[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"thyroid-associated-ophthalmopathies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:thyroid-associated-ophthalmopathies":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,56,82,109,133,152],{"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":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100640670","prospective-observational-study-of-smartphone-based-ai-self-monitoring-during-non-surgical-treatment-for-thyroid-eye-disease-thyroscope-100640670",false,"NCT07623993","Prospective Observational Study of Smartphone-Based AI Self-Monitoring During Non-Surgical Treatment for Thyroid Eye Disease (THYROSCOPE)","Prospective Observational Study of Smartphone-Based Self-Monitoring Using an Artificial Intelligence Solution During Non-Surgical Treatment for Thyroid Eye Disease","THYROSCOPE-TED","Inclusion Criteria:\n\n* Adults aged 19 years or older with a clinical diagnosis of thyroid eye disease (TED).\n* Patients with TED scheduled to initiate active non-surgical treatment, including but not limited to intravenous methylprednisolone, oral corticosteroids, radiotherapy, or biologic therapy.\n* Able to undergo baseline clinical assessment prior to initiation of the planned treatment course and expected routine follow-up evaluation during treatment, including an end-of-treatment assessment.\n* Able and willing to use their own smartphone to complete the study application-guided symptom questionnaire and capture standardized frontal facial images throughout the study period.\n* Willing to perform at least weekly home-based image capture and symptom reporting during the treatment course.\n* Able to participate in routine in-person follow-up visits and expected to provide at least two clinic-matched assessments, including baseline and at least one post-baseline assessment.\n* Voluntarily provides written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Severe eyelid deformities, facial deformities, or other facial\u002Fperiocular conditions that may interfere with standardized image acquisition or reliable AI-based image analysis.\n* Unable to use the study application or smartphone-based image capture procedure adequately for protocol-required self-monitoring.\n* Undergoing or planning to undergo surgical treatment for TED as the primary treatment modality during the study period.\n* History of ocular, eyelid, or orbital surgery within 3 months prior to enrollment.\n* Any medical, psychiatric, cognitive, or other condition that, in the investigator's judgment, may compromise protocol compliance, study participation, or data integrity.\n* Any other condition that the investigator judges to make the patient inappropriate for participation.","ALL","22 Years",{"count":20,"type":21},200,"ESTIMATED","OBSERVATIONAL","This prospective observational study evaluates the feasibility and clinical utility of a smartphone-based artificial intelligence (AI) self-monitoring system in adults with thyroid eye disease (TED) undergoing non-surgical treatment. Eligible participants will use their own smartphones and the study application (Glandy) to perform at least weekly home monitoring consisting of a symptom questionnaire (diplopia, pain on visual analog scale) and a standardized frontal facial photograph. AI-derived outputs (Glandy CAS, Glandy EXO, Glandy LID) obtained at routine clinic visits will be compared with standard clinician assessments (CAS total score, Hertel exophthalmometry, MRD1\u002FMRD2). AI outputs will not be used for real-time clinical decision-making during the study.",[25,26,27],"Thyroid Eye Disease (TED)","Graves Ophthalmopathy","Thyroid Associated Ophthalmopathies",[29,30,31,32,33,34,35,36,37,38,39,40,41,42],"Thyroid eye disease","TED","Graves orbitopathy","Artificial intelligence","Smartphone","Self-monitoring","Clinical Activity Score","CAS","Exophthalmometry","MRD1","MRD2","Remote monitoring","Digital health","Telemedicine","NOT_YET_RECRUITING","2026-05-28",{"date":46,"type":47},"2026-06-03","ACTUAL",{"date":49,"type":21},"2026-07-01",{"date":51,"type":21},"2027-12-31",{"name":53,"class":54},"THYROSCOPE INC.","INDUSTRY",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":55},"100592168","phase-3-mhb018a-treatment-in-patients-with-active-thyroid-eye-disease-100592168","NCT06989918","MHB018A Treatment in Patients With Active Thyroid Eye Disease","A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of MHB018A Injection in Subjects With Active Moderate-to-Severe Thyroid Eye Disease.","Inclusion Criteria:\n\n1. Subjects voluntarily participating in the study and signing the informed consent form;\n2. Aged 18-75 years (inclusive), of any gender;\n3. Clinical diagnosis of active Thyriod Eye Disease (TED). The Clinical Activity Score (CAS) of the study eye\u002Ftarget eye at screening and baseline must be ≥3 points (7-point scale).