[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657670":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":30,"studyPopulation":30,"armGroups":42,"interventions":53,"overallOfficials":30,"centralContacts":61,"locations":30,"responsibleParty":67,"collaborators":30,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":30,"enrollmentInfo":79,"targetDuration":30,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":94,"whyStopped":30,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":30},{"fullName":5,"class":6},"Ollin Biosciences, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Change in BCVA","Change in ETDRS BCVA eye chart letter score from Day 1 to Week 48.","Day 1 to Week 48",[14,18,21,25,27],{"measure":15,"description":16,"timeFrame":17},"Mean change in OCT CST in the Study Eye from baseline at Week 20","Difference in the mean change from baseline in OCT CST in the Study Eye between the OLN324 arm and the aflibercept arm","Day 1 to Week 20",{"measure":19,"description":20,"timeFrame":17},"Percentage of participants with absence of DME in the Study Eye at Week 20","Difference in the percentage of participants with absence of DME in the Study Eye between the OLN324 arm and the aflibercept arm",{"measure":22,"description":23,"timeFrame":24},"Time to DME resolution in the Study Eye","Difference in the time to first DME resolution in the Study Eye","Enrollment through study completion, an average of 2 years",{"measure":26,"description":16,"timeFrame":12},"Mean change in OCT CST in the Study Eye from baseline at Week 48",{"measure":28,"description":20,"timeFrame":29},"Percentage of participants with absence of DME in the Study Eye at Week 48","Week 48",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":36,"maskingDescription":30,"whoMasked":37},"QUADRUPLE",[38,39,40,41],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[43,48],{"label":44,"type":45,"description":30,"interventionNames":46},"OLN324","EXPERIMENTAL",[47],"Drug: OLN324",{"label":49,"type":50,"description":30,"interventionNames":51},"Aflibercept","ACTIVE_COMPARATOR",[52],"Drug: Aflibercept",[54,58],{"type":55,"name":44,"description":56,"armGroupLabels":57,"otherNames":30},"DRUG","OLN324 by intravitreal injection at protocol-specified dosing intervals",[44],{"type":55,"name":49,"description":59,"armGroupLabels":60,"otherNames":30},"Aflibercept by intravitreal injection at protocol specified dosing intervals",[49],[62],{"name":63,"role":64,"phone":65,"phoneExt":30,"email":66},"Varun Malhotra, MD","CONTACT","737-330-1517","ollinclinops@ollin.bio",{"type":68,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100657670","phase-3-phase-3-study-of-intravitreal-oln324-in-adults-with-diabetic-macular-edema-dme-oln324-cp-03-100657670",false,"NCT07842016","Phase 3 Study of Intravitreal OLN324 in Adults With Diabetic Macular Edema (DME) (OLN324-CP-03)","A Phase 3, Randomized, Double-masked, Multicenter, Active Comparator-controlled Trial to Investigate the Efficacy and Safety of Intravitreal OLN324 in Adult Participants With Diabetic Macular Edema (DME) (GOBI)","GOBI","Inclusion Criteria:\n\n* Capable of giving signed informed consent\n* Be ≥18 years of age.\n* Have type 1 or type 2 diabetes mellitus\n* Have a decrease in vision in the study eye due to diabetic macular edema (DME), with best corrected visual acuity of 78 to 25 letters\n* Have macular edema on OCT with a CST of ≥ 325 µm\n* Participants may be either treatment-naïve or previously-treated for DME in their study eye. The number of previously-treated participants is limited.\n* Additional inclusion criteria apply\n\nExclusion Criteria:\n\n* Be pregnant or breastfeeding\n* History of cataract surgery in the study eye within 90 days of Screening\n* Has uncontrolled glaucoma in the study eye\n* Has uncontrolled hypertension\n* Has had a stroke or myocardial infarction within 180 days\n* If in the cohort of previously treated for DME participants, prior treatment with intravitreal bevacizumab, aflibercept, faricimab, ranibizumab, conbercept, or other approved anti-VEGF or Anti-VEGF\u002FAnti-Ang-2 therapies within 90 days of randomization.\n* Additional exclusion criteria apply","ALL","18 Years",{"count":80,"type":81},450,"ESTIMATED","INTERVENTIONAL",[84],"PHASE3","This is a Phase 3 study of an investigational drug called OLN324, which is being developed by Ollin Biosciences as a treatment for patients with diabetic macular edema (DME).",[87],"Diabetic Macular Edema (DME)",[89,90,91,92,44,93,5],"DME","Diabetic Macular Edema","Diabetic Retinopathy","Diabetic Eye Disease","Ollin","NOT_YET_RECRUITING","2026-09-21",{"date":97,"type":98},"2026-09-25","ACTUAL",{"date":100,"type":81},"2026-10-15",{"date":102,"type":81},"2029-12-15",{"name":5,"class":6}]