[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"optic-neuropathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:optic-neuropathy":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,90,121,154,176,197,223],{"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":4,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":120},"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":20,"type":21},"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.",[102,31,103],"Optic Neuritis","Visual Loss",[105,106,107,108,109],"2022 International Criteria for Optic Neuritis","Diagnostic accuracy","Antibody-stratified adjunct","Aquaporin-4 immunoglobulin G","Myelin oligodendrocyte glycoprotein immunoglobulin G","2026-06-11",{"date":112,"type":81},"2026-06-15",{"date":114,"type":81},"2025-01-06",{"date":116,"type":21},"2028-01",{"name":118,"class":119},"First Affiliated Hospital of Guangxi Medical University","OTHER",9,{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":131,"briefSummary":133,"conditions":134,"keywords":137,"overallStatus":143,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":153},"100637519","phase-2-teprotumumab-n01-versus-methylprednisolone-after-urgent-orbital-decompression-for-dysthyroid-optic-neuropathy-100637519","NCT07594912","Teprotumumab N01 Versus Methylprednisolone After Urgent Orbital Decompression for Dysthyroid Optic Neuropathy","A Single-Center, Prospective, Randomized, Open-Label, Parallel-Group Study Comparing Sequential Teprotumumab N01 With Intravenous Methylprednisolone After Urgent Orbital Decompression in Patients With Dysthyroid Optic Neuropathy","Inclusion Criteria:\n\n* Able and willing to provide written informed consent.\n* Age 18 to 65 years.\n* Clinical diagnosis of thyroid eye disease (TED) with dysthyroid optic neuropathy (DON). Diagnosis of DON must meet both of the following criteria:\n\n  1. Visual dysfunction not explained by other causes, such as decreased best-corrected visual acuity, visual field defect, abnormal color vision, or relative afferent pupillary defect.\n  2. Imaging evidence of orbital apex crowding, optic nerve compression, or optic nerve stretching.\n* The study eye meets the criteria for urgent orbital decompression, defined as either of the following:\n\n  1. Poor response after rescue intravenous methylprednisolone for the current dysthyroid optic neuropathy episode, with a cumulative methylprednisolone-equivalent dose of no more than 3.0 g, defined as no improvement or continued deterioration of visual function within 1 to 2 weeks.\n  2. Contraindication to glucocorticoids or investigator judgment that direct urgent mechanical decompression is required.\n* Thyroid function is normal or mildly abnormal before enrollment, with free triiodothyronine (FT3) and free thyroxine (FT4) within 50% above or below the normal reference range when possible.\n* Alanine aminotransferase (ALT) no more than 1.5 times the upper limit of normal, aspartate aminotransferase (AST) no more than 3 times the upper limit of normal, and serum creatinine no more than 1.5 times the upper limit of normal.\n* For participants with diabetes mellitus, hemoglobin A1c (HbA1c) less than 9.0% and stable antidiabetic treatment within 60 days before enrollment.\n* For women of childbearing potential, a pregnancy test must be negative before enrollment.\n* Participants of reproductive potential agree to use effective contraception during the study and for 90 days after the last dose of study treatment.\n* Able and willing to comply with study treatment and follow-up procedures.\n\nExclusion Criteria:\n\n* Orbital decompression surgery within 6 months before screening.\n* Bilateral dysthyroid optic neuropathy requiring urgent bilateral orbital decompression at baseline.\n* Cumulative preoperative methylprednisolone-equivalent dose greater than 3.0 g for the current dysthyroid optic neuropathy episode.\n* Systemic glucocorticoid treatment for non-thyroid eye disease within 3 months before screening with cumulative methylprednisolone-equivalent dose of 1.0 g or greater.\n* Tocilizumab or other systemic immunosuppressive treatment within 3 months before screening, or rituximab within 6 months before screening.\n* Orbital radiotherapy within 3 months before screening.\n* Previous treatment with teprotumumab.\n* Other ocular diseases that may significantly affect visual function assessment, including glaucomatous optic neuropathy, macular disease, severe cataract, or non-thyroid eye disease optic neuropathy.\n* Irreversible optic nerve damage in the study eye with very low potential for visual recovery, as judged by the investigator.\n* History of definite inner ear disease or clinically significant hearing impairment.\n* Severe cardiovascular disease.\n* Severe hepatic or renal disease.\n* Active infection or clinically significant infectious disease, including active hepatitis, HIV infection, syphilis, or active tuberculosis.