[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591776":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":45,"centralContacts":50,"locations":60,"responsibleParty":89,"collaborators":30,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":100,"maxAge":30,"enrollmentInfo":101,"targetDuration":30,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":116,"overallStatus":63,"whyStopped":30,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"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",[61,79],{"facility":62,"status":63,"city":64,"state":30,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Sahlgrenska University Hospital, Department of Ophthalmology","RECRUITING","Mölndal","431 80","Sweden","SE",{"type":69,"coordinates":70},"Point",[71,72],12.01378,57.6554,{"lat":72,"lon":71},[75],{"name":76,"role":53,"phone":77,"phoneExt":78,"email":59},"Sofia T Silfverswärd, PhD, MSc","+46761283085","+46",{"facility":80,"status":81,"city":64,"state":30,"zip":82,"country":66,"countryCode":67,"cosmosGeoPoint":83,"geoPoint":85,"contacts":86},"Ögonmottagning Mölndal\u002FSU","NOT_YET_RECRUITING","43130",{"type":69,"coordinates":84},[71,72],{"lat":72,"lon":71},[87,88],{"name":52,"role":53,"phone":54,"phoneExt":30,"email":30},{"name":57,"role":53,"phone":77,"phoneExt":30,"email":59},{"type":90,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100591776","evaluation-of-serum--and-oct-biomarkers-in-patients-with-dme-treated-with-anti-vegf-or-dexamethasone-implant-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":102,"type":103},150,"ESTIMATED","INTERVENTIONAL",[106],"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).",[109,110,111,112,113,114,115],"Diabetic Macular Edema","Visual Impairment","Diabetes Mellitus","Hyperglycaemia (Diabetic)","Oxidative Stress","Vascular Endothelial Growth Factor","VEGF",[117],"optical coherence tomography","2025-11-17",{"date":120,"type":121},"2025-11-21","ACTUAL",{"date":123,"type":121},"2025-08-01",{"date":125,"type":103},"2028-12-31",{"name":5,"class":6},2]