\n4. Subjects with a clinical diagnosis of moderate to severe TED at screening and baseline.\n5. Does not require immediate surgical ophthalmological intervention, and no corrective surgery\u002Forbital radiotherapy is planned during the study.\n6. Diabetic subjects must have well-controlled stable disease.\n7. Sufficient bone marrow and organ function.\n8. Eligible subjects of childbearing potential (male and female) must agree to use reliable contraceptive methods; female subjects of childbearing potential must have a negative blood pregnancy test within 7 days before the first use of the study drug and must not be breastfeeding.\n9. Subject is willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the study.\n\nExclusion Criteria:\n\n1. Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision within the last 6 months of two lines of Snellen chart, new visual field defect or color defect secondary to optic nerve involvement.\n2. Corneal decompensation unresponsive to medical management.\n3. Decrease in CAS of ≥ 2 points or decrease in proptosis of ≥ 2 mm between screening and baseline.\n4. Free thyroxine (FT4) and free triiodothyronine (FT3) levels \\\u003C50% above or below the normal reference range at screening.\n5. Subjects who have previously received orbital radiotherapy or ophthalmic surgery for TED.\n6. Subjects who received oral or intravenous corticosteroids or corticosteroid eye drops\u002Fointments for TED within 4 weeks before the first dose; subjects who received periorbital\u002Forbital steroid injections within 3 months before the first dose.\n7. Subjects who used oral or intravenous corticosteroids for reasons other than TED within 4 weeks prior to Screening, excluding local use (topical, nasal, inhalation).\n8. Any previous treatment with rituximab, tocilizumab, other immunosuppressive agent use within 3 months prior to Screening.\n9. Previous treatment targeting IGF-1R.\n10. Selenium and biotin must be discontinued 3 weeks prior to Screening and must not be restarted during the trial; however, taking a multivitamin that includes selenium and\u002For biotin is allowed.\n11. Use of an investigational agent for any condition within 30 days prior to Screening or anticipated use during the course of the trial.\n12. Identified pre-existing ophthalmic disease that, in the judgment of the Investigator, would preclude study participation or complicate interpretation of study results.\n13. Malignant condition in the past 5 years before signing the ICF (except successfully treated basal\u002Fsquamous cell carcinoma of the skin).\n14. Acute cardiovascular disease history or treatment within 6 months before the first dose.\n15. Presence of poorly controlled hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg; Renal artery stenosis.\n16. Pregnant or lactating women.\n17. Drug or alcohol abuse during the screening period.\n18. Hearing impairment history in either ear during the screening period; or abnormal pure tone audiometry results.\n19. Biopsy-proven or clinically suspected inflammatory bowel disease.\n20. Positive results for serum virology tests (defined as pos\n21. Subjects who received or planned to receive live or attenuated live vaccines within 4 weeks before the first dose or during the study period.\n22. Subjects who underwent major surgery within 4 weeks before the first dose or are expected to undergo surgery during the study period or within 4 weeks after the study.\n23. Known hypersensitivity to any of the components of MNB018A or prior hypersensitivity reactions to mAbs.","18 Years","75 Years",{"count":66,"type":21},108,"INTERVENTIONAL",[69],"PHASE3","The primary objective of this study is to investigate the efficacy, safety, and tolerability of MHB018A, a humanized anti-IGF1R antibody, administered q4W for 6 months, in comparison to placebo, in the treatment of participants suffering from active TED.",[27],"RECRUITING","2026-03-27",{"date":75,"type":47},"2026-04-02",{"date":77,"type":47},"2025-07-22",{"date":79,"type":21},"2027-07-31",{"name":81,"class":54},"Minghui Pharmaceutical (Hangzhou) Ltd",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":17,"minAge":63,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":55},"100622268","eye-tracking-study-on-eye-movement-function-and-visual-attention-patterns-in-patients-with-thyroid-associated-ophthalmopathy-100622268","NCT07381413","Eye Tracking Study on Eye Movement Function and Visual Attention Patterns in Patients With Thyroid-Associated Ophthalmopathy","TAO-A","Inclusion Criteria:\n\n* Aged between 18 and 70 years, inclusive.\n* Willing and able to provide written informed consent.