[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ocular-myasthenia-gravis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ocular-myasthenia-gravis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,67,94],{"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":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100628583","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-rozanolixizumab-in-adult-participants-with-ocular-myasthenia-gravis-100628583",false,"NCT07463521","A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis","MyVision","Inclusion Criteria:\n\n* Participant must be a minimum of 18 years of age inclusive at the time of signing the informed consent form (ICF)\n* Participant has Myasthenia Gravis Foundation of America (MGFA) Class I with any ocular weakness at Screening through Baseline. The participant may have weakness in muscles of eye (ie, extraocular muscles that move the eyeball, including the medial rectus, lateral rectus, superior rectus, inferior rectus, superior oblique, and inferior oblique, orbicularis oculi muscles, and levator palpebrae superioris) but must have normal strength in all other facial, bulbar, and limb muscles.\n* Study participant has been diagnosed with Ocular Myasthenia Gravis (oMG) with consistent ocular clinical features at Screening and supported by:\n* Documented presence of autoantibodies against acetylcholine receptor (AChR) or muscle-specific kinase (MuSK), OR\n* Documented absence of autoantibodies against AChR or MuSK; in this case, documented abnormal repetitive nerve stimulation (RNS) or single fiber electromyography (SFEMG) (as defined in the adjudication manual) and at least 1 of the following should be met:\n\n  * Documented positive ice test (Ptosis recovers with the ice test \\[applied 2 minutes (min) to the ptotic lid\\] with \\>2mm improvement)\n  * History of positive edrophonium chloride (Tensilon) test (or equivalent tests used to establish oMG diagnostic as per current practice)\n  * Demonstrated objective improvement in oMG signs with acetylcholinesterase inhibitor (AChEIs), plasma exchange (PLEX), intravenous immunoglobulin (IVIg), subcutaneous immunoglobulin (SCIg) or corticosteroids (CSs)\n* Participant has an Myasthenia Gravis Impairment Index (MGII) ocular score (Patient-Reported Outcome (PRO) part) ≥6 with at least 2 ocular items with a score of ≥2 at both Screening and Baseline visits.\n* Participant reported ocular symptom(s) onset \\\u003C3 years before Screening or ≥3 years provided they have demonstrated response (ie, improvement in ptosis or diploplia) to treatment (IVIg, PLEX, SCIg, pyridostigmine, and\u002For CSs) in the past year.\n* Participant has no pupillary abnormality except those resulting from prior localized eye disease or surgical intervention.\n* Participant who:\n\n  * is currently receiving background treatment for oMG symptoms at the time of Screening and has been receiving treatment for oMG with a stable dose for at least 30 days prior to Screening, OR\n  * is not receiving any background treatment at the time of Screening\n* Participant has a body weight ≥35kg at Baseline.\n\nExclusion Criteria:\n\n* Participant has any clinically significant medical or psychiatric condition (including an alcohol or drug use disorder), recent major surgery (including thymectomy \\[within 3 months of Screening\\], solid organ, stem cell or marrow transplant), planned major surgery (including thymectomy) during study participation, and\u002For significant laboratory abnormality that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study.\n* Participant has been diagnosed with other diseases that lead to eyelid dropping, peripheral muscle weakness, or diplopia, including other autoimmune diseases that would interfere with an accurate assessment of the oMG clinical symptoms or other neurological diseases, such as congenital myasthenic syndromes, mitochondrial diseases, and muscular dystrophies.\n* Participant has a known hypersensitivity to other anti-Fc receptor (FcRn) medications, to any components of the study medication (including the excipient polysorbate 80) or has a known history of hyperprolinemia, since L-proline is a constituent of the rozanolixizumab formulation.\n* Participant has active neoplastic disease or has received treatment for neoplastic disease within 5 years of study entry (except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the uterine cervix, carcinoma in situ of the breast, or incidental histological findings of prostate cancer \\[Tumor, Node, Metastasis (TNM) stage T1a or T1b\\] that has been definitely treated with standard of care approaches).\n* Participant has a clinically relevant active infection (eg, tuberculosis (TB) infection) or a history of serious infection (resulting in hospitalization or requiring intravenous (iv) antibiotic treatment) within 6 weeks before the Baseline Visit.\n* Participant has renal impairment, defined as glomerular filtration rate less than 30milliliter\u002Fmin\u002F1.73m2 at Screening.\n* Participant has been previously treated with FcRn inhibitors.