[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581042":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":46,"responsibleParty":77,"collaborators":44,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":44,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":49,"whyStopped":44,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Alexandria University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group","EXPERIMENTAL","The treatment group will receive oral dapagliflozin 10 mg daily in addition to standard of care intravitreal aflibercept injections.",[13,14],"Drug: Dapagliflozin","Drug: Anti-VEGF drug",{"label":16,"type":17,"description":18,"interventionNames":19},"Control group","ACTIVE_COMPARATOR","The control group will receive standard of care intravitreal aflibercept injections.",[14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Dapagliflozin","Dapagliflozin 10 mg will be given orally once daily for three months.",[9],[27],"Forxiga 10 mg",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Anti-VEGF drug","Aflibercept 2 mg (0.05 ml) will be administered by intravitreal injection every month for three consecutive months.",[16,9],[33],"Aflibercept (Eylea)",[35],{"name":36,"affiliation":37,"role":38},"Amira A. Nayel, MSc","Clinical researcher and PhD student at the Faculty of Pharmacy, Alexandria University","PRINCIPAL_INVESTIGATOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Amira A. Nayel, Pharm.D, MSc","CONTACT","+201022715779",null,"gs-amira.nayel@alexu.edu.eg",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":44,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Alexandria Main University Hospital, The Ophthalmology Department, Faculty of Medicine, Alexandria University","RECRUITING","Alexandria","Alexandria Governorate","Egypt","EG",{"type":55,"coordinates":56},"Point",[57,58],29.91582,31.20176,{"lat":58,"lon":57},[61,65,67,69,71,73,74],{"name":62,"role":42,"phone":63,"phoneExt":44,"email":64},"Hesham Elgoweini, PhD","+201287740750","ethics.comm@alexmed.edu.eg",{"name":66,"role":38,"phone":44,"phoneExt":44,"email":44},"Ahmed I. ElMallah, PhD",{"name":68,"role":38,"phone":44,"phoneExt":44,"email":44},"Noha A. Hamdy, PhD",{"name":70,"role":38,"phone":44,"phoneExt":44,"email":44},"Islam S. Ahmed, PhD",{"name":72,"role":38,"phone":44,"phoneExt":44,"email":44},"Mai H. Badra, PhD",{"name":41,"role":38,"phone":44,"phoneExt":44,"email":44},{"name":75,"role":76,"phone":44,"phoneExt":44,"email":44},"Mohamed A. El-Massry, PhD","SUB_INVESTIGATOR",{"type":78,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100581042","phase-2-randomized-clinical-trial-to-evaluate-the-effect-of-dapagliflozin-in-patients-with-diabetic-macular-edema-100581042",false,"NCT06845163","Randomized Clinical Trial to Evaluate the Effect of Dapagliflozin in Patients With Diabetic Macular Edema","Clinical Study on the Efficacy of Oral Dapagliflozin Combined With Intravitreal Injection of Anti-Vascular Endothelial Growth Factor in Patients With Diabetic Macular Edema","DAPA-DME","Inclusion criteria:\n\n* Type II diabetes mellitus patients, treated with premixed insulin and metformin, and diagnosed with center-involved diabetic macular edema (CiDME)\n* Presence of retinal thickening involving the center of the fovea (CiDME) in the study eye on Optical Coherence Tomography (OCT) Heidelberg Spectralis; If both eyes are eligible, the eye with the greater central subfield thickness on OCT is selected as the study eye.\n* Decreased visual acuity primarily attributable to DME\n* Clear ocular media and pupillary dilation for adequate retinal imaging\n* Ability to understand the study procedures and willingness to provide written informed consent\n\nStudy participant exclusion criteria:\n\n* Patients below 18 years old and patients above 85 years old\n* Patients with type I diabetes mellitus (Insulin dependent diabetes mellitus IDDM)\n* Pregnant women and lactating women diagnosed with diabetes or intending to become pregnant in the next 12 months\n* Patients who had myocardial infarction within 3 months prior to screening\n* Patients who had transient ischemic attack (TIA), ischemic or hemorrhagic stroke within 3 months prior to screening\n* Patients with poorly controlled diabetes mellitus, defined as patients having glycosylated hemoglobin (HbA1c) level of ≥12% at screening or patients who were hospitalized for diabetic ketoacidosis or hyperosmolar coma within 4 months prior to screening\n* Patients with estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m2 at screening\n* Patients with severe hepatic impairment of Child-Turcotte-Pugh class C at screening\n* Patients treated with antidiabetic drugs thiazolidinediones (TZD) (rosiglitazone and pioglitazone) prior to screening\n* Patients who were receiving SGLT2 inhibitors (e.g., dapagliflozin, canagliflozin, or empagliflozin) within 3 months prior to screening\n* Known allergy or hypersensitivity to any component of the study drugs\n* Current or previous participation in another clinical study involving the systemic or ocular administration of an investigational drug or device within 6 months of screening\n\nStudy eye exclusion criteria:\n\n* Macular edema caused by other conditions than diabetic macular edema or coexisting with DME such as retinal vein occlusion, choroidal neovascularization (CNV), or uveitic cystoid macular edema\n* History of postoperative cystoid macular edema (Irvine-Gass syndrome)\n* Cataract extraction within 3 months prior to screening\n* Patients who had previous macular laser treatment\n* Patients who had peripheral panretinal photocoagulation laser (PRP) treatment within 6 months prior to screening\n* Patients who have been treated with intravitreal anti-VEGF or intravitreal corticosteroids within 6 months prior to screening\n* The use of corticosteroids or non-steroidal anti-inflammatory eye drops within 1 month prior to screening\n* Patients on topical prostaglandin analogs (e.g., latanoprost, travoprost, ioprost, or tafluprost) at screening\n* History of vitrectomy or scleral buckling\n* Presence of diffuse vitreomacular traction or thick epiretinal membrane on OCT causing significant traction\n* Presence of tractional retinal detachment involving the macula and requiring vitrectomy\n* Presence of other associated macular pathology (e.g., macular scars or macular holes) on OCT\n* Presence of rubeosis iridis\n* Signs of hypertensive retinopathy (arterioral spasm or silver wiring of blood vessels)\n* Presence of glaucoma\n* Aphakia\n* Yttrium aluminum garnet (YAG) laser capsulotomy within 3 months prior to screening\n* Patients diagnosed with ocular surface infections until treated prior to receiving the intravitreal injections\n\nNon-study eye exclusion criteria:\n\n• The non-study eye receiving simultaneous intravitreal anti-VEGF treatment with the study eye","ALL","18 Years","85 Years",{"count":91,"type":92},56,"ESTIMATED","INTERVENTIONAL",[95],"PHASE2","The purpose of this clinical study is to explore the efficacy of dapagliflozin as an adjunct to intravitreal anti-vascular endothelial growth factor (anti-VEGF) for enhanced reduction of retinal thickness and vision improvement in patients with diabetic macular edema. The main question the study aims to answer is: Does dapagliflozin reduce the thickness of the macula when combined with the standard of care intravitreal anti-VEGF therapy more than the intravitreal anti-VEGF therapy alone?",[98,99],"Diabetic Macular Edema","Center-involved Diabetic Macular Edema",[98,101,102,103,104,23,105,106],"center-involved diabetic macular edema","Anti-VEGF","Aflibercept","EYLEA","Forxiga","SGLT2 inhibitor","2025-06-16",{"date":109,"type":110},"2025-06-19","ACTUAL",{"date":112,"type":110},"2025-02-08",{"date":114,"type":92},"2026-08",{"name":5,"class":6},1]