\n* Best-corrected visual acuity (BCVA) ≥ 1.0 in both eyes, with no history of ocular diseases or thyroid disorders.\n\nExclusion Criteria:\n\n* Non-TAO Ocular Motility Disorders: History of conditions like myasthenia gravis, cranial nerve palsy, or congenital strabismus.\n* Neurological Diseases: Disorders affecting oculomotor control (e.g., Parkinson's, MS, stroke, or brain tumors).\n* Significant Visual Impairment: BCVA \\\u003C 0.5 due to media opacities or retinopathy, preventing clear visualization of stimuli.\n* Prior Ocular Surgery: History of surgeries affecting extraocular muscle mechanics (e.g., strabismus surgery, scleral buckling).\n* Psychiatric or Cognitive Disorders: Inability to follow instructions or conditions affecting eye movements (e.g., schizophrenia).\n* Medication Interference: Use of drugs affecting reaction time (e.g., sedatives) within 48 hours of testing.",true,"70 Years",{"count":92,"type":21},100,"This study focuses on eye health and visual function in patients with Thyroid-Associated Ophthalmopathy (TAO), a condition that often causes bulging eyes and restricted eye movement. The purpose of this study is to use non-invasive eye-tracking technology to evaluate how the disease affects eye movement function. The investigators hypothesize that compared to healthy individuals, patients with TAO will show measurable differences in eye stability and the ability to track moving objects. Additionally, the investigators believe the disease may alter how patients visually scan faces (e.g., avoiding eye contact). The study will enroll 100 participants, including both patients and healthy volunteers. By recording gaze patterns while participants look at a screen, the investigators aim to objectively quantify the physical and social impact of the disease, providing better data for future treatment plans.",[27,95],"Eye Tracking",[97,98],"TAO","eye tracking","2026-02-03",{"date":101,"type":47},"2026-02-06",{"date":103,"type":47},"2026-01-31",{"date":105,"type":21},"2029-05",{"name":107,"class":108},"Shanghai Changzheng Hospital","OTHER",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":63,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":67,"phases":118,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":55},"100604659","phase-4-evaluation-of-the-efficacy-and-safety-observation-of-ibi311-treatment-in-patients-with-inactive-tao-100604659","NCT07152392","Evaluation of the Efficacy and Safety Observation of IBI311 Treatment in Patients With Inactive TAO","Inclusion Criteria:\n\n* Diagnosed with TAO by Bartley criteria.\n* Moderate to severe patients defined by EUGOGO.\n* CAS \\\u003C3 (on the 7-item scale) for the study eye.\n* Participant with intractable diplopia, or incomplete closure of both eyes, or requiring further surgical intervention.\n* Participant with a strong willingness for further intervention.\n\nExclusion Criteria:\n\n* Anticipated need for intervention due to sight-threatening complications or other significant and acute deterioration in vision.\n* Combined with other lesions in the orbit.\n* Receive orbital radiotherapy or surgical treatment for TED, including orbital decompression, strabismus surgery and eyelid retraction correction.\n* During the screening period, if either ear has a history of tinnitus or other hearing impairment; Or abnormal pure tone audiometry results (defined as an average bone conduction hearing threshold of ≥25 dB at 0.5, 1, 2, 4 kHz or a bone conduction hearing threshold of ≥40 dB at any frequency).\n* At the time of screening, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 3 times ULN, or accompanied by active hepatitis B (defined as HBsAg positive with HBV-DNA load greater than 1000 IU\u002F mL), or being receiving anti-hepatitis B virus treatment.\n* During screening, the Glomerular Filtration Rate (GFR) was \\\u003C 30 ml\u002F min\u002F1.73m2 (using the MDRD formula: GFR =186× serum creatinine (mg\u002F dl) -1.154× (age) -0.203× (0.742 \\[if female\\]), unit conversion of serum creatinine: 1 μmol\u002FL=0.0113 mg\u002FdL); 10) At the time of screening, there was poorly controlled diabetes (defined as glycated hemoglobin ≥7.0% at the time of screening, or a new diabetes drug \\[oral or injection\\] or a dose change of the current prescribed diabetes drug \\> 10% within 60 days before screening).\n* Screening for poorly controlled hypertension, with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg; Or adjust the antihypertensive drug (dosage or type of drug) within 30 days before screening; Evidence of renal artery stenosis or unstable blood pressure (including orthostatic hypotension, etc.).