\n* Active gastrointestinal ulcer.\n* Clinically significant abnormal blood test results, including white blood cell count less than 4.0 × 10\\^9\u002FL, platelet count less than 80 × 10\\^9\u002FL, hemoglobin less than 110 g\u002FL in males or less than 100 g\u002FL in females.\n* History of malignancy judged by the investigator to be unsuitable for enrollment.\n* Pregnancy or breastfeeding.\n* Known allergy to monoclonal antibodies, methylprednisolone, or any study drug excipient.\n* Uncontrolled diabetes mellitus or any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.","65 Years",{"count":130,"type":21},60,[132],"PHASE2","This study aims to evaluate the efficacy and safety of sequential Teprotumumab N01 compared with intravenous methylprednisolone (IVMP) after urgent orbital decompression in patients with dysthyroid optic neuropathy (DON).",[135,136,31],"Thyroid Eye Disease, TED","Graves Ophthalmopathy",[138,139,140,141,142],"Dysthyroid optic neuropathy","Orbital decompression","Teprotumumab N01","Intravenous methylprednisolone pulse","Thyroid eye disease","NOT_YET_RECRUITING","2026-05-17",{"date":146,"type":81},"2026-05-19",{"date":148,"type":21},"2026-08",{"date":150,"type":21},"2028-04",{"name":152,"class":119},"Sun Yat-sen University",1,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":161,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":164,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":153},"100566997","repetitive-transorbital-alternating-current-stimulation-for-optic-neuropathies-100566997","NCT06662448","Repetitive Transorbital Alternating Current Stimulation for Optic Neuropathies","An Open-Label Study to Evaluate the Efficacy and Feasibility of Home-Based Repetitive Transorbital Alternating Current Stimulation for Optic Neuropathies","Inclusion Criteria:\n\n1. Age equal to or over 18 years old\n2. Must have a permanent residence\n3. Diagnosis of optic neuropathy\n4. VF defects present in at least one eye (MD ≤ -3.00 dB) FL, FP, FN \\\u003C33%\n5. Visual Field Index (VFI) 10-90%\n6. Clear optical apparatus\n7. Best-corrected VA of 20\u002F400 or better in at least one eye\n8. Commitment to comply with study procedures: 8-week period of intervention sessions (30 sessions every other day), baseline visit, post-intervention visit, and 2 follow-up visits (2 days per visit).\n\n   1. Scheduling\n   2. Testing\n9. A subject deemed incapable of performing the study intervention independently due to visual impairment or any other condition that may prevent them from performing the intervention accurately require a family member or caregiver to assist in performing the intervention.\n\nExclusion Criteria:\n\n1. High intraocular pressure (over 27 mmHg)\n2. End-stage organ disease or medical condition with subsequent vision loss (e.g., diabetes, stroke)\n3. Advanced or unstable retinal diseases\n4. Pathological nystagmus\n5. Acute conjunctivitis\n6. Photosensitivity to flickering lights\n7. Non-ocular\u002Focular surgery within the previous 2 months to enrollment date\n8. Electric or electronic implants (e.g., cardiac pacemaker)\n9. Metallic artifacts\u002Fimplants in head and\u002For torso (titanium screw and dental implants are allowed)\n10. Diagnosed epilepsy on medical treatment\n11. Auto-immune disease, acute stage (e.g., rheumatoid arthritis)\n12. Metastatic disease\n13. Certain mental diseases\u002Fpsychiatric conditions (e.g., schizophrenia) that would affect the subject's ability to perform all necessary study tasks\n14. Any chronic unstable medical conditions (e.g., uncontrolled diabetes,) that may cause a subject to miss one or more of the interventions and visits\n15. Addiction (e.g., drug\u002Falcohol dependence) that has not been in abstinent control for at least one year\n16. Uncontrolled systemic hypertension (historical BP \\> 160\u002F100 mmHg)\n17. Pregnant or breast-feeding women or women that are planning to become pregnant, as this device has not been tested on pregnant women and there is no data on using rtACS for this particular group\n18. Any severe skin condition (e.g., blisters, open wounds, cuts or irritation) or other skin defect which compromise the integrity of the skin at or near stimulation locations\n19. IOP that the principal investigator determines that is not clinically stable\n20. Complete blindness of both eyes\n21. Non-resected brain tumors\n22. Unstable diabetic retinopathy in the study eye\n23. Optic neuropathies secondary to brain tumors\n24. Subjects without the capacity to consent",true,{"count":163,"type":21},70,[24],"The purpose of this study is to test the efficacy and feasibility of an intervention protocol for home-based repetitive transorbital alternating current stimulation (rtACS) for the treatment of visual impairment in people with optic neuropathy. The primary aims are to evaluate the effectiveness of home-based rtACS to ameliorate the progressive effects of