[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630550":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":37,"responsibleParty":50,"collaborators":25,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":25,"enrollmentInfo":62,"targetDuration":25,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":25,"overallStatus":40,"whyStopped":25,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Alvotech Swiss AG","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AVT29 (proposed aflibercept HD biosimilar)","EXPERIMENTAL","Participants will receive 1 IVT injection of AVT29 at baseline and every 4 weeks for 2 consecutive monthly visits (at Week 4 and Week 8), followed by 1 IVT injection every 8 to 16 weeks based on DRM criteria through study completion.",[13],"Drug: AVT29 (proposed aflibercept HD biosimilar)",{"label":15,"type":16,"description":17,"interventionNames":18},"Eylea HD (aflibercept HD)","ACTIVE_COMPARATOR","Participants will receive 1 IVT injection of Eylea HD at baseline and every 4 weeks for 2 consecutive monthly visits (at Week 4 and Week 8), followed by 1 IVT injection every 8 to 16 weeks based on DRM criteria through study completion.",[19],"Drug: Eylea HD (aflibercept HD)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Patients will receive IVT injections of AVT29",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Patients will receive IVT injections of Eylea HD",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Silvia Cirillo","CONTACT","+41 78 659 89 89","alvotech.clinical@alvotech.com",{"name":36,"role":32,"phone":25,"phoneExt":25,"email":34},"Riken Soni",[38],{"facility":39,"status":40,"city":41,"state":25,"zip":25,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":25},"Site 3004","RECRUITING","Budapest","Hungary","HU",{"type":45,"coordinates":46},"Point",[47,48],19.04045,47.49835,{"lat":48,"lon":47},{"type":51,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100630550","phase-3-clinical-study-to-compare-efficacy-and-safety-of-avt29-and-eylea-hd-in-participants-with-diabetic-macular-edema-100630550",false,"NCT07489131","Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants With Diabetic Macular Edema","A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT29 Compared With Eylea HD in Participants With Diabetic Macular Edema","ALVOEYE-HD","Main Inclusion Criteria:\n\n* Participant is ≥18 years old at the time of signing the ICF.\n* Participant is willing and able to comply with all study procedures and likely to complete the study, based on the investigator's judgment.\n* Participant has a diagnosis of DME secondary to DM with central involvement in the study eye.\n* Participant has a BCVA ETDRS letter score of 73 to 34 letters inclusive (20\u002F40 to 20\u002F200 Snellen equivalent) in the study eye at screening and on Day 1 prior randomization.\n* Participant's decrease in vision is determined to be primarily the result of DME in the study eye.\n\nMain Exclusion Criteria:\n\n* previous treatment with anti-VEGF therapy\n* history or concurrent disease other than DME that could compromise visual acuity\n* Any condition that, in the Investigator ́s opinion, can interfere with full participation in the study, including administration of the study treatment and attending required visits; can pose a significant risk to the participant, or interfere with interpretation of study data\n* participants not suitable for participation, whatever the reason, as judged by the Investigator, including medical or psychiatric conditions, or participants potentially at risk of noncompliance to study procedures.","ALL","18 Years",{"count":63,"type":64},256,"ESTIMATED","INTERVENTIONAL",[67],"PHASE3","This is a Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT29 Compared with Eylea HD in Participants with Diabetic Macular Edema.",[70],"Diabetic Macular Edema","2026-04-27",{"date":73,"type":74},"2026-04-30","ACTUAL",{"date":76,"type":74},"2026-04-22",{"date":78,"type":64},"2028-01",{"name":5,"class":6},1]