[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ogvhd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ogvhd":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,68],{"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":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":42},"100435170","2177gccciding-tx-targets-and-biomarkers-for-ocular-surface-disease-in-pt-w-ogvhd-100435170","NCT04946721","2177GCCC:ID'Ing tx Targets and Biomarkers for Ocular Surface Disease in Pt w\u002F oGVHD","2177GCCC: Identifying Novel Treatment Targets and Biomarkers for Ocular Surface Disease in Patients With Ocular Graft vs Host Disease (oGVHD) a Biobank Study","Inclusion Criteria:\n\n* Adult patients (≥ 18 years of age) who visit the Eye clinic either in the UMGCCC within the UMD Hospital or the UMD Faculty Physicians Ophthalmology Practice at the UMD Professional Building or satellite locations for initial visits or established visits.\n* The patient must be able to understand and sign and date the informed consent form approved by the IRB.\n\nExclusion Criteria:\n\n* Vulnerable populations: neonates, children, prisoners, institutionalized individuals.\n* Inability or refusal to provide informed consent.\n* History of ocular surgery (except refractive surgery or cataract surgery)",true,{"count":52,"type":20},150,"OBSERVATIONAL","Evaluate and study the immunologic changes to the ocular surface in cancer patients.",[56,26],"Dry Eye Disease","RECRUITING","2026-01-30",{"date":60,"type":34},"2026-02-03",{"date":62,"type":34},"2022-04-27",{"date":64,"type":20},"2027-12-31",{"name":66,"class":67},"University of Maryland, Baltimore","OTHER",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":4,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":81,"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":80,"type":34},"2025-10-10",{"name":40,"class":41}]