vision loss functionally in the eye and the visual pathway, and in regard to people's independence (i.e., functional ability).",[31],"2026-02-26",{"date":169,"type":81},"2026-02-27",{"date":171,"type":81},"2024-11-18",{"date":173,"type":21},"2029-05-18",{"name":175,"class":119},"NYU Langone Health",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":22,"phases":185,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":153},"100525975","hyperbaric-oxygen-therapy-for-optic-neuropathies-100525975","NCT06128720","Hyperbaric Oxygen Therapy for Optic Neuropathies","A Randomized, Sham Controlled, Masked Phase II Study to Evaluate the Neuroprotective Effect of Hyperbaric Oxygen Therapy on Optic Neuropathy","HBOT","Inclusion Criteria:\n\n* Patients must meet all of the following criteria to join the study (all eligibility criteria must be met at the screening and baseline visits unless otherwise noted):\n* Participant must be at least 18.\n* Participant must has the ability to comply with the requirements of the study and complete the schedule of events (SOE).\n* Participant's with clinical evidence of optic neuropathy.\n* Participant must understand and sign the informed consent. If the participant's vision is impaired to the point where he\u002Fshe cannot read the informed consent document, the document will be read to the participant in its entirety.\n\nExclusion Criteria:\n\n* Participant is unable to comply with study procedures or follow-up visits.\n* Participant has evidence of corneal opacification or lack of optical clarity.\n* Participant is currently participating in or has within the last 3 months participated in any other clinical trial of a drug by ocular (if in the study eye) or systemic administration.\n* Participant is pregnant or lactating.\n* Participant has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations and outcome assessments.\n* Children and comatose patients.\n* Participant abusing drugs or alcohol.\n* Prior treatment with hyperbaric oxygen within the last 6 months.\n* Participant with claustrophobia or that cannot decompress properly.",{"count":130,"type":21},[24],"The purpose of the study is to evaluate the neuroprotective efficacy of hyperbaric oxygen for the treatment in patients with optic neuropathy.",[31,35],"2025-05-20",{"date":190,"type":81},"2025-05-25",{"date":192,"type":81},"2022-11-01",{"date":194,"type":21},"2027-12",{"name":196,"class":119},"Stanford University",{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":17,"minAge":204,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":22,"phases":207,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":143,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":153},"100554993","phase-1-clinical-study-of-fb1001-in-patients-100554993","NCT06506305","Clinical Study of FB1001 in Patients","A Single\u002FMultiple Dose Escalation, Open-Labeled, Phase I Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of FB1001 in Patients With Acute Optic Neuropathy","Inclusion Criteria:\n\n1. Patients with Acute Primary Angle-Closure Glaucoma (APACG) Optic Neuropathy：\n\n   1. Within 120 hours prior to the planned administration of the study drug, the study eye has the initial symptoms of an acute attack of primary angle closure; refer to the diagnostic criteria as attached in protocol;\n   2. The symptom duration of the acute attack ≥1 day, and the experienced highest intraocular pressure (IOP) in the study eye ≥30 mmHg;\n   3. After acute attack is controlled, the BCVA in the study eye is 20\u002F40 or higher;\n   4. After successful treatment of the acute attack, the IOP of the study eye \\\u003C21 mmHg before dosing.\n2. Patients with Acute Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)\n\n   1. Positive diagnosis of NAION with symptom onset within 14 days prior to planned dosing with FB1001, refer to the diagnostic criteria as attached in protocol;\n   2. Before drug administration, the BCVA score in the study eye by ETDRS is better than or equal to 15 letters.\n   3. The use of corticosteroids remains stable before and after drug administration (Dose adjust determined by investigator, if needed).\n3. At least 40 years old;\n4. Sufficiently clear ocular media and adequate pupil dilation to allow observation and assessment of the optic nerve and macula in the study eye;\n5. Female subjects of childbearing potential, and male subjects with partners of childbearing potential, should agree to use effective contraception from the time of signing the informed consent form until 3 months after the last drug administration.\n\nExclusion Criteria:\n\n1. Patients with Acute Primary Angle-Closure Glaucoma (APACG) Optic Neuropathy:\n\n   1. History or current diagnosis of glaucoma in both eyes;\n   2. History of chronic primary angle-closure glaucoma in any eye;\n   3. History of secondary angle-closure glaucoma in any eye.