[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zhongmou Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":140},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,74,101],{"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":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"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":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"Geographic Atrophy",[28,29,30],"GA","AMD","dry AMD","NOT_YET_RECRUITING","2026-05-20",{"date":34,"type":35},"2026-05-22","ACTUAL",{"date":37,"type":20},"2026-07-01",{"date":39,"type":20},"2029-12-30",{"name":41,"class":42},"Zhongmou Therapeutics","INDUSTRY",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":4},"100614658","phase-1-prospective-randomized-sham-controlled-dose-finding-iii-trial-of-safety-and-efficacy-of-modified-optogenetic-gene-therapy-zm-02-injection-100614658","NCT07282457","Prospective, Randomized, Sham-controlled, Dose-finding I\u002FII Trial of Safety and Efficacy of Modified Optogenetic Gene Therapy (ZM-02 Injection)","A Prospective, Randomized, Sham-controlled, Dose-finding Phase 1\u002F2 Two-part Trial to Evaluate the Safety, Tolerability, and Efficacy of ZM-02 Injection in Patients With Advanced Retinitis Pigmentosa","PRISM","Inclusion Criteria\n\n1. Male or female participants aged 6 to 60 years.\n2. Clinical diagnosis of advanced retinitis pigmentosa (RP).\n3. Best corrected visual acuity at or below the protocol-defined threshold in the study eye.\n4. Presence of sufficient retinal structure in the study eye as determined by screening assessments.\n5. Ability to understand and sign informed consent (and assent, when applicable).\n\nExclusion Criteria\n\n1. Presence of other ocular conditions that could interfere with study assessments.\n2. History of significant ocular surgery in the study eye within a protocol-defined period.\n3. Active ocular infection or inflammation.\n4. Clinically significant systemic disease that could increase study risk or interfere with assessments.\n5. Positive screening for clinically significant infectious diseases, as defined in the protocol.\n6. Pregnant or breastfeeding individuals.\n7. Any condition that, in the investigator's judgment, would make the participant unsuitable for study participation.","6 Years","60 Years",{"count":54,"type":20},21,[56,57],"PHASE1","PHASE2","This is a Phase 1\u002F2, multi-center, randomized, sham-controlled, dose-escalation study evaluating ZM-02 in patients with advanced retinitis pigmentosa (RP).",[60],"Retinitis Pigmentosa (RP)",[62,63,64,65],"gene therapy","AAV","RP","optogenetics","2026-04-09",{"date":68,"type":35},"2026-04-13",{"date":70,"type":20},"2026-06-25",{"date":72,"type":20},"2031-12-25",{"name":41,"class":42},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100538577","early-phase-1-safety-and-efficacy-study-of-novel-gene-therapy-zm-02-for-retinitis-pigmentosa-patients-100538577","NCT06292650","Safety and Efficacy Study of Novel Gene Therapy ZM-02 for Retinitis Pigmentosa Patients","Prospective, Dose-Escalating, Investigator Initiated Trial to Evaluate the Safety and Efficacy of ZM-02 in Retinitis Pigmentosa","MOON","Inclusion Criteria:\n\nPatients who meet all of the following criteria can be selected as subjects:\n\n1. Clinically diagnosed with retinal pigment degeneration\n2. The visual acuity of study eye is no better than the finger counting, while the visual acuity of the study eye is not better than that of the contralateral eye\n3. The subject has had visual experience above the finger counting\n4. In the OCT examination of the tested eye, the disappearance of the ellipsoid zone is observed, but the inner nuclear layer and the nerve fiber layer of the retina are still present\n5. The refractive power of the tested eye is between -6.00 D and +6.00 D\n6. Not infected with the Human Immunodeficiency Virus (HIV) and other acute and chronic infectious diseases\n7. Voluntarily sign an Informed Consent Form (ICF), and the age is not less than 18 years and not more than 65 years\n8. Able to fully understand and agree to cooperate with the implementation of the research protocol\n\nExclusion Criteria:\n\nSubjects who meet any one of the following exclusion criteria will be excluded from the study:\n\n1. Pregnant women, breastfeeding women, or male and female subjects who do not agree to contraception during the 12 months before and after medication\n2. Subjects with narrow anterior chamber angles or any other medical conditions that contraindicate pupil dilation\n3. Subjects allergic to corticosteroids, who are unable to tolerate the corticosteroid treatment described in the protocol, or have active 4. concurrent infections that contraindicate treatment\n4. Subjects with systemic diseases, or other medical or mental illnesses, or other safety concerns for the study\n5. Subjects with other symptoms and\u002For diseases or conditions that can alter visual function, including but not limited to glaucoma and central nervous system lesions (mild cataracts are not included in this restriction)\n6. Eye diseases that may interfere with the assessment of vision during the study and\u002For interfere with other ocular assessments such as OCT\n7. Diseases that may affect the clinical trial, such as tumors, metabolic, immune-related diseases, etc.