[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655536":3},{"organization":4,"outcomesModule":7,"designInfo":20,"detailedDescription":31,"studyPopulation":16,"armGroups":32,"interventions":51,"overallOfficials":16,"centralContacts":68,"locations":74,"responsibleParty":91,"collaborators":16,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":95,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":16,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":77,"whyStopped":16,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"BioAge Labs, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Best Corrected Visual Acuity (BCVA)","Change from Baseline in BCVA as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) in the Study Eye","Week 12",[14,18],{"measure":15,"description":16,"timeFrame":17},"Incidence of serious adverse events (SAEs)",null,"Up to Week 16",{"measure":19,"description":16,"timeFrame":17},"Incidence of treatment-emergent adverse events (TEAEs)",{"allocation":21,"interventionModel":22,"interventionModelDescription":16,"primaryPurpose":23,"observationalModel":16,"timePerspective":16,"maskingInfo":24},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":25,"maskingDescription":26,"whoMasked":27},"TRIPLE","The injecting clinician is unmasked",[28,29,30],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","The purpose of this study is to assess the efficacy and safety of oral once a day (QD) dosing of BGE-102 alone or BGE-102 in combination with an anti-VEGF drug compared to anti-VEGF alone in participants with CI-DME on ocular parameters over 12 weeks of treatment.\n\nStudy details include:\n\n* The study duration will be approximately 20 weeks (5 months) including the following study periods: screening (up to 4 weeks), treatment (12 weeks), and post treatment follow-up (4 weeks).\n* The visit frequency will be every 2 weeks for the first 4 weeks of the treatment period and every 4 weeks thereafter up to Week 16.\n* The treatment duration will be up to 12 weeks. BGE-102 will be given active, once daily capsules, or placebo, once daily capsules, in combination with anti-VEGF every four weeks intravitreal injection or sham injection for the entire 12-week treatment period.",[33,40,45],{"label":34,"type":35,"description":36,"interventionNames":37},"Arm A: BGE-102 Monotherapy","EXPERIMENTAL","BGE-102 Capsules dosed once daily in combination with Sham intravitreal injection delivered every 4 weeks",[38,39],"Drug: Oral BGE-102","Other: Sham",{"label":41,"type":35,"description":42,"interventionNames":43},"Arm B: BGE-102 and anti-VEGF Combination Therapy","BGE-102 Capsules dosed once daily in combination with anti-VEGF intravitreal injection delivered every 4 weeks",[38,44],"Drug: Anti-VEGF",{"label":46,"type":47,"description":48,"interventionNames":49},"Arm C: anti-VEGF Monotherapy","ACTIVE_COMPARATOR","Placebo Capsules dosed once daily in combination with anti-VEGF intravitreal injection delivered every 4 weeks",[50,44],"Drug: Oral Placebo Matching BGE-102",[52,57,60,64],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":16},"DRUG","Oral BGE-102","Capsules",[34,41],{"type":53,"name":58,"description":55,"armGroupLabels":59,"otherNames":16},"Oral Placebo Matching BGE-102",[46],{"type":53,"name":61,"description":62,"armGroupLabels":63,"otherNames":16},"Anti-VEGF","intravitreal injection",[41,46],{"type":65,"name":66,"description":62,"armGroupLabels":67,"otherNames":16},"OTHER","Sham",[34],[69],{"name":70,"role":71,"phone":72,"phoneExt":16,"email":73},"Central Recruiting","CONTACT","866-331-7781","bge102-004_inquiry@bioagelabs.com",[75],{"facility":76,"status":77,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Site 106","RECRUITING","McAllen","Texas","78503","United States","US",{"type":84,"coordinates":85},"Point",[86,87],-98.23001,26.20341,{"lat":87,"lon":86},[90],{"name":70,"role":71,"phone":72,"phoneExt":16,"email":73},{"type":92,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100655536","phase-2-a-randomized-phase-2-study-of-oral-bge-102-in-participants-with-center-involved-diabetic-macular-edema-100655536",false,"NCT07812090","A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema","A Randomized, Double-Masked, Multicenter Phase 2 Study Evaluating the Efficacy, Safety, and Tolerability of Oral BGE-102 as Mono- and Combination Therapy in Participants With Center-Involved Diabetic Macular Edema","QUELL-DME","Inclusion Criteria:\n\n* Adults 18-75 years of age\n* Type 1 or Type 2 Diabetes diagnosis\n* Diabetic Macular Edema (DME) affecting the center of vision\n* Study Eye may be treatment naïve (never received treatment) or previously treated and if previously treated, meets washout requirements\n* Acceptable Vision as measured by an eye chart\n* Visual Acuity and retinal thickness as measured by an eye scan, results meeting eligibility criteria\n* Willing to use birth control, if applicable\n\nExclusion Criteria:\n\n* Significant ocular disease, condition, or prior ocular treatment and\u002F or procedure that could affect vision, study assessments, or participant safety, including failure to meet required treatment washout periods\n* Macular edema in the study eye due to causes other than DME, such as retinal vein occlusion, uveitis, neovascular age-related macular degeneration\n* Significant macular ischemia in the study eye that would limit visual improvement as assessed by the Investigator and confirmed by the Reading Center\n* Uncontrolled diabetes\n* Uncontrolled blood pressure\n* Medically unstable cardiac conditions and\u002For medically important ECG abnormalities.\n* Relevant medical or psychiatric condition(s) that put the participant at risk or will make implementation of the protocol or interpretation of the study difficult.\n* Women who are pregnant or nursing","ALL","18 Years","75 Years",{"count":105,"type":106},180,"ESTIMATED","INTERVENTIONAL",[109],"PHASE2","The purpose of this study is to learn about the effects of BGE-102 on change in vision in participants with center-involved diabetic macular edema (CI-DME). BGE-102 decreases inflammation which may improve vision or slow the progression of vison loss in those with CI-DME. Participants will be randomized to one of 3 arms and receive either BGE-102 in combination with an anti-vascular endothelial growth factor (anti-VEGF) drug, BGE-102 in combination with sham injection, or BGE-102 placebo in combination with an anti-VEGF drug. This study will also evaluate safety and tolerability of BGE-102.",[112],"Diabetic Macular Edema (DME)",[114,115,116,117,118,119],"Diabetic Macular Edema","Diabetic Retinopathy","BGE-102","BioAge","NLRP3","Center-Involved","2026-09-04",{"date":122,"type":123},"2026-09-10","ACTUAL",{"date":125,"type":123},"2026-08-21",{"date":127,"type":106},"2027-12",{"name":5,"class":6},1]