\n* At the time of screening, the 12-lead ECG showed a heart rate of \\\u003C 50 beats\u002Fmin or \\> 100 beats\u002Fmin. The ECG indicated active heart disease, or the researchers believed that the abnormal ECG at the time of screening would interfere with the interpretation of the ECG results in the subsequent follow-up process. Especially, QTcF \\> 450 ms (for men) and QTcF \\> 470 ms (for women) should be excluded.\n* HIV antibody or HCV antibody positive individuals or those with active syphilis (defined as those with positive non-specific syphilis antibodies or those who need anti-syphilis treatment after consultation by the infectious disease department).\n* Any major illness\u002Fcondition or evidence of an unstable clinical condition that, in the investigators judgment, will substantially increase the risk to the participant, or confound the interpretation of safety assessments, if they were to participate in the study.\n* Any other condition that, in the opinion of the investigator, would impair the ability of the participant to comply with the study procedures or impair the ability to interpret data from the participants participation in the study.\n* Pregnant or lactating.","80 Years",{"count":117,"type":21},50,[119],"PHASE4","Thyroid-associated ophthalmopathy (TAO) is an organ-specific autoimmune disease closely related to thyroid disease, which leads the incidence of orbital disease in adults and is the most common cause of diffuse toxic goiter (Graves disease, GD). The clinical manifestations of TAO are complex and varied. In severe cases, it may seriously impair visual function, affect daily life, and even cause corneal ulceration, perforation, and blindness. Therefore, a reasonable and effective treatment plan should be chosen according to the degree of TAO.\n\nIBI311 is a fully human monoclonal insulin-like growth factor-1 receptor inhibitory antibody. It has binding activity against IGF-1R positive cells, can block the binding of IGF-1 and IGF-2 to IGF-1R, and has a dose-dependent effect. It can inhibit the proliferation of HT29 cells caused by the activation of the IGF-1R signaling pathway. Meanwhile, it can dose-dependently inhibit the proliferation of orbital fibroblasts and the secretion of hyaluronic acid (HA) in patients with TAO.\n\nHowever, there are still significant gaps in the existing research evidence: There is a lack of reports on the efficacy and safety of IBI311 in inactive moderate to severe TAO patients.\n\nThe aim of this clinical study is to:\n\n1. To evaluate the efficacy of IBI311 treatment in patients with inactive moderate to severe TAO.\n2. To observe the safety of IBI311 treatment in patients with inactive moderate to severe TAO.",[27],[123,30,124],"IGF-1R","MR Imaging","2025-08-31",{"date":127,"type":47},"2025-09-03",{"date":129,"type":47},"2025-04-15",{"date":131,"type":21},"2035-04-15",{"name":107,"class":108},{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":17,"minAge":63,"maxAge":115,"enrollmentInfo":140,"targetDuration":4,"studyType":67,"phases":142,"briefSummary":143,"conditions":144,"keywords":145,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":150,"leadSponsor":151,"locationsCount":55},"100604657","phase-4-efficacy-and-safety-of-sequential-hormone-therapy-and-tetuzumab-therapy-in-patients-with-moderate-to-severe-tao-in-the-active-stage-after-glucocorticoid-treatment-100604657","NCT07152366","Efficacy and Safety of Sequential Hormone Therapy and Tetuzumab Therapy in Patients With Moderate to Severe TAO in the Active Stage After Glucocorticoid Treatment.","Efficacy and Safety of Sequential Hormone Therapy and Tetuzumab Therapy in Patients With Moderate to Severe TAO in the Active Stage After Glucocorticoid Treatment","Inclusion Criteria:\n\n* Inclusion Criteria:\n* Diagnosed with TAO by Bartley criteria.\n* Moderate to severe patients defined by EUGOGO.\n* CAS ≥4 (on the 7-item scale) for the study eye.\n* participants have received glucocorticoid treatment for TAO in the past，but did not responsive or has an unsatisfactory effect.\n\nExclusion Criteria:\n\n* Anticipated need for intervention due to sight-threatening complications or other significant and acute deterioration in vision.\n* Combined with other lesions in the orbit.\n* Receive orbital radiotherapy or surgical treatment for TED, including orbital decompression, strabismus surgery and eyelid retraction correction.\n* During the screening period, if either ear has a history of tinnitus or other hearing impairment; Or abnormal pure tone audiometry results (defined as an average bone conduction hearing threshold of ≥25 dB at 0.5, 1, 2, 4 kHz or a bone conduction hearing threshold of ≥40 dB at any frequency).\n* At the time of screening, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 3 times ULN, or accompanied by active hepatitis B (defined as HBsAg positive with HBV-DNA load greater than 1000 IU\u002FmL), or being receiving anti-hepatitis B virus treatment.