[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Alvotech Swiss AG\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":62},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"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":19,"type":20},256,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"Diabetic Macular Edema","RECRUITING","2026-04-27",{"date":30,"type":31},"2026-04-30","ACTUAL",{"date":33,"type":31},"2026-04-22",{"date":35,"type":20},"2028-01",{"name":37,"class":38},"Alvotech Swiss AG","INDUSTRY",1,{"id":41,"slug":4,"hasResults":10,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":4},"100629507","NCT07475572","A Randomized, Double-Blind, Pharmacokinetic Similarity Study to Compare AVT32-DRL_PB With Keytruda® in Participants With Fully Resected Melanoma","A Multicenter, Randomized, Double-Blind, 2-Treatment Arm Study to Assess Comparative Pharmacokinetics, Efficacy, Safety and Immunogenicity Between Intravenous AVT32-DRL_PB and Keytruda® as an Adjuvant Treatment in Participants With Stage IIB\u002FC-III Melanoma Following Complete Resection","Inclusion Criteria:\n\n* Participants (male\u002Ffemale) ≥18 years of age at the time of signing the ICF.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at the time of enrollment.\n* Participants with Stage IIB, IIC, or III histologically confirmed cutaneous melanoma\n\nExclusion Criteria:\n\n* Have had a solid organ transplant or bone marrow (stem cell) transplant that used donor stem cells (allogenic).\n* Has received prior systemic anticancer therapy for melanoma including investigational agents.\n* Participants with a history of mucosal or uveal melanoma, even if diagnosis and treatment were completed \\>5 years ago.",{"count":47,"type":20},120,[49],"PHASE1","This is a multicenter, randomized, double-blind, parallel-group, 2 treatment group, repeated dose study to compare the PK, efficacy, safety, and immunogenicity of AVT32-DRL\\_PB (proposed Keytruda® biosimilar) versus Keytruda (pembrolizumab) when administered as monotherapy in participants with fully resected Stage IIB\u002FC or Stage III melanoma requiring adjuvant treatment with pembrolizumab. Eligible participants will be randomized in a 1:1 ratio to the AVT32-DRL\\_PB or Keytruda treatment group and stratified by sex (female versus male) and body weight category (≤75 kg versus \\>75 kg). Study treatments will be administered every 3 weeks (Q3W) as an intravenous (IV) infusion over 30 minutes (1 administration Q3W is 1 treatment cycle). The administered pembrolizumab dose will be 200 mg Q3W for both treatment groups.",[52],"Melanoma","NOT_YET_RECRUITING","2026-03-11",{"date":56,"type":31},"2026-03-16",{"date":58,"type":20},"2026-06-19",{"date":60,"type":20},"2028-04-14",{"name":37,"class":38},""]