[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652635":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":57,"collaborators":11,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":11,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":11,"enrollmentInfo":68,"targetDuration":11,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":80,"whyStopped":11,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Regenerative Ocular Immunobiologics LLC","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Vehicle Controlled","PLACEBO_COMPARATOR",null,[13],"Biological: Matching vehicle control",{"label":15,"type":16,"description":11,"interventionNames":17},"Active Study Drug","EXPERIMENTAL",[18],"Biological: d-MAPPS™ Ophthalmic Solution",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"BIOLOGICAL","d-MAPPS™ Ophthalmic Solution","Sterile, preservative-free ophthalmic solution administered as two drops into each eye four times daily for 90 consecutive days.",[15],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Matching vehicle control","Matching vehicle control supplied in identical masked containers and administered as two drops into each eye four times daily for 90 consecutive days.",[9],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Marissa Harrell, PhD","CONTACT","727-748-0420","info@roiglobalsolutions.org",[36],{"facility":37,"status":11,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Regenerative Ocular Immunobiologics, LLC.","Palm Harbor","Florida","34684","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-82.76371,28.07807,{"lat":47,"lon":46},[50,53],{"name":51,"role":32,"phone":33,"phoneExt":11,"email":52},"Marissa Harrell, CEO, PhD","Marissa@roiglobalsolutions.org",{"name":54,"role":32,"phone":55,"phoneExt":11,"email":56},"Craig Hull, COO","727-460-4116","Craig@roiglobalsolutions.org",{"type":58,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100652635","phase-3-study-of-d-mapps-ophthalmic-solution-in-adults-with-chronic-ocular-graft-versus-host-disease-ogvhd-100652635",false,"NCT07776210","Study of d-MAPPS™ Ophthalmic Solution in Adults With Chronic Ocular Graft-Versus-Host Disease (oGVHD)","A Randomized, Double-Masked, Vehicle-Controlled, Adequate and Well-Controlled Pivotal Study With Co-Primary Endpoints to Evaluate the Safety and Efficacy of d-MAPPS™ Ophthalmic Solution in Subjects With Chronic Ocular Graft-Versus-Host Disease (oGVHD)","Inclusion Criteria:\n\n* Age 18 years or older.\n* Documented chronic ocular graft-versus-host disease (oGVHD) following allogeneic hematopoietic stem cell transplantation.\n* Investigator determines the participant is medically stable and appropriate for study participation.\n* Ocular Surface Disease Index (OSDI) Total Score of at least 33 at Baseline.\n* UNC Dry Eye Management Scale Visual Analog Scale (UNC DEMS VAS) score of at least 3 at Baseline.\n* Modified Oxford Corneal Staining Score of at least 1 in at least one eye.\n* Snellen Corrected Distance Visual Acuity sufficient to complete protocol-defined assessments.\n* Written informed consent obtained before study procedures.\n* Willing and able to comply with study visits, study treatment, and protocol requirements.\n* Background therapies stable for at least 30 days before Baseline.\n\nExclusion Criteria:\n\n* Acute ocular graft-versus-host disease or ocular disease that may interfere with efficacy assessment.\n* Active ocular or periocular infection, ocular malignancy, or active herpetic keratitis.\n* Intraocular surgery, refractive surgery, or ocular laser procedure within 6 weeks before Baseline or planned during the study.\n* Change in systemic immunosuppressive therapy, topical glaucoma therapy, or oral tetracycline therapy within 30 days before Baseline.\n* Initiation within 30 days before Baseline or during the trial of topical cyclosporine, lifitegrast, tacrolimus, autologous serum eye drops, platelet-rich plasma eye drops, amniotic membrane products, or another prescription therapy intended to treat ocular surface disease.\n* Participation in another investigational study within 30 days before Screening or concurrent enrollment.\n* Pregnancy or breastfeeding.","ALL","18 Years",{"count":69,"type":70},30,"ESTIMATED","INTERVENTIONAL",[73],"PHASE3","This is a Phase III, multicenter, randomized, double-masked, vehicle-controlled, parallel-group clinical trial designed to evaluate the efficacy, safety, and tolerability of d-MAPPS™ Ophthalmic Solution in adult subjects with chronic ocular graft-versus-host disease (oGVHD). Eligible subjects will receive masked study treatment for 90 days, with the primary efficacy assessment performed at the Day 90 study visit.",[76,77],"oGVHD","Ocular Graft Versus Host Disease",[76,79,77],"Ocular Graft-Versus-Host Disease","NOT_YET_RECRUITING","2026-08-20",{"date":83,"type":84},"2026-08-21","ACTUAL",{"date":86,"type":70},"2026-08-19",{"date":88,"type":70},"2027-06-30",{"name":5,"class":6},1]