\n2. Patients with Acute Non-arteritic Anterior Ischemic Optic Neuropathy (NAION):Intraocular pressure \\>24 mmHg in the study eye;\n\n   1. History of optic neuritis or uveitis in any eye;\n   2. Clinical evidence of temporal arteritis;\n   3. History of collagen vascular disease or other inflammatory disease, or multiple sclerosis;\n   4. Currently diagnosed with NAION in both eyes.\n   5. The treatment with compound papaverine-like drugs is less than 5 half-lives from the administration of the study drug.\n3. The study eye has opacities of the refractive media or miosis that affect fundus examination, as judged by the investigator to be unsuitable for inclusion;\n4. The equivalent sphere of the refractive error in the study eye exceeds 6.0 diopters;\n5. The study eye has any ocular disease or past history that may affect vision and\u002For visual field other than acute angle-closure glaucoma and NAION \\[Vitreomacular traction syndrome, retinal detachment, Age-related macular degeneration, Retinal vein occlusion, Macular hole, Epiretinal membrane, Retinal pigment epithelial tear involving the macula, Diabetic retinopathy (except for mild non-proliferative diabetic retinopathy that does not require treatment), Optic neuritis, etc.\\], as judged by the investigator to be unsuitable for inclusion;\n6. The study eye has previously undergone subfoveal laser coagulation, vitrectomy, macular translocation surgery, or transpupillary thermotherapy;\n7. The study eye has undergone intraocular surgery (such as intraocular lens implantation, etc.) or periocular surgery within 90 days before drug administration, or eyelid surgery within 30 days before drug administration;\n8. The study eye has undergone YAG laser posterior capsulotomy within 28 days before drug administration;\n9. History of surgical procedure within 1 month before screening, and\u002For currently has unhealed wounds, ulcers, fractures, etc., and is judged by the investigator to be unsuitable for inclusion;\n10. The study eye has received intraocular or peribulbar injection of corticosteroids (such as triamcinolone, etc.) within 6 months before screening;\n11. Continuous use of systemic corticosteroids for more than 1 week within 90 days before drug administration (except for systemic steroid treatment for NAION before screening);\n12. Any eye has received any intravitreal anti-VEGF treatment (such as bevacizumab, aflibercept, etc.) within 90 days before drug administration;\n13. Any eye has a history of active ocular inflammation or infection within 30 days before drug administration;\n14. Presence of infectious diseases requiring systemic treatment (oral, intramuscular, or intravenous medication) before screening;\n15. Systemic application of nerve growth factor or BDNF-like treatment within 90 days before drug administration;\n16. Participation in any clinical trial for the treatment of optic neuropathy within 90 days before drug administration, with the exception of dietary supplements, vitamins, or minerals;\n17. Participation in any clinical trial within 60 days before drug administration;\n18. History of allergic reaction to fluorescein and indocyanine green, history of allergy to therapeutic or diagnostic biological products, or allergy to the study drug or its components.\n19. Currently using or likely to require systemic medication that may cause crystalline or retinal toxicity, such as deferoxamine, chloroquine\u002Fhydroxychloroquine, tamoxifen, phenothiazine, and ethambutol, etc.;\n20. History of myocardial infarction, unstable angina, coronary revascularization within 6 months before screening, cerebrovascular accident history (including TIA), other thromboembolic disease history (such as thromboangiitis, pulmonary embolism, deep vein thrombosis, portal vein thrombosis, etc.), New York Heart Association (NYHA) class ≥II heart failure, severe arrhythmia;\n21. Presence of systemic autoimmune diseases;\n22. Presence of disseminated intravascular coagulation and significant bleeding tendency (such as hemoptysis, hematemesis, severe purpura, etc.) within 3 months before screening, or having received anticoagulant or antiplatelet treatment other than aspirin\u002FNSAIDs within 14 days before screening; Blood PLT ≤ 100 × 10\\^9\u002FL, prothrombin time and activated partial thromboplastin time ≥ 3 seconds above the normal range (based on the normal values of the clinical trial institution's laboratory); taking antiplatelet drugs or anticoagulant drugs within 1 month before screening (patients taking a daily dose of aspirin ≤ 100mg are not included in this anticoagulant requirement, for patients taking aspirin, it is allowed to adjust the dose to 100mg and below on the day before screening to proceed with screening);\n23. Combined with severe liver and kidney diseases, or abnormal liver and kidney function during the screening period (ALT, AST ≥ 2.5 times the upper limit of the normal value; total bilirubin ≥ 1.5 times the upper