[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581458":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":34,"locations":35,"responsibleParty":56,"collaborators":60,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":34,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":34,"enrollmentInfo":72,"targetDuration":34,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":34,"overallStatus":38,"whyStopped":34,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Al-Mustansiriyah University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Bevacizumab group","ACTIVE_COMPARATOR","Patients will receive an intravitreal injection of 1.25 mg (in 0.05 ml solution) of bevacizumab once monthly for three consecutive months.",[13],"Drug: Bevacizumab Injection [Avastin]",{"label":15,"type":16,"description":17,"interventionNames":18},"Aflibercept group","EXPERIMENTAL","Patients will receive an intravitreal injection of 2.0 mg (in 0.05 ml solution) of aflibercept once monthly for three consecutive months.",[19],"Drug: Aflibercept 2Mg\u002F0.05Ml Inj,Oph",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Bevacizumab Injection [Avastin]","1.25 mg intravitreal injection given once monthly for three consecutive months.",[9],[27],"Avastin 100 mg in 4 ml Injection",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Aflibercept 2Mg\u002F0.05Ml Inj,Oph","2.0 mg intravitreal injection given once monthly for three consecutive months.",[15],[33],"EYLEA Bayer",null,[36],{"facility":37,"status":38,"city":39,"state":34,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Baghdad Medical City Complex","RECRUITING","Baghdad","10001","Iraq","IQ",{"type":44,"coordinates":45},"Point",[46,47],44.40088,33.34058,{"lat":47,"lon":46},[50],{"name":51,"role":52,"phone":53,"phoneExt":54,"email":55},"Mahmood Salman, PhD","CONTACT","7905777486","00964","ph.mahmoudalrawi@uoanbar.edu.iq",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Mohammed Mahmood Mohammed","Principal Investigator",[61],{"name":62,"class":6},"Baghdad Medical City","100581458","phase-4-aflibercept-and-bevacizumab-for-diabetic-maculopathies-100581458",false,"NCT06850571","Aflibercept and Bevacizumab for Diabetic Maculopathies","Evaluation of the Clinical Outcomes and Cost-effectiveness of Aflibercept and Bevacizumab in Iraqi Patients With Diabetic Maculopathies: Open Label Parallel Groups Clinical Trial","Inclusion Criteria:\n\n* Patients with type 2 diabetes mellites.\n* Patients diagnosed with diabetic maculopathies, including focal and diffuse maculopathies, according to Early Treatment of Diabetic Retinopathy Study (ETDRS) criteria\n* Patients with reduced or reduced vision (6\u002F9-6\u002F90) according to visual acuity and significant foveolar thickening on OCT (more than 250 μm)\n* Patients will be treated with intravitreal anti-VEGF treatment, aflibercept, or bevacizumab for three successive monthly injections.\n\nExclusion Criteria:\n\n* Patients with type 1 diabetes mellites\n* Patients with type 2 on insulin therapy.\n* Patients who were previously treated with intravitreal anti-VEGF within the previous three months or intravitreal corticosteroids for six months\n* Prior macular photocoagulation or photodynamic therapy, prior intraocular surgeries within three months (laser \\& surgery may cause edema)\n* Pregnant or nursing women\n* In patients with a history of thromboembolic events, systemic VEGF inhibition is likely to cause cardiovascular complications, such as arterial thromboembolic events.\n* Patients major surgery within the previous one year or planned within the next few months that may interfere with anti-VEGF treatment\n* Uncontrolled hypertension as hypertension is associated with the use of VEGF antagonists.\n* Known coagulation abnormalities or current use of anticoagulative medication other than aspirin.\n* Hemorrhagic macular infarction is reported with the use of VEGF antagonists.\n* Patients with intraocular pressure more than 25 mmHg\n* Presence of iris neovascularization\u002Fvitreous hemorrhage","ALL","40 Years",{"count":73,"type":74},102,"ESTIMATED","INTERVENTIONAL",[77],"PHASE4","The goal of this clinical trial is to to evaluate the clinical outcomes following treatment with bevacizumab versus aflibercept. These outcomes include:\n\n* Functional changes: The visual outcomes achieved by testing visual acuity\n* Anatomical changes: macular thickness and edema by optical coherence tomography (OCT).",[80],"Diabetic Maculopathy","2025-09-18",{"date":83,"type":84},"2025-09-19","ACTUAL",{"date":86,"type":84},"2025-02-20",{"date":88,"type":74},"2025-12-01",{"name":5,"class":6},1]