[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626765":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":27,"locations":33,"responsibleParty":72,"collaborators":26,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":26,"enrollmentInfo":84,"targetDuration":26,"studyType":87,"phases":88,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":36,"whyStopped":26,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Ray Therapeutics, Inc.","INDUSTRY",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Low Dose RTx-021","EXPERIMENTAL","Intravitreal injection using gene therapy to deliver an optogenetic gene to the eye. Cells in the retina use this optogenetic gene to make a protein that responds to light.",[13],"Genetic: RTx-021",{"label":15,"type":10,"description":11,"interventionNames":16},"Middle Dose RTx-021",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"High Dose RTx-021",[13],[21],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"GENETIC","RTx-021","Optogenetic gene therapy",[18,9,15],null,[28],{"name":29,"role":30,"phone":31,"phoneExt":26,"email":32},"Executive Clinical Director","CONTACT","858-617-8610","clinicaltrials@raytherapeutics.com",[34,48,63],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":26},"RayTx Clinical Site","RECRUITING","Bakersfield","California","93309","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-119.01871,35.37329,{"lat":46,"lon":45},{"facility":49,"status":36,"city":50,"state":51,"zip":52,"country":40,"countryCode":41,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"UPMC Vision Institute","Pittsburgh","Pennsylvania","15219",{"type":43,"coordinates":54},[55,56],-79.99589,40.44062,{"lat":56,"lon":55},[59],{"name":60,"role":30,"phone":61,"phoneExt":26,"email":62},"UPMC Vision Institute Clinical Trials Team","412-642-7888","Clinicaltrialsoph@upmc.edu",{"facility":35,"status":36,"city":64,"state":65,"zip":66,"country":40,"countryCode":41,"cosmosGeoPoint":67,"geoPoint":71,"contacts":26},"Bellaire","Texas","77401",{"type":43,"coordinates":68},[69,70],-95.45883,29.70579,{"lat":70,"lon":69},{"type":73,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100626765","phase-1-phase-12-open-label-dose-escalation-study-to-evaluate-safety-of-a-single-intravitreal-injection-of-rtx-021-in-patients-with-stargardt-disease-100626765",false,"NCT07439887","Phase 1\u002F2 Open-Label Dose-Escalation Study to Evaluate Safety of a Single Intravitreal Injection of RTx-021 in Patients With Stargardt Disease","Phase 1\u002F2, Open-Label, Dose-Escalation Study to Evaluate Safety of a Single Intravitreal Injection of RTx-021 in Patients With Stargardt Disease (AURORA)","AURORA","Inclusion Criteria:\n\n* Male and female patients \\>= 16 years of age\n* Able to comply with the study visit schedule and all protocol assessments\n* Diagnosis of Stargardt Disease (genetic testing required)\n* Study eye and fellow eye Best Corrected Visual Acuity meeting study criteria\n* Presence of retinal ganglion cells and\u002For retinal nerve fiber layer on Spectral Domain Optical Coherence Tomography testing at Screening confirmed by central image reading center\n* Adequate organ function and general good health\n\nExclusion Criteria:\n\n* Participation in a clinical study (ocular or non-ocular) with an investigational drug, agent, or therapy in the past six months\n* Concurrent participation in another interventional clinical ocular study\n* Prior receipt of any gene therapy (ocular or other), retinal implant, or ocular cell therapy\n* Pre-existing eye conditions in either eye that would preclude the planned treatment or are significant enough to interfere with the interpretation of study endpoints or procedural complications\n* Known steroid responders if their intraocular pressure was not able to be managed effectively with topical pressure-lowering medications after prior use of steroid medications\n* Complicating systemic diseases including those in which the disease itself, or the treatment of the disease, can alter ocular and\u002For central nervous system function (e.g. radiation treatment of the orbit; leukemia with optic nerve involvement)\n* Any immunological response dysfunction including, immuno-compromising diseases or use of immunosuppressive medications, among others\n* Cataract or other ocular (including refractive) surgery, intraocular and\u002For peri-ocular injection in either eye within the prior four months (i.e. 120 days) prior to screening\n* Prior vitrectomy or aphakia in the study eye\n* Known sensitivity to any component of the study treatment or contraindication to medications planned for use in the peri-procedural period (e.g. povidone-iodine to prep for intravitreal injection)\n* Known contraindication to prophylactic steroid regimen\n* Current pregnancy or breastfeeding\n* Any other condition that would not allow the patient to complete follow-up examinations during the study","ALL","16 Years",{"count":85,"type":86},18,"ESTIMATED","INTERVENTIONAL",[89,90],"PHASE1","PHASE2","A Phase 1\u002F2, open-label, non-randomized, dose-escalation study, where a minimum of 9 and a maximum of 18 eligible patients with Stargardt Disease will be enrolled sequentially in up to 3 dose cohorts of RTx-021. Enrolled patients will receive a single, unilateral intravitreal injection of RTx-021 in the study eye and be followed for 5 years.",[93],"Stargardt Disease",[80,23],"2026-04-13",{"date":97,"type":98},"2026-04-15","ACTUAL",{"date":100,"type":98},"2026-01-28",{"date":102,"type":86},"2030-12-01",{"name":5,"class":6},3]