[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587291":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":34,"responsibleParty":51,"collaborators":32,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":32,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":32,"enrollmentInfo":63,"targetDuration":32,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":75,"overallStatus":80,"whyStopped":32,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Massachusetts Eye and Ear Infirmary","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Adalimumab (Humira)","EXPERIMENTAL","This arm will receive the study intervention.",[13],"Drug: Adalimumab Injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Adalimumab Injection","10% (4.0mg\u002F0.04ml) dissolved in sterile saline to be injected once during the time of the Boston Keratoprosthesis (Kpro) Surgery.",[9],[21],"Humira",[23],{"name":24,"affiliation":25,"role":26},"Thomas Dohlman, MD","Massachusetts Eye and Ear","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Michael Cheung, MSc, CCRP","CONTACT","617-573-6060",null,"MCHEUNG0@MEEI.HARVARD.EDU",[35],{"facility":25,"status":32,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Boston","Massachusetts","02114","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-71.05977,42.35843,{"lat":45,"lon":44},[48,50],{"name":29,"role":30,"phone":49,"phoneExt":32,"email":33},"6175736060",{"name":24,"role":26,"phone":32,"phoneExt":32,"email":32},{"type":26,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Thomas H. Dohlman, MD","Principal Investigator","100587291","phase-1-subconjunctival-humira-for-boston-keratoprosthesis-100587291",false,"NCT06926478","Subconjunctival Humira for Boston Keratoprosthesis","Clinical Trial to Evaluate Short-term Safety of Subconjunctival Adalimumab in Combination With Type 1 Boston Keratoprosthesis Implantation","Inclusion Criteria:\n\n* Age 18 years or older\n* Individuals eligible for keratoprosthesis surgery, as determined by standard-of-care eligibility criteria\n* Patients with poor prognosis for corneal transplantation, severe corneal opacity and\u002For vascularization\n* Patients with vision worse than 20\u002F200 in the eligible eye, and contralateral eye with vision less than 20\u002F40\n* Patients with intact nasal light projection\n* Willing and able to comply with study plan for the full duration of the study\n* Willing and able to sign a written informed consent\n\nExclusion Criteria:\n\n* Active tuberculosis or untreated latent tuberculosis (e.g., positive interferon-# release assay \\[IGRA\\] test, such as Quantiferon-gold)\n* Untreated active hepatitis B or C infection.\n* Ocular or periocular malignancy and\u002For infection\n* Inability to wear contact lens\n* Pregnancy (positive pregnancy test) or lactating\n* Participation in another interventional study at the time of screening\n* Any of the following baseline lab values\n\n  1. White blood count \\\u003C3500 cells per microliter\n  2. Platelets \\\u003C100,000 per microliter\n  3. Hematocrit \\\u003C30%\n  4. AST or ALT \\>1.5X upper limit normal value\n* Multiple sclerosis or other demyelinating disease\n* Severe uncontrolled infection\n* Moderate to severe heart failure (NYHA class III\u002FIV)\n* Active malignancy\n* History of adalimumab intolerance\n* Pregnancy or lactation\n* Medical problems or drug or alcohol dependence problems sufficient to prevent adherence to treatment and study procedures.\n* As judged by the investigator any patients that are questionable for their suitability in the study","ALL","18 Years",{"count":64,"type":65},8,"ESTIMATED","INTERVENTIONAL",[68],"PHASE1","This trial is studying the safety and tolerability of receiving an injection of adalimumab (Humira) during the Boston Keratoprosthesis (KPro) surgery.",[71,72,73,74],"Penetrating Keratoplasty","Multiple Graft Failure","Ocular Cicatricial Pemphigoid","Stevens-Johnson Syndrome",[76,77,78,79],"Kpro","Boston Kpro","Keratoprosthesis","Type-1 Boston Kpro","NOT_YET_RECRUITING","2026-03-23",{"date":83,"type":84},"2026-03-27","ACTUAL",{"date":86,"type":65},"2026-06-01",{"date":88,"type":65},"2028-06-01",{"name":5,"class":6},1]