[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561837":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":34,"locations":35,"responsibleParty":55,"collaborators":34,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":34,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":34,"enrollmentInfo":67,"targetDuration":34,"studyType":70,"phases":71,"briefSummary":74,"conditions":75,"keywords":79,"overallStatus":38,"whyStopped":34,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Isfahan University of Medical Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Case: Intravitreal injection of bevacizumab with oral curcumin","EXPERIMENTAL","Intravitreal injection of bevacizumab with oral curcumin Inclusion criteria: Patients with center-involving macular edema with macular center thickness of more than 300 microns in OCT 2-Patients who did not receive intravitreal bevacizumab in the last 3 months and intravitreal corticosteroids in the previous 6 months.\n\n3- The amount of BCVA should not be \\\u003C20\u002F400. 4-Consent to participate in the study",[13],"Drug: bevacizumab with oral curcumin",{"label":15,"type":16,"description":17,"interventionNames":18},"Control: Intravitreal injection of bevacizumab with oral placebo","PLACEBO_COMPARATOR","Intravitreal injection of bevacizumab with oral placebo",[19],"Drug: bevacizumab with oral placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","bevacizumab with oral curcumin","According to the recommendation of the American Association of Ophthalmologists, intravitreal injection of bevacizumab with a standard dose of 1.25mg\u002F0.05ml in each group will be performed three times consecutively at one-month intervals. In the simultaneous intervention group, patients will take daily curcumin tablets (sinacurcumin product) at a dose of 40 mg twice a day for three months (at the same time as the start of bevacizumab intravitreal injection treatment).",[9],[27],"intervention group",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"bevacizumab with oral placebo","Intravitreal injection of bevacizumab with a standard dose of 1.25mg\u002F0.05ml in each group will be performed three times consecutively at one-month intervals. In the control group, patients will be taking daily placebo tablets twice a day for three months (at the same time as the start of bevacizumab intravitreal injection treatment).",[15],[33],"placebo",null,[36],{"facility":37,"status":38,"city":39,"state":5,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Mohsen Pourazizi","RECRUITING","Isfahan","8174673461","Iran","IR",{"type":44,"coordinates":45},"Point",[46,47],51.67462,32.65246,{"lat":47,"lon":46},[50],{"name":51,"role":52,"phone":53,"phoneExt":34,"email":54},"Mohsen Pourazizi, Doctor","CONTACT","+983134452031","m.pourazizi@yahoo.com",{"type":56,"investigatorFullName":37,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Dr.Mohsen Pourazizi","100561837","phase-2-efficacy-and-safety-of-intravitreal-injection-of-bevacizumab-with-and-without-oral-curcumin-100561837",false,"NCT06595355","Efficacy and Safety of Intravitreal Injection of Bevacizumab with and Without Oral Curcumin","Efficacy and Safety of Intravitreal Injection of Bevacizumab with and Without Oral Curcumin in Diabetic Macular Edema","Inclusion Criteria:\n\nPatients with center-involving macular edema with macular center thickness more than 300 microns in OCT 2-Patients who did not receive intravitreal bevacizumab in the last 3 months and intravitreal corticosteroids in the last 6 months.\n\n3- The amount of BCVA should not be \\\u003C20\u002F400. 4-Consent to participate in the study\n\nExclusion Criteria:\n\n1. Other retinal diseases except for DME and macular edema due to other causes including uveitis, epiretinal membrane, central retinal vein occlusion, and...\n2. Existence of proliferative diabetic retinopathy and patients with a history of vitrectomy\n3. Patients with glaucoma, vitreous hemorrhage, age-related macular degeneration (ARMD)\n4. Media opacities that limit the interpretation of diagnostic tests\n5. Surgery or procedure 3 months before starting treatment\n6. Pregnancy or breastfeeding\n7. History of allergy to curcumin\n8. Use of warfarin\n9. Changing the patient's clinical diagnosis or the need for surgical interventions in the course of the disease\n10. Change in the patient's general health condition\n11. Absence of patient referrals\n12. Lack of consent to continue treatment and follow-up","ALL","40 Years",{"count":68,"type":69},52,"ESTIMATED","INTERVENTIONAL",[72,73],"PHASE2","PHASE3","The purpose of this study is to evaluate the effectiveness of adding curcumin oral treatment to bevacizumab intravitreal injection in patients with central macular edema.\n\nA blind study and a randomized and controlled clinical trial are conducted on diabetic patients with macular edema. The patients are divided into two intervention groups (bevacizumab + curcumin) and control (bevacizumab + placebo).\n\nThe evaluation of the central thickness of the macula and the evaluation of the central volume of the macula are the primary goals and the evaluation of the best visual acuity of the patient is the secondary goal.",[76,77,78],"Diabetic Macular Edema","Macular Edema","Retinal Neovascularization",[80,81,82,83,84,78],"macular edema","diabetic macular edema","central macular edema","bevacizumab","Diabetic Retinopathy","2024-09-10",{"date":87,"type":88},"2024-09-19","ACTUAL",{"date":90,"type":88},"2021-10-10",{"date":92,"type":69},"2025-09-22",{"name":5,"class":6},1]