\n* During screening, the Glomerular Filtration Rate (GFR) was \\\u003C 30 ml\u002Fmin\u002F1.73m2 (using the MDRD formula: GFR =186× serum creatinine (mg\u002Fdl) -1.154× (age) -0.203× (0.742 \\[if female\\]), unit conversion of serum creatinine: 1 μmol\u002FL=0.0113 mg\u002FdL); 10) At the time of screening, there was poorly controlled diabetes (defined as glycated hemoglobin ≥7.0% at the time of screening, or a new diabetes drug \\[oral or injection\\] or a dose change of the current prescribed diabetes drug \\> 10% within 60 days before screening).\n* Screening for poorly controlled hypertension, with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg; Or adjust the antihypertensive drug (dosage or type of drug) within 30 days befor screening; Evidence of renal artery stenosis or unstable blood pressure (including orthostatic hypotension, etc.).\n* At the time of screening, the 12-lead ECG showed a heart rate of \\\u003C 50 beats\u002Fmin or \\> 100 beats\u002Fmin. The ECG indicated active heart disease, or the researchers believed that the abnormal ECG at the time of screening would interfere with the interpretation of the ECG results in the subsequent follow-up process. Especially, QTcF \\> 450 ms (for men) and QTcF \\> 470 ms (for women) should be excluded.\n* HIV antibody or HCV antibody positive individuals or those with active syphilis (defined as those with positive non-specific syphilis antibodies or those who need anti-syphilis treatment after consultation by the infectious disease department).\n* Any major illness\u002Fcondition or evidence of an unstable clinical condition that, in the investigators judgment, will substantially increase the risk to the participant, or confound the interpretation of safety assessments, if they were to participate in the study.\n* Any other condition that, in the opinion of the investigator, would impair the ability of the participant to comply with the study procedures or impair the ability to interpret data from the participants participation in the study.\n* Pregnant or lactating.",{"count":141,"type":21},96,[119],"Thyroid-associated ophthalmopathy (TAO) is an organ-specific autoimmune disease closely related to thyroid disease, which leads the incidence of orbital disease in adults and is the most common cause of diffuse toxic goiter (Graves disease, GD). The clinical manifestations of TAO are complex and varied. In severe cases, it may seriously impair visual function, affect daily life, and even cause corneal ulceration, perforation, and blindness. Therefore, a reasonable and effective treatment plan should be chosen according to the degree of TAO. Tetuzumab (IBI311) is a fully human monoclonal insulin-like growth factor-1 receptor inhibitory antibody. It has binding activity against IGF-1R positive cells, can block the binding of IGF-1 and IGF-2 to IGF-1R, and has a dose-dependent effect. It can inhibit the proliferation of HT29 cells caused by the activation of the IGF-1R signaling pathway. Meanwhile, it can dose-dependently inhibit the proliferation of orbital fibroblasts and the secretion of hyaluronic acid (HA) in patients with TAO.\n\nHowever, there are still significant gaps in the existing research evidence: There is a lack of reports on the efficacy and safety of Tetuzumab (IBI311) in the population after glucocorticoid treatment.\n\nThe aim of this clinical study is to:\n\n1. To evaluate the efficacy of IBI311 treatment in patients with active moderate to severe TAO after glucocorticoid treatment.\n2. To observe the safety of IBI311 treatment in patients with active moderate to severe TAO after glucocorticoid treatment.",[27],[123,30,146,147],"glucocorticoids","MRI",{"date":127,"type":47},{"date":129,"type":47},{"date":131,"type":21},{"name":107,"class":108},{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":17,"minAge":63,"maxAge":115,"enrollmentInfo":158,"targetDuration":4,"studyType":67,"phases":160,"briefSummary":161,"conditions":162,"keywords":163,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},"100604655","phase-4-the-safety-and-efficacy-of-sequential-hormone-therapy-and-ibi311-therapy-in-patients-with-active-moderate-to-severe-tao-in-the-initial-treatment-100604655","NCT07152340","The Safety and Efficacy of Sequential Hormone Therapy and IBI311 Therapy in Patients With Active Moderate to Severe TAO in the Initial Treatment.","Inclusion Criteria:\n\n* Diagnosed with TAO by Bartley criteria.\n* Moderate to severe patients defined by EUGOGO.\n* CAS ≥4 (on the 7-item scale) for the study eye.\n* Have not received glucocorticoid treatment for TAO in the past.\n\nExclusion Criteria:\n\n* Anticipated need for intervention due to sight-threatening complications or other significant and acute deterioration in vision.