inflammatory brain diseases in Switzerland and the exchange of knowledge between clinicians, researchers, and therapists. The registry aims to improve the treatment of children with inflammatory brain diseases and optimizing their health care and quality of life.",[28,272,273,33,274,275,276,277,278,279,280,281,282,283,284,285,286,287],"Transverse Myelitis","Acute Disseminated Encephalomyelitis","Neuromyelitis Optica Spectrum Disorder","Anti-NMDAR Encephalitis","Anti-GAD65 Associated Autoimmune Encephalitis","Anti-AMPAR-1\u002F2 Associated Autoimmune Encephalitis","Anti-Lgi-1 Associated Autoimmune Encephalitis","Anti-CASPR-2 Associated Autoimmune Encephalitis","Anti-GABAR-1\u002F2 Associated Autoimmune Encephalitis","Onconeuronal Antibody (Hu, Ri, Yo, Amphiphysin, CRMP-5, Ma-1, Ma-2, SOX-1) Associated Autoimmune Encephalitis","Hashimoto Encephalitis","CNS Vasculitis","CNS Sarcoidosis","CNS Lupus","Rasmussen Encephalitis","Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)","2024-12-11",{"date":290,"type":45},"2024-12-16",{"date":292,"type":45},"2020-04-14",{"date":294,"type":22},"2071-01-01",{"name":296,"class":83},"University of Bern",13,{"id":299,"slug":300,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":204,"sex":17,"minAge":18,"maxAge":306,"enrollmentInfo":307,"targetDuration":4,"studyType":23,"phases":308,"briefSummary":309,"conditions":310,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":143},"100546056","light-stimulation-to-improve-visual-function-after-optic-neuritis-in-persons-with-multiple-sclerosis-100546056","NCT06389968","Light Stimulation to Improve Visual Function After Optic Neuritis in Persons with Multiple Sclerosis","Lichtstimulation Zur Verbesserung Der Sehleistung Bei Patientinnen Und Patienten Mit Multipler Sklerose Nach Sehnerventzündung","ONSTIM","Inclusion Criteria:\n\n* Relapsing remitting multiple sclerosis or clinically isolated syndrome or no indication of chronic inflammatory central nervous system disease\n* Age 18-60 years\n* Optic neuritis within 1-3 months\n\nExclusion Criteria:\n\n* Epilepsy\n* Light-triggered migraine\n* Insufficient vision correction\n* Retinal disease (glaucoma, macular edema, macula degeneration, ...)","60 Years",{"count":206,"type":22},[208],"The aim of this monocentric randomized controlled intervention study is to improve visual function in persons with multiple sclerosis following optic neuritis (neuritis nervi optici) by means of a light stimulation.\n\nIn the treatment arm, two 80-second light stimulations are to be administered daily for 12 days in 25 persons with multiple sclerosis following recent optic neuritis (1-3 months). For the standardized application of light stimulation in the sense of standardized training, the light stimulation is to be carried out by watching a generated flicker video on a mobile phone. In a sham-intervened control group (sample size 25), the spontaneous course after optic neuritis will be recorded in parallel. Intensive neuronal stimulation of the visual pathway will be used to stimulate regenerative processes, which will be recorded by means of changes in high-contrast visual acuity (primary endpoint). Secondary endpoints are changes in a colored-contrast test, in 2.5% low contrast visual acuity, the peak conduction latency of visual evoked potentials, and retinal layer thicknesses and vessel densities measured in optical coherence tomography and optical coherence tomorgraphic angiography. These physiological parameters should help to understand the underlying processes of a potentially altered visual performance.",[211,28],"2024-11-20",{"date":313,"type":45},"2024-11-22",{"date":315,"type":45},"2024-08-01",{"date":317,"type":22},"2026-12-31",{"name":319,"class":83},"Technical University of Munich"]