limit of the normal value; creatinine, urea\u002Fblood urea nitrogen ≥ 1.2 times the upper limit of the normal value);\n24. Poorly controlled hypertension, defined as a single measurement of systolic blood pressure \\>180 mmHg, or two consecutive measurements of systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg (with a time interval of ≥30 minutes between measurements);\n25. Women who are already pregnant during the screening period, or are in the pregnancy or lactation period;\n26. Presence of active malignant tumors or a history of malignant tumors within 5 years before the baseline visit, except for completely cured in situ cervical cancer, and completely cured and regressed non-metastatic skin squamous cell carcinoma or basal cell carcinoma;\n27. History of mental illness, family history of mental illness, or emotional disorders as judged by the investigator or a psychiatrist;\n28. Other situations to be excluded judged by the investigator.","40 Years",{"count":206,"type":21},59,[208],"PHASE1","This study is designed for single-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single\u002Fmultiple intravitreal injection of FB1001 in patients with APACG(Acute Primary Angle-Closure Glaucoma) or NAION(Nonarteritic Anterior Ischemic Optic Neuropathy).",[31,211,212,213],"NAION - Non-Arteritic Ischemic Optic Neuropathy","APAC - Acute Primary Angle Closure","Glaucoma, Angle-Closure","2024-07-11",{"date":216,"type":81},"2024-07-17",{"date":218,"type":21},"2024-08-15",{"date":220,"type":21},"2026-10-31",{"name":222,"class":119},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":161,"sex":17,"minAge":18,"maxAge":231,"enrollmentInfo":232,"targetDuration":4,"studyType":22,"phases":234,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":143,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":4},"100496710","streetlab-assessment-tool-of-activities-daily-living-in-glaucoma-patient-100496710","NCT05747781","STReetlab Assessment Tool of Activities Daily Living in Glaucoma Patient","Validation of Standardized Tests Allowing the Evaluation of the Impacts of Glaucomatous Optic Neuropathy in Daily Life Activities","STRATAL-GL","Inclusion Criteria:\n\nGlaucoma patients:\n\n* Age: 18 - 80 years,\n* Visual acuity of at least 6\u002F10th binocular,\n* Patient followed at Quinze-Vingts and presenting with chronic stable glaucoma defined by the glaucoma ophthalmologist,\n* MMSE questionnaire score ≥ 25\u002F30 or ≥ 16\u002F25 (if the patient no longer drives),\n* Ability to give consent and comply with the study protocol,\n* Person with Social Security coverage.\n* Recruitment of glaucoma patients will be based on the criteria defined by the HPA classification (Appendix) on the basis of the Humphrey visual field, for categorization of patients into three stages of optic neuropathy progression (early stage \"1\", moderate \"2\" and advanced \"3\").\n\nFor the optional roadside fitness visit (V4), specific inclusion criteria will be required for this study: the roadside assessment will be performed with volunteers (GL and VS) who report being:\n\n* Always drivers in possession of a valid driver's license,\n* Driven at least 500 km in the past year.\n\nHealthy volunteer:\n\n* Age: 18 - 80 years.\n* Age and sex matching between healthy volunteers and glaucoma patients (± 5 years).\n* MMSE questionnaire score ≥ 25\u002F30.\n* Visual acuity of at least 10\u002F10th in binocular.\n* Ability to give consent and comply with the study protocol.\n* Person with a Social Security plan.\n\nFor the roadside fitness visit (V4), specific inclusion criteria will be required for this study: the roadside assessment will be performed with volunteers who declare themselves:\n\n* Always drivers in possession of a valid driver's license,\n* Driven at least 500 km in the past year.\n\nExclusion Criteria:\n\n* Pregnant women.\n* Inability to personally give consent.\n* Participants will not have neurodegenerative diseases or any other disease that could interfere with the assessments planned during this study.\n* Participants will not have any other ophthalmologic diseases other than glaucoma.\n* Drug treatments that may cause motor, visual, or cognitive impairment (PSAs, neuroleptics, etc.) or that may interfere with the study assessments.\n* Condition that limits ability to move.\n* Inability to read.","80 Years",{"count":233,"type":21},100,[24],"The impact of glaucomatous optic neuropathy on the daily life of patients is poorly characterized and does not benefit from standardized tests.\n\nThe development and validation of new tests could be used to assess the efficacy of innovative treatments for visually impaired patients and\u002For optimize management strategies.",[31],"2023-02-17",{"date":239,"type":81},"2023-02-28",{"date":241,"type":21},"2023-03-01",{"date":243,"type":21},"2027-03-31",{"name":245,"class":119},"Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts"]