[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Regenerative Ocular Immunobiologics LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":57},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"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":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27],"oGVHD","Ocular Graft Versus Host Disease",[26,29,27],"Ocular Graft-Versus-Host Disease","NOT_YET_RECRUITING","2026-08-20",{"date":33,"type":34},"2026-08-21","ACTUAL",{"date":36,"type":20},"2026-08-19",{"date":38,"type":20},"2027-06-30",{"name":40,"class":41},"Regenerative Ocular Immunobiologics LLC","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":4,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":49,"phases":4,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":56,"locationsCount":4},"100609135","expanded-access-for-d-mapps-ophthalmic-solution-in-the-treatment-of-chronic-ocular-graft-versus-host-disease-ogvhd-100609135","NCT07210619","Expanded Access for d-MAPPS™ Ophthalmic Solution, in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD)","Inclusion Criteria:\n\n* Age ≥18 years.\n* Willing and able to provide written informed consent.\n* Willing and able to comply with study assessments for the full duration of the study.\n* Patients may be using bilateral scleral lenses and\u002For bilateral punctal plugs at the time of accrual.\n* Minimum Oxford Schema grade of ≥1 in at least one eye.\n* OSDI score of ≥22.\n* UNC DEMS score of ≥3.\n* In good stable overall health\n* Note: If the patient has no exclusion criteria, investigator can combine the Pre-screen and Baseline visit\n\nExclusion Criteria:\n\n* History of Rheumatoid Arthritis, Lupus, Scleroderma. (Exception may be made at the discretion of the Principal Investigator if it is determined that the patient would benefit from d-MAPPS ophthalmic solution).\n* Ocular or periocular malignancy.\n* Significant change, as judged by the principal investigator, in systemic immunosuppressive regimen within 2 weeks of study entry.\n* Any history of topical tacrolimus use (Exception may be made at the discretion of the Principal Investigator if it is determined that the patient would benefit from d-MAPPS ophthalmic solution).\n* Any change in dosage of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the last month.\n* Any change in frequency of preserved anti-glaucoma medications within 2 weeks of study entry.\n* Current use of topical steroids more than twice a day.\n* Corneal epithelial defect \\>1mm2.\n* Any history of herpetic keratitis. (Exception may be made at the discretion of the Principal Investigator if it is determined that the patient would benefit from d-MAPPS ophthalmic solution).\n* Participation in another simultaneous medical research study.\n* Signs of current infection, including fever and current treatment with antibiotics.\n* All vaccinations including COVID are prohibited during this study.\n* Intra-ocular surgery or ocular laser surgery within 3 months. (Exception may be made at the discretion of the Principal Investigator if it is determined that the patient would benefit from d-MAPPS ophthalmic solution following surgery.)\n* Women who are pregnant, breastfeeding, or plan to become pregnant while participating in the study. If of child-bearing potential, unwillingness to use effective birth control while participating in the study.)\n* Any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study.","EXPANDED_ACCESS","Regenerative Ocular Immunobiologics, LLC Fast Track Expanded Access This Expanded Access Policy describes the conditions under which ROI may make its investigational product - Sterile Processed Derived Multiple Allogeneic Proteins Paracrine Signaling (d-MAPPS™ Ophthalmic Solution) - available to patients outside of a clinical trial, in accordance with U.S. FDA regulations, including section 561A of the Federal Food, Drug, and Cosmetic Act (FDCA).",[26],"AVAILABLE","2025-10-08",{"date":55,"type":34},"2025-10-10",{"name":40,"class":41},""]