[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Guangzhou Jiayin Biotech Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":112},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,65,89],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100606645","phase-1-evaluating-the-safety-and-preliminary-efficacy-of-exg202-gene-therapy-for-neovascular-amd-100606645",false,"NCT07178249","Evaluating the Safety and Preliminary Efficacy of EXG202 Gene Therapy for Neovascular AMD","A Phase I\u002FII Clinical Study Evaluating the Safety and Preliminary Efficacy of EXG202 in Patients With Neovascular Age-related Macular Degeneration (nAMD)","Inclusion Criteria:\n\n1. Male or female, aged ≥50 years old;\n2. The study eye must be diagnosed of wAMD and current active lesions;\n3. Subjects have clear refractive media and sufficient pupil dilation at the time of screening to obtain high-quality retinal images for confirmation of diagnosis;\n4. Subjects (including male subjects) have no pregnancy plans during the screening period and the entire trial period and voluntarily take effective contraceptive measures and have no sperm or egg donation plans;\n5. Subjects are Voluntarily participate in this clinical trial, understand the research procedures and sign the informed consent form before screening; subjects have good compliance and are willing to abide by the research procedures.\n\nExclusion Criteria:\n\n1. The study eye has any eye disease other than wAMD that may affect central vision and\u002For macular detection ;\n2. The study eye has a history of retinal detachment or retinal detachment during the screening period;\n3. The study eye has MNV caused by reasons other than wAMD (such as diabetic retinopathy, pathological myopia, retinal vein occlusion, angioid streak disease, ocular histoplasmosis, trauma, etc.), and a history of macular pathology unrelated to wAMD;\n4. Any intraocular surgery is planned for the study eye during the study period;\n5. The study eye currently has retinal angiomatous proliferation (RAP), central serous chorioretinopathy or symptomatic vitreomacular traction syndrome;\n6. Presence of glaucoma or optic neuropathy that involves or compromises the central visual field of the study eye or presence of uncontrolled high intraocular pressure in the study eye；\n7. The fellow eye meets the definition of legal blindness；\n8. Hormone-induced increased intraocular pressure in any eye；\n9. Active infection in any eye this trial (such as those who cannot understand and comply with the trial requirements or are deemed unsuitable for safety reasons).","ALL","50 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","VEGF inhibitors (anti-VEGF),such as aflibercept has been shown to be safe and effective for treating nAMD and have demonstrated improvement in vision. However, anti-VEGF therapy is administered frequently via intravitreal injection and can be a significant burden to the patients.\n\nEXG 202 is a recombinant adeno-associated virus (rAAV) gene therapy vector carrying a coding sequence for a soluble anti-VEGF protein. The long-term, stable delivery of this therapeutic protein following a 1 time gene therapy treatment for nAMD could potentially reduce the treatment burden of currently available therapies while maintaining vision with a favorable benefit.",[27],"Wet Age-related Macular Degeneration","NOT_YET_RECRUITING","2025-09-10",{"date":31,"type":32},"2025-09-17","ACTUAL",{"date":34,"type":20},"2025-10-16",{"date":36,"type":20},"2032-12-30",{"name":38,"class":39},"Guangzhou Jiayin Biotech Ltd","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":4,"briefSummary":50,"conditions":51,"keywords":52,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100582146","a-long-term-follow-up-study-of-exg102-031-in-participants-with-wamd-100582146","NCT06859515","A Long-term Follow up Study of EXG102-031 in Participants With wAMD","A Long-term Follow-up Study to Evaluate the Injection of EXG102-031 Ophthalmic Injection in Participants With Wet Age-related Macular Degeneration (wAMD).","Inclusion Criteria:\n\n1. Previously received treatment with EXG102-031 in the study (EXG102-031-111);\n2. Paticipantes are informed consent and willingness to follow protocol procedures.\n\nExclusion Criteria:\n\n1\\. Paticipantes are unwilling or unable to participate in long-term follow-up",{"count":48,"type":20},42,"OBSERVATIONAL","This is a long-term, safety and efficacy follow-up study of patients in the EXG102-031-111 gene therapy clinical trial for wAMD. Patients will complete visits from the parent study, and then into this long-term follow-up study for continuous safety monitoring for up to 5 years.",[27],[53,54],"AAV","wAMD","RECRUITING","2025-08-14",{"date":58,"type":32},"2025-08-15",{"date":60,"type":32},"2025-03-13",{"date":62,"type":20},"2030-12-01",{"name":38,"class":39},1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100584373","early-phase-1-to-evaluate-the-safety-and-preliminary-efficacy-of-intravitreal-exg202-injection-in-patients-with-wet-neovascular-age-related-macular-degeneration-wamd-100584373","NCT06888492","To Evaluate the Safety and Preliminary Efficacy of Intravitreal EXG202 Injection in Patients with Wet (neovascular) Age-related Macular Degeneration (wAMD)","An Open-label, Dose-escalation Study to Evaluate the Safety and Efficacy of Intravitreal EXG202 Injection in Patients with Wet (neovascular) Age-related Macular Degeneration (wAMD)","Inclusion Criteria:\n\n1. Male or female, aged ≥50 years old;\n2. The study eye must meet the following criteria:\n\n   A. Diagnosed of wAMD and current active lesions; active, defined as the presence of any of the following lesions in the macular area upon OCT examination: a) intraretinal hemorrhage or fluid; b) subretinal fluid; c) subretinal hemorrhage; B. The BCVA score tested during screening using the ETDRS eye chart (see Appendix 3 for details) must be between 73-19 letters (including boundary values), (equivalent to Snellen visual acuity of 20\u002F40 to 20\u002F400);\n3. Clinically meaningful response to standard anti-VEGF therapy within 6 months before screening or during the lead-in period of screening.