\n8. Subjects who have undergone major eye surgery within the last 3 months before screening\n9. Subjects with a history of malignant tumors within the last 5 years\n10. Subjects with other retinal diseases not suitable for this study, such as retinal detachment\n11. Patients undergoing or potentially undergoing immunosuppressive treatment for other diseases, excluding this study\n12. Participation in any clinical trials other than this study within the last 3 months\n13. Subjects who have received gene therapy outside of this study\n14. Other reasons deemed by the researcher as unsuitable for participation in this study","18 Years","65 Years",{"count":85,"type":20},12,[23],"This is zM-02's safety, tOlerability, and efficacy in retinitis pigmentOsa first-in-humaN study (MOON). This trial is meant to evaluate the safety and efficacy of ZM-02 in Retinitis pigmentosa (RP) patients. Unilateral intravitreal injections (IVT) will be given into the subject's Study Eye.",[89],"Retinitis Pigmentosa",[62,63,64,65],"RECRUITING","2026-03-25",{"date":94,"type":35},"2026-03-31",{"date":96,"type":35},"2024-02-25",{"date":98,"type":20},"2028-12-25",{"name":41,"class":42},1,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":109,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":112,"phases":4,"briefSummary":113,"conditions":114,"keywords":125,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":100},"100599518","natural-history-study-of-inherited-retinal-diseases-100599518","NCT07085533","Natural History Study of Inherited Retinal Diseases","Color Vision Loss Progression in IRD Patients: Retinal Structural Changes Correlations, and a Novel Color Discrimination Test for Extreme Low Vision Patients","MojiLVCDT","Inclusion Criteria:\n\n1. Color Perception and Communication Ability Participants must have the ability to verbally identify or describe colors and test stimuli. This requires adequate cognitive and communicative capacity to understand instructions and respond appropriately during color vision testing.\n2. Diagnosis of Inherited Retinal Dystrophy (IRD Group Only) Participants assigned to the IRD group must have a confirmed clinical diagnosis of an inherited retinal dystrophy\n3. No Evidence of Inherited Retinal Disease (Control Group Only)\n\nParticipants in the control group must have:\n\n* No known history or clinical evidence of inherited retinal degeneration\n* Normal retinal health or only non-retinal ocular conditions not affecting retinal function (e.g., mild cataract, corrected refractive error)\n* Normal or expected-normal color vision\n\nExclusion Criteria:\n\n1. Non retinal causes of color vision loss\n\n   * Optic neuropathies (e.g., optic neuritis, glaucoma related optic nerve damage)\n   * Cortical vision impairments affecting color perception\n   * Any other neurological or optic nerve pathology causing color vision deficiency\n2. Psychological or cognitive conditions affecting color perception or communication\n\n   * Severe developmental delays\n   * Cognitive impairments interfering with ability to comprehend or reliably perform color vision tests\n   * Psychiatric conditions that impair visual interpretation or reliable testing\n3. Prior treatment with potential transient effects on the retina\n\n   * Recent retinal surgery\n   * Recent drug therapy affecting retinal structure or function\n   * Any acute intervention that might confound the correlation analyses due to lack of a stable baseline",true,{"count":111,"type":20},200,"OBSERVATIONAL","This prospective, observational investigation seeks to delineate the interplay between chromatic vision deficits and both functional visual outcomes and anatomical retinal biomarkers in individuals affected by Inherited Retinal Dystrophies (IRDs). The study will recruit approximately 200 subjects, encompassing a heterogeneous population of IRD patients-spanning a range of genotypes and clinical severities-as well as control participants devoid of retinal pathology. All enrolled individuals will undergo a standardized battery of evaluations, including quantitative color vision assessment, best-corrected visual acuity (BCVA) determination, and advanced multimodal retinal imaging.\n\nThe principal aim is to characterize the relationship between impairments in color discrimination and morphologic disruptions within the outer retinal layers, with particular emphasis on the continuity and reflectivity of the ellipsoid zone (EZ)-historically referred to as the inner segment\u002Fouter segment (IS\u002FOS) junction-assessed through spectral-domain optical coherence tomography (SD-OCT). Further, the study will explore associations between chromatic perceptual deficits and underlying genetic mutations, mutation patterns specific to IRD subtypes, and the influence of patient age on the severity and progression of color vision loss.\n\nA key secondary objective is the clinical appraisal and validation of a novel diagnostic modality, the Moji Low-Vision Color Discrimination Test (Moji Test), which is specifically engineered to quantify residual color perception in individuals with advanced central visual impairment. The test's discriminatory capacity will be benchmarked against established color vision testing paradigms to assess its reliability, clinical sensitivity, and suitability for implementation in populations with severe visual acuity reduction.\n\nBy incorporating a genetically and phenotypically diverse IRD cohort, the study is designed to enable granular, stratified analyses that will refine the understanding of structural-functional correlations in hereditary retinal disease. The inclusion of a control group with preserved retinal architecture and normal color vision function will provide essential normative baselines for comparative evaluation and statistical inference.",[115,116,117,118,119,120,121,122,123,124],"Retinal Dystrophies","Color Vision Defects","Vision Disorders","Macular Degeneration","Achromatopsia","Optical Coherence Tomography (OCT)","Visual Acuity","Genotype","Mutation","Phenotype",[126,127,128,129,130,131],"observational","IRD","ultra low vision","inherited retinal disease","color vision","color test","2025-12-03",{"date":134,"type":35},"2025-12-10",{"date":136,"type":35},"2025-07-20",{"date":138,"type":20},"2027-09-28",{"name":41,"class":42},""]