[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Frontera Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":175},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,44,69,90,110,132,155],{"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":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100553958","phase-1-gene-therapy-for-rpgr-gene-mutation-associated-x-linked-retinitis-pigmentosa-100553958",false,"NCT06492850","Gene Therapy for RPGR Gene Mutation-associated X-linked Retinitis Pigmentosa","A Phase I\u002FII Dose-escalation and Dose-expansion Study to Evaluate the Safety and Efficacy of FT-002 Subretinal Injection in Subjects With RPGR Gene Mutation-associated X-linked Retinitis Pigmentosa.","Inclusion Criteria:\n\n* Subjects that are willing and able to follow study procedures including scheduled visits, treatment plan, and laboratory tests, and sign a written informed consent form;\n* Age: Phase I dose escalation stage, 18-45 years old male (including boundary value) at the time of signing the ICF; Phase II dose extension stage, males 8-45 years old (including boundary values) at the time of signing the ICF;\n* Clinically diagnosed XLRP, the main symptoms include but are not limited to night blindness, visual field loss, vision loss, etc.;\n\nExclusion Criteria:\n\n* Have other retinal degenerative diseases, such as retinal degeneration caused by other known Inherited retinal disease gene variants or previously received an gene therapy product.","MALE","8 Years","45 Years",{"count":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The aim of this study was to evaluate the safety, tolerability, and efficacy of one-time subretinal injection of FT-002 in male subjects (8-45 years of age) with RPGR (Retinitis Pigmentosa GTPase Regulator) gene mutation-associated X-linked retinitis pigmentosa, of XLRP. This study includes Phase I (dose escalation phase) and Phase II (dose expansion phase).",[28],"X-Linked Retinitis Pigmentosa (XLRP)",[28,30],"FT-002","RECRUITING","2024-07-01",{"date":34,"type":35},"2024-07-09","ACTUAL",{"date":37,"type":35},"2024-04-01",{"date":39,"type":21},"2026-02-01",{"name":41,"class":42},"Frontera Therapeutics","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":43},"100553959","phase-1-gene-therapyft-003-for-wet-amd-100553959","NCT06492863","Gene Therapy(FT-003) for Wet AMD","A Dose-escalation and Dose-expanded Phase I\u002FII Clinical Study to Evaluate the Safety, and Efficacy of FT-003 in Subjects With Wet AMD","Inclusion Criteria:\n\n* Subjects that are willing and able to follow study procedures;\n* Female or male patients 50-80 years old at the time of signing the ICF;\n* Clinically diagnosed with nAMD;\n* Presence of active CNV\n* The best corrected visual acuity (BCVA) of the studied eye is 24-73 letters;\n\nExclusion Criteria:\n\n* •Presence of any other intraocular diseases other than nAMD in the studied eye that would affect the improvement of visual acuity and require treatment during the study for prevention or treatment of visual loss, as judged by the investigator.","ALL","50 Years","80 Years",{"count":55,"type":21},78,[24,25],"The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of disposable vitreous injection of FT-003 in subjects with neovascular age-related Macular Degeneration (nAMD). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.",[59],"Neovascular Age-related Macular Degeneration",[61,62],"FT-003","nAMD",{"date":34,"type":35},{"date":65,"type":35},"2023-08-15",{"date":67,"type":21},"2028-10-15",{"name":41,"class":42},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":51,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":43},"100553960","phase-1-gene-therapy-for-dme-100553960","NCT06492876","Gene Therapy for DME","A Dose-escalation and Dose-expanded Phase I\u002FII Clinical Study to Evaluate the Safety, and Efficacy of FT-003 in Subjects With DME","Inclusion Criteria:\n\n* Subjects that are willing and able to follow study procedures;\n* Female or male patients 18-74 years old at the time of signing the ICF;\n* Clinically diagnosed with CI-DME;\n* The best corrected visual acuity (BCVA) of the studied eye is 24-73 letters;\n\nExclusion Criteria:\n\n* Presence of any other intraocular diseases other than DME in the studied eye that would affect the improvement of visual acuity and require treatment during the study for prevention or treatment of visual loss, as judged by the investigator.","18 Years","74 Years",{"count":55,"type":21},[24,25],"The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of disposable vitreous injection of FT-003 in subjects with Diabetic Macular Edema (DME). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.",[82],"Diabetic Macular Edema",[82,61],{"date":34,"type":35},{"date":86,"type":35},"2023-11-15",{"date":88,"type":21},"2028-11-15",{"name":41,"class":42},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":51,"minAge":76,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":43},"100509666","phase-1-gene-therapy-for-diabetic-macular-edema-100509666","NCT05916391","Gene Therapy for Diabetic Macular Edema","An Open-label, Multy-center, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FT-003 in Subjects With Diabetic Macular Edema","Inclusion Criteria:\n\n* Subjects that are willing and able to follow study procedures;\n* Female or male patients ≥18 years old at the time of signing the ICF;\n* Clinically diagnosed with CI-DME\n* HbA1c≤10%\n* The best corrected visual acuity (BCVA) of the studied eye is ≤ 73 letters\n\nExclusion Criteria:\n\n* Presence of any other intraocular diseases other than CI-DME in the studied eye that would affect