[{"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:":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":20,"type":21},256,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Diabetic Macular Edema","RECRUITING","2026-04-27",{"date":31,"type":32},"2026-04-30","ACTUAL",{"date":34,"type":32},"2026-04-22",{"date":36,"type":21},"2028-01",{"name":38,"class":39},"Alvotech Swiss AG","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":4},"100629507","phase-1-a-randomized-double-blind-pharmacokinetic-similarity-study-to-compare-avt32-drlpb-with-keytruda-in-participants-with-fully-resected-melanoma-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":49,"type":21},120,[51],"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.",[54],"Melanoma","NOT_YET_RECRUITING","2026-03-11",{"date":58,"type":32},"2026-03-16",{"date":60,"type":21},"2026-06-19",{"date":62,"type":21},"2028-04-14",{"name":38,"class":39},""]