\n* Participant has been treated with any of the immunosuppressive medications, biologics, or other therapies, in the specified prohibitive timeframe.","ALL","18 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of the study is to demonstrate the efficacy, safety and tolerability of rozanolixizumab compared with placebo in the treatment of adult study participants with Ocular Myasthenia Gravis.",[27],"Ocular Myasthenia Gravis",[27,29,30],"Phase 3","rozanolixizumab","RECRUITING","2026-06-12",{"date":34,"type":35},"2026-06-16","ACTUAL",{"date":37,"type":35},"2026-05-27",{"date":39,"type":21},"2029-01-22",{"name":41,"class":42},"UCB Biopharma SRL","INDUSTRY",2,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100628718","phase-3-a-study-to-evaluate-the-long-term-safety-and-efficacy-of-rozanolixizumab-in-adult-participants-with-ocular-myasthenia-gravis-100628718","NCT07465289","A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis","A Phase 3, Open-Label, Extension Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis","Inclusion Criteria:\n\n* Participant must be a minimum of 18 years of age inclusive at the time of signing the informed consent form (ICF)\n* Participant must have received at least 1 dose of investigational medicinal product (IMP) (rozanolixizumab or placebo) in MG0038\n* Participant for whom the investigator considers a favorable benefit\u002Frisk for participation\n* Participant who, alone or with assistance of the caregiver, is considered reliable and capable of adhering to the protocol visit schedule or medication intake according to the judgement of the investigator\n* Male or female\n* A female participant is eligible to participate if she is not, not breastfeeding (including pumping breastmilk to feed a child), and at least 1 of the following conditions applies:\n\n  * Not a woman of childbearing potential (WOCBP)\n  * OR\n  * A WOCBP who agrees to follow the contraceptive guidance for the entire study period\n* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol\n\nExclusion Criteria:\n\n* Participant meets any of the withdrawal criteria defined in MG0038\n* Participant has a clinically relevant active infection (resulting in hospitalization or requiring intravenous (IV) antibiotic treatment) within 6 weeks before study entry.\n* Participant intends to have a live vaccination during the study or within 8 weeks following the final dose of rozanolixizumab\n* Participant has been administered with the prohibited immunosuppressive medications, biologics, or other therapies\n* Participant has planned use of prohibited medications",{"count":52,"type":21},100,[24],"The purpose of the study is to assess the long-term safety and efficacy of rozanolixizumab in adult study participants with ocular myasthenia gravis.",[27],[29,57,30],"oMG","NOT_YET_RECRUITING","2026-03-06",{"date":61,"type":35},"2026-03-11",{"date":63,"type":21},"2026-07-27",{"date":65,"type":21},"2031-01-23",{"name":41,"class":42},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":74,"enrollmentInfo":75,"targetDuration":77,"studyType":78,"phases":4,"briefSummary":79,"conditions":80,"keywords":81,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":93},"100376550","therapeutic-effect-of-different-immunosuppressants-on-non-thymoma-ocular-myasthenia-gravis-a-real-world-study-100376550","NCT04182984","TheRapeutic Effect of Different immunosuppressAnts on Non-Thymoma Ocular Myasthenia Gravis: a Real-world Study","TREAT-OMG","Inclusion Criteria:\n\n1. Age \\>18 years and\\\u003C75 years;\n2. Clinical Diagnosis of MG with supporting evidence:\n\n   Patients with ocular muscle type MG who have never received treatment meet one of the diagnoses (1) and (2)-(5): (1) The patient's symptoms involve the extraocular muscles, except for drooping eyelids and diplopia, no other clinical symptoms; (2) unequivocal clinical response to pyridostigmine; (3) positive acetylcholine receptor antibody or musk antibody; (4) decrement of more than 10% in repetitive nerve stimulations study (RNS); (5) the \"trembling\" of the single fiber electromyography (SFEMG) is broadened with or without blockade;\n3. Willingness to sample collection, imaging study and other disease-related examinations and assessments;\n4. The results of pregnancy tests for female subjects with fertility during the screening period should be negative and effective contraception was used by the patient and her spouse during the study period;\n5. Patients with informed consent;\n6. Predicted survival time is longer than 3 years.\n\nExclusion Criteria:\n\n1. History of chronic degenerative, psychiatric, or neurologic disorder other than MG that can produce weakness or fatigue;\n2. Patients who may have other diseases that may lead to eyelid drooping, peripheral muscle weakness or diplopia;\n3. Age ≤18 years or ≥75 years;\n4. Patients who have been taking glucocorticoids or associated immunosuppressants due to other immune system diseases;\n5. Patients who cannot use immunosuppressants due to other chronic diseases;\n6. Patients who are unable to cooperate with follow-up and self-assessment due to severe mental illness or cognitive impairment;\n7. Pregnant women, lactating women and patients with fertility plans during the trial;\n8. Patients who have suffered from severe infections or malignant tumors in the last 1 month and are unable to receive immunosuppressants treatments;\n9. Patients who are not willing to cooperate with repeated frequency electrical stimulation tests and chest CT examinations;\n10. Patients who are not willing to participate in this study;\n11. Patients who are unable to sign informed consent;\n12. Predicted survival time is shorter than 3 years;\n13. Patients who are not suitable to participated in the trial after researchers' assessment.","75 Years",{"count":76,"type":21},200,"3 Years","OBSERVATIONAL","This study collects the clinical data of new-onset ocular myasthenia gravis (OMG) patients, assesses outcomes and adverse effects of different treatment options, and evaluate risk factors of conversion to generalized MG(GMG).",[27],[82],"Ocular myasthenia gravis","2026-01-28",{"date":85,"type":35},"2026-01-30",{"date":87,"type":35},"2019-11-04",{"date":89,"type":21},"2026-06-30",{"name":91,"class":92},"Tang-Du Hospital","OTHER",1,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":116},"100542413","phase-3-immediate-corticosteroid-therapy-and-rituximab-to-prevent-generalization-in-ocular-myasthenia-a-probe-multicenter-open-label-randomized-controlled-trial-100542413","NCT06342544","Immediate Corticosteroid Therapy and Rituximab to Prevent Generalization in Ocular Myasthenia: a PROBE Multicenter Open-label Randomized Controlled Trial.","IMCOMG","Inclusion Criteria:\n\n* Patients over 18 years of age\n* Diagnosis of ocular myasthenia within the last 6 months, defined :\n\n  * either by a typical clinical examination objectified by an expert clinician: ptosis and\u002For binocular diplopia, with a variable and fluctuating character (either spontaneous or provoked by effort or rest)\n  * or by positive anti-AChR antibodies or the presence of decrement on repetitive nerve stimulation or a positive edrophonium test\n* Ocular symptoms lasting at least one month and limited to extra-ocular muscles (weakness in one or both orbicularis oculi)\n* No non-ocular symptoms on MMS, MGC and MG-ADL.\n* Naïve to immunosuppressive therapy for ocular myasthenia gravis.\n\nExclusion Criteria:\n\n* Thymoma\n* Pupillary anomaly other than that resulting from previous local disease or surgery.\n* Signs of restrictive abduction or supraduction myopathy due to dysthyroid ophthalmopathy.\n* Graves' ophthalmopathy\n* Onset of ocular symptoms more than one year before screening date\n* Hypersensitivity to rituximab, murine proteins, prednisone, methylprednisone, aziathioprine or 6-mercaptopurine, paracetamol, dexchlorpheniramine.\n* Any infectious condition\n* Patients with severe immune deficiency\n* Severe heart failure (New York Heart Association (NYHA) Class IV) or severe uncontrolled heart disease\n* Severe hepatic insufficiency\n* Psychotic states not yet controlled by treatment\n* Hyperuricemia on xanthine oxidase inhibitors (allopurinol and febuxostat)\n* Risk of angle-closure glaucoma\n* Risk of urinary retention due to urethro-prostatic disorders\n* Vaccination with live attenuated vaccine required during study and up to 6 months after rituximab discontinuation\n* Women of childbearing age who do not wish to use effective contraception during their participation and at least 12 months after\n* Pregnant or breast-feeding women",{"count":102,"type":21},128,[24],"Myasthenia is an autoimmune disease causing dysfunction of the neuromuscular junction, resulting in fluctuating and variable muscle weakness.\n\nIn the initial phase of the disease, 70% of patients present with ocular onset myasthenia (OMG), i.e. weakness limited to the oculomotor muscles. Generalization to skeletal, bulbar and axial muscles occurs in 20-40% of cases, with a higher frequency in the first and second years, respectively 46% and 60% of generalizations. This reflects the maturation of the autoimmune response in the early years of the disease, and represents a therapeutic window of opportunity to modify the course of the disease.\n\nGeneralization is a critical event, putting the patient at risk of admission to an intensive care unit and necessitating the use of long-term immunosuppressants.\n\nThere is currently no validated strategy for preventing generalization. On the one hand, a preventive role for corticosteroid therapy in ocular-onset myasthenia has been observed in some studies, but not confirmed by others. These contradictory results may be explained by the bias of retrospective observational studies and the use of different corticosteroid administration regimens.\n\nOn the other hand, recent data on the use of low-dose Rituximab in the early phase of the disease shows greater efficacy than later use, enabling prolonged remission of the disease with a very good tolerability profile.\n\nWe propose to compare in a randomized controlled trial the usual practice with a proactive strategy with a standardized corticosteroid regimen immediate at diagnosis.\n\nPatients with ocular myasthenia are usually treated symptomatically with acetylcholinesterase inhibitors. The introduction of corticosteroids is delayed and limited to patients with persistent disabling diplopia or ptosis with occlusion. When corticosteroids are tapered off, ocular symptoms may recur. This level of corticosteroid dependence observed in patients treated for ocular myasthenia has not been specifically studied. In order to reduce the levels of corticosteroids administered and avoid recurrence of ocular symptoms and their delayed generalization, it is usually proposed to introduce another immunosuppressant.\n\nThe aim of this study is to evaluate the efficacy of a standardized proactive prevention strategy on the generalization of ocular onset myasthenias during the first 2 years. It will combine immediate treatment with corticosteroids at the time of diagnosis, with the addition of rituximab in the event of recurrence of ocular symptoms as corticosteroids are tapered off.",[27],"2026-01-19",{"date":108,"type":35},"2026-01-21",{"date":110,"type":35},"2025-04-29",{"date":112,"type":21},"2029-06",{"name":114,"class":115},"Fondation Ophtalmologique Adolphe de Rothschild","NETWORK",11]