the improvement of visual acuity and require treatment during the study for prevention or treatment of visual loss, as judged by the investigator",{"count":98,"type":21},18,[24],"FT-003 is a gene therapy product developed for the treatment of central involvement diabetic macular edema (CI-DME). Diabetic retinopathy is one of the most common microvascular complications of diabetes mellitus, and diabetic macular edema is the main cause of vision loss in patients with diabetic retinopathy. In the latest guidelines, anti-VEGF therapy is preferred for CI-DME. Administration of FT-003 has the potential to treat CI-DME by providing intraocular protein which is durable expressed in therapeutic level. FT-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with CI-DME receiving anti-VEGF therapy in clinical practice.",[82],"2023-06-14",{"date":104,"type":35},"2023-06-23",{"date":106,"type":35},"2023-05-19",{"date":108,"type":21},"2028-05-01",{"name":41,"class":42},{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},"100506432","early-phase-1-gene-therapy-for-subjects-with-rpgr-mutation-associated-x-linked-retinitis-pigmentosa-100506432","NCT05874310","Gene Therapy for Subjects With RPGR Mutation-associated X-linked Retinitis Pigmentosa","An Open-label, Single-center, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intraocular Administration of FT-002 in Subjects With RPGR Mutation-associated X-linked Retinitis Pigmentosa.","Inclusion Criteria:\n\n1.Subjects that are willing and able to follow study procedures; 2.Males aged 8-45 years old at the time of signing the Informed Consent Form; 4.Subjects who are confirmed with variants of RPGR ;\n\nExclusion Criteria:\n\n1.Have other retinal degenerative diseases, such as retinal degeneration caused by other known Inherited retinal disease gene variants or previously received an gene therapy product.",{"count":98,"type":21},[119],"EARLY_PHASE1","A clinical trial of gene therapy for patients with X-linked retinitis pigmentosa (XLRP).",[122],"X-Linked Retinitis Pigmentosa","2023-05-23",{"date":125,"type":35},"2023-05-24",{"date":127,"type":35},"2023-02-01",{"date":129,"type":21},"2027-11-01",{"name":41,"class":42},2,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":18,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":43},"100505255","phase-1-gene-therapy-in-subjects-with-biallelic-rpe65-mutation-associated-retinal-dystrophy-100505255","NCT05858983","Gene Therapy in Subjects With Biallelic RPE65 Mutation-associated Retinal Dystrophy","A Multi-center, Open-label, Dose-escalation Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability and Efficacy of FT-001 Administered Via Subretinal Injection in Subjects With Biallelic RPE65 Mutation-associated Retinal Dystrophy","Inclusion Criteria:\n\n1. Subjects who are able to understand and sign the ICF\n2. Female or male aged 8-45 years old when signing the ICF\n3. Clinically diagnosed with biallelic RPE65 mutation-associated retinal dystrophy\n\nExclusion Criteria:\n\n1. Other interfering eye diseases\n2. Presence of any systemic or ocular disease that can cause or likely to cause vision loss\n3. There is evidence of obviously uncontrolled concomitant diseases\n4. Known to have active or suspected autoimmune diseases\n5. With active systemic infection under treatment\n6. Pregnant or lactating women\n7. Other conditions unsuitable for the study as determined by the investigator",{"count":140,"type":21},9,[24,25],"The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of subretinal administration of FT-001 in subjects with biallelic RPE65 mutation-associated retinal dystrophy.",[144],"Biallelic RPE65 Mutation-associated Retinal Dystrophy",[146,144],"FT-001","2023-05-11",{"date":149,"type":35},"2023-05-15",{"date":151,"type":35},"2022-11-30",{"date":153,"type":21},"2029-11-30",{"name":41,"class":42},{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":51,"minAge":18,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":163,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":166,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":4},"100486234","phase-1-gene-therapy-for-wet-amd-100486234","NCT05611424","Gene Therapy for Wet AMD","An Open-label, Single-center, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FT-003 in Subjects With Neovascular Age-related Macular Degeneration","Inclusion Criteria:\n\n* Subjects that are willing and able to follow study procedures;\n* Female or male patients ≥45 years old at the time of signing the ICF;\n* Clinically diagnosed with nAMD;\n* Presence of active CNV\n* The best corrected visual acuity (BCVA) of the studied eye is ≤ 53 letters;\n\nExclusion Criteria:\n\n• Presence of any other intraocular diseases other than nAMD in the studied eye that would affect the improvement of visual acuity and require treatment during the study for prevention or treatment of visual loss, as judged by the investigator.",{"count":98,"type":21},[24],"FT-003 is a gene therapy product developed for the treatment of neovascular age-related macular degeneration (nAMD). Neovascular AMD is the main cause of blindness among elderly individuals. The available therapies for treating nAMD require life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. Administration of FT-003 has the potential to treat nAMD by providing durable expression of therapeutic levels of intraocular protein and maintaining the vision of patients. FT-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.",[59],"NOT_YET_RECRUITING","2023-04-24",{"date":169,"type":35},"2023-04-26",{"date":171,"type":21},"2023-05-01",{"date":173,"type":21},"2027-12-30",{"name":41,"class":42},""]