[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657831":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":20,"interventions":26,"overallOfficials":13,"centralContacts":35,"locations":41,"responsibleParty":60,"collaborators":13,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":13,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":13,"enrollmentInfo":73,"targetDuration":13,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":13,"overallStatus":44,"whyStopped":13,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Vanderbilt University Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"To measure aqueous IL-6, IL-8, FLT-3L, FGF-2, and IL-10 before and after treatment with intravitreal corticosteroid.","We believe the above cytokines drive the formation of DME and that the therapeutic effects upon DME by corticosteroids are due to reduction of cytokine levels.","12 months",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","SINGLE_GROUP","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE",[21],{"label":22,"type":23,"description":13,"interventionNames":24},"intravitreal corticosteroid implant","ACTIVE_COMPARATOR",[25],"Drug: Intravitreal dexamethasone implant",[27,32],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":13},"DRUG","Intravitreal dexamethasone implant","intravitreal dexamethasone 0.7mg implant",[22],{"type":28,"name":29,"description":33,"armGroupLabels":34,"otherNames":13},"fluocinolone acetonide 0.19mg implant",[22],[36],{"name":37,"role":38,"phone":39,"phoneExt":13,"email":40},"Stephen J Kim, MD","CONTACT","615-936-2020","lindsay.veach@vumc.org",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Vanderbilt Eye Institute","RECRUITING","Nashville","Tennessee","37232","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-86.78444,36.16589,{"lat":54,"lon":53},[57],{"name":58,"role":38,"phone":59,"phoneExt":13,"email":40},"Lindsay Veach","6154218216",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Stephen J. Kim, MD","Professor of Ophthalmology & Visual Sciences","100657831","phase-4-corticosteroid-for-diabetic-macular-edema-dme-study-100657831",false,"NCT07843849","Corticosteroid for Diabetic Macular Edema (DME) Study","Inclusion Criteria:\n\n* Adult patients age 18 years or older with type II diabetes, with baseline moderate NPDR and DME.\n\nExclusion Criteria:\n\n* Patients with a history of previous vitrectomy in either eye; prior antivegf intravitreal injection within 3 months; co-existent non diabetic macular, retinovascular, or inflammatory disease; history of ocular trauma; aphakia; presence of an anterior chamber intraocular lens; current use of prescription systemic NSAIDs or regular use of nonprescription NSAIDs including aspirin (defined as 4 days or more a week for at least 2 weeks a month); blood pressure \\> 180\u002F110 mmHg; risk for corneal melting; and inability to comply with follow-up.",true,"ALL","18 Years",{"count":74,"type":75},20,"ESTIMATED","INTERVENTIONAL",[78],"PHASE4","Our current goals include confirming inflammation mediators are biomarkers of DR and DME\n\nThe Aim of this project is to measure aqueous PGE2 and inflammatory cytokines before and after treatment of DME with intravitreal corticosteroid injections.\n\nWe want to continue the study for one more year as our initial data analysis from the original INSPIRE study shows a possible direct correlation between aqueous biomarkers and DME. We propose treating the DME with corticosteroid to assess the effect upon the intraocular cytokines with inflammation is suppressed.",[81,82],"Diabetic Macular Edema (DME)","Diabetic Retinopathy","2026-09-21",{"date":85,"type":86},"2026-09-28","ACTUAL",{"date":88,"type":86},"2026-04-07",{"date":90,"type":75},"2029-03",{"name":5,"class":6},1]