\n4. The subject has clear refractive media and sufficient pupil dilation at the time of screening to obtain high-quality retinal images for confirmation of diagnosis;\n5. Subjects (including male subjects) have no pregnancy plans during the screening period and the entire trial period and voluntarily take effective contraceptive measures and have no sperm or egg donation plans;\n6. Voluntarily participate in this clinical trial, understand the research procedures and sign the informed consent form before screening; have good compliance and are willing to abide by the research procedures.\n\nExclusion Criteria:\n\n1. The study eye has any eye disease other than wAMD that may affect central vision and\u002For macular detection (such as macular hole, macular epiretinal membrane, etc.);\n2. The study eye has a history of retinal detachment or retinal detachment during the screening period (such as rhegmatogenous retinal detachment, tractional retinal detachment, etc.);\n3. The study eye has MNV caused by reasons other than wAMD (such as diabetic retinopathy, pathological myopia, retinal vein occlusion, angioid streak disease, ocular histoplasmosis, trauma, etc.), and a history of macular pathology unrelated to wAMD;\n4. The study eye plans to undergo any intraocular surgery during the study period;",{"count":73,"type":20},8,[75],"EARLY_PHASE1","The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of intravitreal injection of EXG202 in subjects with neovascular age-related Macular Degeneration (nAMD).",[78,27],"Wet Age-related Macular Degeneration (wAMD)",[54,53],"2025-03-20",{"date":82,"type":32},"2025-03-21",{"date":84,"type":20},"2025-03-28",{"date":86,"type":20},"2026-04-30",{"name":38,"class":39},2,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":96,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":99,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100579070","phase-1-the-safety-and-efficacy-of-intravenous-exg110-in-patients-with-fabry-disease-100579070","NCT06819514","The Safety and Efficacy of Intravenous EXG110 in Patients With Fabry Disease","A Phase 1\u002F2, Multicenter, Open-label,Dose-escalation Study to Evaluate the Safety and Efficacy of Intravenous EXG110 in Patients With Fabry Disease","Inclusion Criteria:\n\n1. Age ≥18 years old, male or female\n2. Clinical symptoms (at least one Fabry disease related symptom) and genetic diagnosis of Fabry disease\n3. Prior or no prior ERT treatment\n4. Have renal or cardiac involvement\n5. The participant voluntarily participate and are fully informed, fully understood the study, can comply with the requirements of the protocol, and voluntarily provide biological samples for testing according to the requirements of the protocol\n\nExclusion Criteria:\n\n1. Screening period laboratory test results: a) aspartate aminotransferase or alanine aminotransferase \\> 1.5× upper limit of normal (ULN);b) Total bilirubin \\> 1.5× upper limit of normal (ULN);c) Alkaline phosphatase \\> 2× upper limit of normal (ULN);d) Hypoalbuminemia ≥ grade 2\n2. Serum virology test: a) Hepatitis B: Hepatitis B virus surface antigen (HBsAg) positive, and hepatitis B virus-deoxyribonucleic acid (HBV-DNA) higher than the upper limit of normal detection;b) Hepatitis C: if the hepatitis C virus (HCV) antibody is positive, and the hepatitis C virus-ribonucleic acid (HCV-RNA) is higher than the upper limit of normal test value;c) Syphilis: positive for syphilis screening (Tp-Ab) and positive for syphile-specific antibodies;d) HIV: Known human immunodeficiency virus (HIV) positive history or HIV screening positive\n3. Current or have a history of serious cardiovascular disease and surgical history\n4. Current underlying liver disease or history of liver disease, as assessed by the investigator, that may affect the safety assessment of the product\n5. Acute\u002Fchronic infection or other chronic disease that the investigator evaluated will increase the risk of participants in the study\n6. Those who have a history of epilepsy, mental illness (such as schizophrenia, depression, mania or anxiety, etc.) or obvious mental disorders, and are incapacitated or cognitively incapacitated due to other reasons.\n7. Participant with a history of malignant tumor or currently suffering from any malignant tumor (except for the following tumor diseases: skin basal cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ , skin squamous cell carcinoma has been controlled after treatment);\n8. Participant with active autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, immune vasculitis, inflammatory bowel disease, etc.);\n9. known history of allergy to the components of the investigational products\n10. Participant with a history of drug use or drug abuse or alcoholism\n11. Has received, or currently receiving, a clinical trial of another investigational drug\u002Fmedical device or treatment (other than vitamins and minerals) within 3 months prior to signing the informed consent form (or within 5 half-lives of the investigational drug, whichever is longer)\n12. Previous treatment with gene therapy products\n13. Those who had received live attenuated vaccine\u002Fvaccine within 12 weeks prior to screening or planned to receive it during the study\n14. Other clinical conditions that the investigators evaluated needed to be excluded","18 Years",{"count":98,"type":20},16,[23,24],"A phase 1\u002F2, multicenter, open-label, Dose-escalation study to evaluate the safety and efficacy of intravenous EXG110 in patients with Fabry disease",[102],"Fabry Disease","2025-02-10",{"date":105,"type":32},"2025-02-11",{"date":107,"type":20},"2025-03-01",{"date":109,"type":20},"2028-03-15",{"name":38,"class":39},3,""]