[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"center-involved-diabetic-macular-edema\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:center-involved-diabetic-macular-edema":90},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100615676","micropulse-laser-in-treatment-of-initial-and-refractory-cases-of-center-involved-diabetic-macular-edema-100615676",false,"NCT07295704","Micropulse Laser in Treatment of Initial and Refractory Cases of Center-Involved Diabetic Macular Edema","Comparative Evaluation of Micropulse Laser in Treatment of Initial and Refractory Cases of Center-Involved Diabetic Macular Edema","Inclusion Criteria:\n\n* Age ≥18 years.\n* Both sexes.\n* Patients with type 1 or 2 diabetes mellitus (DM), best-corrected visual acuity (BCVA) of 20\u002F400 or better, and center-involved DME \\[defined as a central macular thickness (CMT) of \\>250 but \\\u003C700µm measured by spectral-domain optical coherence tomography\\].\n* Patients with any level of non-proliferative diabetic retinopathy or proliferative diabetic retinopathy with adequate panretinal photocoagulation (PRP) and no signs of disease activity determined by fluorescein angiography (FA).\n\nExclusion Criteria:\n\n* Monocular eyes.\n* Chronic renal failure or renal transplant because of diabetic nephropathy.\n* Glycated hemoglobin (HbA1c) of more than 10%.\n* Vitreomacular traction syndrome.\n* Epiretinal membrane.\n* PRP within 4months before the treatment.\n* Intraocular surgery within 6months, including cataract or vitreoretinal operation.\n* Rubeosis iridis.\n* Severe glaucoma.\n* High-risk proliferative diabetic retinopathy.\n* Poor dilation.\n* Increased foveal avascular zone.\n* Any condition that could interfere with optical coherence tomography (OCT) measurement or visual acuity.","ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","OBSERVATIONAL","This study aims to evaluate the effect of subthreshold 577 nm micropulse laser photocoagulation in the treatment of initial and refractory cases of Center-Involved Diabetic Macular Edema.",[24,25,26,27,28],"Micropulse Laser","Treatment","Initial","Refractory","Center-Involved Diabetic Macular Edema","RECRUITING","2025-12-06",{"date":32,"type":33},"2025-12-22","ACTUAL",{"date":35,"type":33},"2025-10-15",{"date":37,"type":20},"2026-03-30",{"name":39,"class":40},"The General Authority for Teaching Hospitals and Institutes","NETWORK",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100500905","phase-1-phase-i-study-to-assess-the-safety-and-efficacy-of-ocu200-for-center-involved-diabetic-macular-edema-dme-100500905","NCT05802329","Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)","A Phase 1 Study To Assess The Safety And Efficacy Of OCU200 For Center-Involved Diabetic Macular Edema","DME","Inclusion Criteria:\n\n1. Diagnosis of Type 1 or Type 2 Diabetes Mellitus\n2. Decreased visual acuity attributable primarily to DME\n3. Central-involved DME with central retinal subfield thickness (CST) values, as assessed with spectral-domain optical coherence tomography (SD-OCT) of:\n\n   1. ≥ 320 but ≤ 450µm if male or ≥ 305 but ≤ 435µm if female on Heidelberg Spectralis\n   2. ≥ 305 but ≤ 435µm if male or ≥ 290 but ≤ 420µm if female on Zeiss Cirrus\n4. BCVA ≤ 78 and ≥ 24 letters on ETDRS chart\n5. Sufficient ocular media clarity, pupillary dilation and participant cooperation to permit acquisition of good quality retinal imaging\n6. No history of prior anti-VEGF injection or history of at least 2 consecutive intravitreal anti-VEGF injection (less than 7 weeks apart) with incomplete resolution of CST within 1 year.\n\nNote: The last anti-VEGF injection must be administered at least six weeks (45 days) prior to the study treatment (Day 1) in the study eye.\n\nExclusion Criteria:\n\n1. Presence of any condition that prevent clear visualization of retina (e.g., significant cataract, vitreous hemorrhage)\n2. Uncontrolled hypertension\n3. Uncontrolled glaucoma\n4. Concurrent disease in the study eye, other than central-involved DME\n5. Intravitreal or periocular steroid treatment within 3 months prior to the screening visit\n6. Any ocular surgery within 3 months prior to the screening visit in the study eye\n7. Uncontrolled\u002Fpoorly controlled diabetes (Glycated hemoglobin (HbA1c) ≥ 10%)\n8. History of retinal detachment in the study eye or other retinal vascular disease in the study eye\n9. Focal or pan-retinal laser photocoagulation in the study eye within 3 months prior to the screening visit\n10. Presence of any inherited retinal disease or history of proliferative diabetic retinopathy\n11. History of Renal disease including stage 3b or worse",true,{"count":52,"type":20},24,"INTERVENTIONAL",[55],"PHASE1","A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema",[58,59],"Center Involved Diabetic Macular Edema","Diabetic Macular Edema",[61,62,63,48],"anti-VEGF","Transferrin","Tumstatin","2025-11-25",{"date":66,"type":33},"2025-12-03",{"date":68,"type":33},"2024-01-13",{"date":70,"type":20},"2026-07-31",{"name":72,"class":73},"Ocugen","INDUSTRY",5,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":53,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":41},"100581042","phase-2-randomized-clinical-trial-to-evaluate-the-effect-of-dapagliflozin-in-patients-with-diabetic-macular-edema-100581042","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","85 Years",{"count":85,"type":20},56,[87],"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?",[59,90],"Center-involved Diabetic Macular Edema",[59,92,93,94,95,96,97,98],"center-involved diabetic macular edema","Anti-VEGF","Aflibercept","EYLEA","Dapagliflozin","Forxiga","SGLT2 inhibitor","2025-06-16",{"date":101,"type":33},"2025-06-19",{"date":103,"type":33},"2025-02-08",{"date":105,"type":20},"2026-08",{"name":107,"class":108},"Alexandria University","OTHER"]