[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647271":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":38,"centralContacts":42,"locations":42,"responsibleParty":43,"collaborators":42,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":42,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":42,"enrollmentInfo":54,"targetDuration":42,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":66,"whyStopped":42,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":42},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"MK-8748 Low Dose","EXPERIMENTAL","Participants receive 5 initial administrations of MK-8748 low dose every 4 weeks (Q4W), then continue to receive MK-8748 low dose every 8 weeks (Q8W) until week 48. After week 48, participants will be treated at intervals determined based on individualized response to treatment, up to week 100.",[13],"Drug: MK-8748",{"label":15,"type":10,"description":16,"interventionNames":17},"MK-8748 High Dose","Participants receive 5 initial administrations of MK-8748 high dose every 4 weeks (Q4W), then continue to receive MK-8748 high dose every 8 weeks (Q8W) until week 48. After week 48, participants will be treated at intervals determined based on individualized response to treatment, up to week 100.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Aflibercept 2 mg","ACTIVE_COMPARATOR","Participants receive 5 initial administrations of aflibercept 2 mg every 4 weeks (Q4W), then continue to receive aflibercept 2mg every 8 weeks (Q8W) until week 100.",[23],"Drug: Aflibercept",[25,33],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","MK-8748","Administered by intravitreal injection (IVT)",[15,9],[31,32],"EYE201","Tiespectus",{"type":26,"name":34,"description":28,"armGroupLabels":35,"otherNames":36},"Aflibercept",[19],[37],"Eylea",[39],{"name":40,"affiliation":5,"role":41},"Medical Director","STUDY_DIRECTOR",null,{"type":44,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100647271","phase-3-a-clinical-trial-of-mk-8748-compared-to-aflibercept-in-participants-with-diabetic-macular-edema-mk-8748-004-100647271",false,"NCT07705555","A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-004)","A Randomized, Double-Masked, Multicenter, 3-Arm, Pivotal Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal (IVT) MK-8748 Compared With Aflibercept (2 mg) in Participants With Diabetic Macular Edema (DME)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has Type 1 or Type 2 diabetes mellitus and a hemoglobin A1c (HbA1c) of ≤12%\n* Has a decrease in vision in the study eye determined by the Investigator to be primarily the result of diabetic macular edema (DME)\n* For participants who are treatment-naïve for DME, the diagnosis must have been made within 9 months of screening. For all treatment-experienced participants, the first treatment should have been no longer than 3 years prior to the Screening visit\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has had renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis or has renal failure anticipated to require hemodialysis or peritoneal dialysis at any time during the study\n* Has history of stroke (cerebral vascular accident) or myocardial infarction within 180 days to first dose of study intervention\n* Has newly diagnosed or previously untreated diabetes mellitus and initiated oral or injectable anti-diabetic medication within 3 months to first dose of study intervention\n* Has history of cataract surgery and\u002For minimally invasive glaucoma surgery in the study eye within 90 days of screening\n* Has any treatment for complications of cataract surgery with steroids or yttrium aluminum garnet (YAG) laser capsulotomy in the study eye within 90 days of screening\n* Has advanced or uncontrolled glaucoma in the study eye\n* Has any history of retinal detachment or treatment or surgery for retinal detachment in the study eye\n* Has active retinal disease other than the condition under investigation in the study eye\n* Has uncontrolled blood pressure at screening","ALL","18 Years",{"count":55,"type":56},960,"ESTIMATED","INTERVENTIONAL",[59],"PHASE3","Researchers are looking for new ways to treat diabetic macular edema (DME). In this trial, researchers want to learn if a trial medicine called MK-8748 can treat DME. An available standard (usual) treatment for DME is aflibercept. However, standard treatments such as aflibercept may not work for every person.\n\nThe main goal of this trial is to learn if MK-8748 works as well as aflibercept to treat DME.",[62,63],"Diabetic Retinopathy","Macular Edema",[65],"Diabetic Macular Edema (DME)","NOT_YET_RECRUITING","2026-07-10",{"date":69,"type":70},"2026-07-15","ACTUAL",{"date":72,"type":56},"2026-08-28",{"date":74,"type":56},"2029-10-31",{"name":5,"class":6}]