[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591776":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":45,"centralContacts":50,"locations":60,"responsibleParty":88,"collaborators":30,"id":90,"slug":30,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":91,"sex":97,"minAge":98,"maxAge":30,"enrollmentInfo":99,"targetDuration":30,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":114,"overallStatus":63,"whyStopped":30,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Vastra Gotaland Region","OTHER_GOV",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Anti-VEGF treated patients","EXPERIMENTAL","Patients with ongoing anti-VEGF treatment",[13],"Drug: Anti-VEGF treatment",{"label":15,"type":10,"description":16,"interventionNames":17},"Dexamethasone treated patients","Patients with ongoing Dexamethasone implant treatment",[18],"Device: Dexamethasone implant",{"label":20,"type":10,"description":21,"interventionNames":22},"Patients not previously treated for DME","Treatment-naive patients (neither anti-VEGF treatment nor Dexamethasone implant treatment)",[23],"Other: Treatment with intravitreal anti-VEGF OR Dexamethasone implant",[25,31,38],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Anti-VEGF treatment","Treatment with intravitreal anti-VEGF treatment",[9],null,{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DEVICE","Dexamethasone implant","Treatment with Dexamethasone implant",[15],[37],"Dexamethasone treatment",{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"OTHER","Treatment with intravitreal anti-VEGF OR Dexamethasone implant","Treatment with intravitreal anti-VEGF OR treatment with Dexamethasone implant",[20],[44],"Anti-VEGF OR Dexamethasone treatment",[46],{"name":47,"affiliation":48,"role":49},"Marita Grönlund, M.D. Prof","Göteborg University","PRINCIPAL_INVESTIGATOR",[51,56],{"name":52,"role":53,"phone":54,"phoneExt":30,"email":55},"Imadeddin Abu Ishkheidem, M.D.","CONTACT","+46738744867","imadeddin.abu.ishkheidem@vgregion.se",{"name":57,"role":53,"phone":58,"phoneExt":30,"email":59},"Sofia Töyrä Silfverswärd, PhD","0761283085","sofia.toyra.silfversward@vgregion.se",[61,78],{"facility":62,"status":63,"city":64,"state":30,"zip":65,"country":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Sahlgrenska University Hospital, Department of Ophthalmology","RECRUITING","Mölndal","431 80","Sweden",{"type":68,"coordinates":69},"Point",[70,71],12.01378,57.6554,{"lat":71,"lon":70},[74],{"name":75,"role":53,"phone":76,"phoneExt":77,"email":59},"Sofia T Silfverswärd, PhD, MSc","+46761283085","+46",{"facility":79,"status":80,"city":64,"state":30,"zip":81,"country":66,"cosmosGeoPoint":82,"geoPoint":84,"contacts":85},"Ögonmottagning Mölndal\u002FSU","NOT_YET_RECRUITING","43130",{"type":68,"coordinates":83},[70,71],{"lat":71,"lon":70},[86,87],{"name":52,"role":53,"phone":54,"phoneExt":30,"email":30},{"name":57,"role":53,"phone":76,"phoneExt":30,"email":59},{"type":89,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100591776",false,"NCT06984822","Evaluation of Serum- and OCT Biomarkers in Patients With DME Treated With Anti-VEGF or Dexamethasone Implant","Evaluation of Serum and Ocular Coherence Tomography Biomarkers in Patients With Diabetic Macular Edema Treated With Anti-VEGF or Dexamethasone Implant","BiomarkerOCT","Inclusion Criteria:\n\n* Type I or type II DM.\n* DME involving the center of the fovea with CFT more than 280 microns and the presence of intraretinal cysts.\n\nExclusion Criteria:\n\n* Prior history of any other macular disease.\n* Previous treatment with dexamethasone implants in the last six months for those in the anti-VEGF group.\n* Previous treatment with anti-VEGF in the last two months for those in the dexamethasone implant group.\n* Prior vitreoretinal surgery.\n* Previous laser treatment of the macula.\n* Previous panretinal photocoagulation.\n* Ocular surgery in the previous 3 months.","ALL","18 Years",{"count":100,"type":101},150,"ESTIMATED","INTERVENTIONAL",[104],"NA","This study aims to investigate the association between serum biomarkers and clinical response to anti-VEGF or dexamethasone implant by assessing OCT-biomarkers in patients with diabetic macular edema, DME, and to compare these with a group of naive patients (those not previously treated for DME).",[107,108,109,110,111,112,113],"Diabetic Macular Edema","Visual Impairment","Diabetes Mellitus","Hyperglycaemia (Diabetic)","Oxidative Stress","Vascular Endothelial Growth Factor","VEGF",[115],"optical coherence tomography","2025-11-17",{"date":118,"type":119},"2025-11-21","ACTUAL",{"date":121,"type":119},"2025-08-01",{"date":123,"type":101},"2028-12-31",{"name":5,"class":6},2]