[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Therini Bio Pty Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100570013","phase-1-a-study-intravitreal-thn391-in-diabetic-macular-oedema-secondary-to-non-proliferative-diabetic-retinopathy-100570013",false,"NCT06701721","A Study Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.","A Phase 1b Open-Label, Multiple Ascending Dose Study of the Safety, Tolerability, and Biological Activity of Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.","Inclusion Criteria:\n\n* Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity\n* 18 to 80 years of age (inclusive at the time of informed consent).\n* Diagnosis of Diabetic Macular Edema (DME)\n* Vision loss in the study eye\n\nExclusion Criteria:\n\n* Be pregnant or breastfeeding\n* Cataract surgery or any other previous ocular surgery in the study eye within 3 months before Screening\n* Any other condition except for DME that could affect interpretation of study assessments","ALL","18 Years","80 Years",{"count":20,"type":21},21,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","THN391-OPT-101 is a study assessing safety and preliminary efficacy of THN391 in patients with diabetic macular edema (DME) given as monotherapy.",[27,28],"Diabetic Macular Edema","Diabetic Retinopathy",[30,31],"Diabetic Macular Oedema","Non-proliferative Diabetic Retinopathy","RECRUITING","2026-06-30",{"date":35,"type":36},"2026-07-02","ACTUAL",{"date":38,"type":36},"2024-12-20",{"date":40,"type":21},"2027-05-31",{"name":42,"class":43},"Therini Bio Pty Ltd","INDUSTRY",7,""]