\n* Combined with other lesions in the orbit.\n* Receive orbital radiotherapy or surgical treatment for TED, including orbital decompression, strabismus surgery and eyelid retraction correction.\n* During the screening period, if either ear has a history of tinnitus or other hearing impairment; Or abnormal pure tone audiometry results (defined as an average bone conduction hearing threshold of ≥25 dB at 0.5, 1, 2, 4 kHz or a bone conduction hearing threshold of ≥40 dB at any frequency).\n* At the time of screening, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 3 times ULN, or accompanied by active hepatitis B (defined as HBsAg positive with HBV-DNA load greater than 1000 IU\u002FmL), or being receiving anti-hepatitis B virus treatment.\n* During screening, the Glomerular Filtration Rate (GFR) was \\\u003C 30 ml\u002Fmin\u002F1.73m2 (using the MDRD formula: GFR =186× serum creatinine (mg\u002Fdl) -1.154× (age) -0.203× (0.742 \\[if female\\]), unit conversion of serum creatinine: 1 μmol\u002FL=0.0113 mg\u002FdL); 10) At the time of screening, there was poorly controlled diabetes (defined as glycated hemoglobin ≥7.0% at the time of screening, or a new diabetes drug \\[oral or injection\\] or a dose change of the current prescribed diabetes drug \\> 10% within 60 days before screening).\n* Screening for poorly controlled hypertension, with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg; Or adjust the antihypertensive drug (dosage or type of drug) within 30 days before screening; Evidence of renal artery stenosis or unstable blood pressure (including orthostatic hypotension, etc.).\n* At the time of screening, the 12-lead ECG showed a heart rate of \\\u003C 50 beats\u002Fmin or \\> 100 beats\u002Fmin. The ECG indicated active heart disease, or the researchers believed that the abnormal ECG at the time of screening would interfere with the interpretation of the ECG results in the subsequent follow-up process. Especially, QTcF \\> 450 ms (for men) and QTcF \\> 470 ms (for women) should be excluded.\n* HIV antibody or HCV antibody positive individuals or those with active syphilis (defined as those with positive non-specific syphilis antibodies or those who need anti-syphilis treatment after consultation by the infectious disease department).\n* History of systemic (eg, oral or IV) steroid use of methylprednisolone for the treatment of TAO.\n* Any major illness\u002Fcondition or evidence of an unstable clinical condition that, in the investigators judgment, will substantially increase the risk to the participant, or confound the interpretation of safety assessments, if they were to participate in the study.\n* Any other condition that, in the opinion of the investigator, would impair the ability of the participant to comply with the study procedures or impair the ability to interpret data from the participants participation in the study.\n* Pregnant or lactating.",{"count":159,"type":21},64,[119],"Thyroid-associated ophthalmopathy (TAO) is an organ-specific autoimmune disease closely related to thyroid disease, which leads the incidence of orbital disease in adults and is the most common cause of diffuse toxic goiter (Graves disease, GD). The clinical manifestations of TAO are complex and varied. In severe cases, it may seriously impair visual function, affect daily life, and even cause corneal ulceration, perforation, and blindness. Therefore, a reasonable and effective treatment plan should be chosen according to the degree of TAO.\n\nTetuzumab (IBI311) is a fully human monoclonal insulin-like growth factor-1 receptor inhibitory antibody. It has binding activity against IGF-1R positive cells, can block the binding of IGF-1 and IGF-2 to IGF-1R, and has a dose-dependent effect. It can inhibit the proliferation of HT29 cells caused by the activation of the IGF-1R signaling pathway. Meanwhile, it can dose-dependently inhibit the proliferation of orbital fibroblasts and the secretion of hyaluronic acid (HA) in patients with TAO.\n\nHowever, there are still significant gaps in the existing research evidence: the lack of head-to-head studies of temumab and glucocorticoids.\n\nThe aim of this clinical study is to:\n\n1. To evaluate the efficacy of IBI311 treatment in patients with active moderate to severe TAO in the initial treatment.\n2. To observe the safety of IBI311 treatment in patients with active moderate to severe TAO in the initial treatment.\n3. Head-to-head comparison of sequential hormone therapy and IBI311 therapy in patients with active moderate to severe TAO in the initial treatment.",[27],[123,30,146,164],"MRI imaging",{"date":127,"type":47},{"date":167,"type":47},"2025-04-10",{"date":169,"type":21},"2030-05-01",{"name":107,"class":108},2]