[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638142":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":57,"centralContacts":58,"locations":57,"responsibleParty":64,"collaborators":57,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":57,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":57,"enrollmentInfo":75,"targetDuration":57,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":88,"whyStopped":57,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":57},{"fullName":5,"class":6},"Zhongmou Therapeutics","INDUSTRY",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Low Dose","EXPERIMENTAL","IVT administration of a single low dose AGX-08 injection",[13],"Drug: AGX-08-L",{"label":15,"type":10,"description":16,"interventionNames":17},"Middle Dose","IVT administration of a single middle dose AGX-08 injection",[18],"Drug: AGX-08-M",{"label":20,"type":10,"description":21,"interventionNames":22},"High Dose","IVT administration of a single high dose AGX-08 injection",[23],"Drug: AGX-08-H",{"label":25,"type":26,"description":27,"interventionNames":28},"Control","SHAM_COMPARATOR","Sham IVT injection",[29],"Procedure: AGX-08-S",[31,38,44,50],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","AGX-08-L","rAAV2.AG-eNCRV intravitreal injection of low dose",[9],[37],"Low dose",{"type":32,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"AGX-08-M","rAAV2.AG-eNCRV intravitreal injection of middle dose",[15],[43],"Middle dose",{"type":32,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"AGX-08-H","rAAV2.AG-eNCRV intravitreal injection of high dose",[20],[49],"High dose",{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"PROCEDURE","AGX-08-S","sham intravitreal injection of AGX-08 (not actual injection)",[25],[56],"Sham control",null,[59],{"name":60,"role":61,"phone":62,"phoneExt":57,"email":63},"Windy Zhou","CONTACT","+86 18986214263","zmt@zmtherapeutics.com",{"type":65,"investigatorFullName":57,"investigatorTitle":57,"investigatorAffiliation":57,"oldNameTitle":57,"oldOrganization":57},"SPONSOR","100638142","early-phase-1-safety-and-efficacy-study-of-novel-gene-therapy-agx-08-for-geographic-atrophy-100638142",false,"NCT07602127","Safety and Efficacy Study of Novel Gene Therapy AGX-08 for Geographic Atrophy","Prospective, Dose-Escalating, Investigator Initiated Trial to Evaluate the Safety and Efficacy of AGX-08 in Geographic Atrophy","Inclusion Criteria:\n\n1. Clinically confirmed diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD);\n2. Age ≥ 50 years, regardless of sex;\n3. Best-corrected visual acuity (BCVA) in the study eye measured using the ETDRS chart at a starting distance of 4 meters must be ≤77 letters (Snellen equivalent ≤20\u002F63), with vision no worse than light perception; the fellow eye must not have better visual acuity than the study eye;\n4. GA lesion size between 2.5 and 17.5 mm² with clearly defined borders. For multifocal GA, at least one lesion must be ≥1.25 mm² (0.5 disc area) to ensure measurable efficacy assessment;\n5. Presence of choroidal neovascularization (CNV) in the fellow eye is allowed;\n6. Women of childbearing potential must have a negative pregnancy test (blood or urine);\n7. Women of childbearing potential and male participants must agree to use effective contraception during the study and for 3 months after completion, with no plans for reproduction;\n8. Willing and able to provide written informed consent and comply fully with the study protocol.\n\nExclusion Criteria:\n\n1. GA caused by conditions other than AMD (e.g., Stargardt disease, cone-rod dystrophy, or other inherited macular dystrophies);\n2. Aphakia in the study eye, or cataract surgery\u002FYAG capsulotomy within 3 months prior to screening;\n3. Refractive status or axial length outside the following range: spherical equivalent between -6.00D and +5.00D, and axial length between 21 mm and 26 mm;\n4. Two baseline BCVA measurements (ETDRS) taken at least 14 days apart during screening differ by \\>30%;\n5. Current or prior evidence of exudative (wet) AMD in the study eye, including retinal pigment epithelium tear, retinal vascular occlusions, history of corneal transplantation, or any neovascularization confirmed by fluorescein angiography;\n6. Active ocular diseases in the study eye, including inflammation, other macular diseases, glaucoma, ocular hypertension, or acute\u002Fchronic ocular infections;\n7. Major ocular surgery within 3 months prior to screening;\n8. History of retinal detachment or other fundus diseases unsuitable for study participation;\n9. Prior macular laser photocoagulation with irreversible retinal damage;\n10. Pregnant or lactating women, or participants unwilling to use effective contraception for 12 months before and after study intervention;\n11. Narrow anterior chamber angle or other contraindications to pupil dilation;\n12. Any ocular condition that may interfere with visual acuity assessment, OCT, or other ophthalmic evaluations;\n13. History of hypersensitivity to contrast agents, study drugs, or excipients;\n14. Allergy to corticosteroids, intolerance to protocol-required corticosteroid therapy, or contraindicated active infections;\n15. Severe systemic diseases, psychiatric disorders, uncontrolled chronic conditions, or other medical conditions that may increase study risk (e.g., malignancy, metabolic or autoimmune diseases);\n16. History of malignancy within 5 years (except cured basal cell carcinoma of the skin or cervical carcinoma in situ);\n17. Receiving or likely to receive immunosuppressive therapy outside this study;\n18. Participation in another investigational drug study within 3 months prior to screening;\n19. Prior gene therapy other than this study;\n20. Any condition that may compromise scientific evaluation of the study;\n21. Any contraindication to intravitreal (IVT) injection;\n22. Any other condition deemed unsuitable by the investigator.","ALL","50 Years",{"count":76,"type":77},24,"ESTIMATED","INTERVENTIONAL",[80],"EARLY_PHASE1","This is AGX-08's safety, tolerability, and efficacy in Geographic Atrophy first-in-human study. This trial is meant to evaluate the safety and efficacy of AGX-08 in Geographic Atrophy patients. Unilateral intravitreal injections (IVT) will be given into the subject's Study Eye.",[83],"Geographic Atrophy",[85,86,87],"GA","AMD","dry AMD","NOT_YET_RECRUITING","2026-05-20",{"date":91,"type":92},"2026-05-22","ACTUAL",{"date":94,"type":77},"2026-07-01",{"date":96,"type":77},"2029-12-30",{"name":5,"class":6}]