[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100263285":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":48,"collaborators":22,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":22,"enrollmentInfo":60,"targetDuration":22,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":36,"whyStopped":22,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"American University of Beirut Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intravitreal","ACTIVE_COMPARATOR","Intravitreal injection of 1.5mg\u002F0.03ml adalimumab given at zero, 2 weeks, and then every 4 weeks.",[13],"Drug: Adalimumab",{"label":15,"type":10,"description":16,"interventionNames":17},"Systemic","Subcutaneous injection of 40 mg adalimumab (Humira) given every 2 weeks.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":22},"DRUG","Adalimumab",null,[9,15],[25],{"name":26,"affiliation":5,"role":27},"Rola N Hamam, MD","PRINCIPAL_INVESTIGATOR",[29],{"name":26,"role":30,"phone":31,"phoneExt":32,"email":33},"CONTACT","+961-1-350000","5550","rh46@aub.edu.lb",[35],{"facility":5,"status":36,"city":37,"state":22,"zip":22,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Beirut","Lebanon","LB",{"type":41,"coordinates":42},"Point",[43,44],35.50157,33.89332,{"lat":44,"lon":43},[47],{"name":26,"role":30,"phone":31,"phoneExt":32,"email":33},{"type":49,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100263285","phase-2-intravitreal-adalimumab-versus-subcutaneous-adalimumab-in-non-infectious-uveitis-100263285",false,"NCT02706704","Intravitreal Adalimumab Versus Subcutaneous Adalimumab in Non-infectious Uveitis","Efficacy of Intravitreal Adalimumab Compared to Subcutaneous Adalimumab in Patients With Non-infectious Uveitis","IVAS","Inclusion Criteria:\n\n* Subject is ≥ 18 years of age.\n* Subject is diagnosed with non-infectious intermediate-, posterior-, or pan-uveitis.\n* Subject must have active disease at baseline as defined by the presence of at least 1 of the following parameters in at least one eye despite at least 2 weeks of prednisone ≥ 10 mg\u002Fday (or oral corticosteroid equivalent):\n\n  * Active, inflammatory, chorioretinal and\u002For inflammatory retinal vascular lesion\n  * ≥ 1+ anterior chamber cells (Standardization of Uveitis Nomenclature \\[SUN\\] criteria)\n  * ≥ 1+ vitreous haze (National Eye Institute \\[NEI\\]\u002FSUN criteria)\n* Subject with documented prior adequate response to oral corticosteroids (equivalent of oral prednisone up to 1 mg\u002Fkg\u002Fday).\n* If subject is on prednisone \\>=10 mg (or corticosteroid equivalent) at baseline, the dose has not been increased or decreased in the past 14 days.\n* No increase in the immune modulatory therapy in the past three months\n* Negative PPD test.\n* Positive PPD test on anti Tb medications.\n\nExclusion Criteria:\n\n* Subject with isolated anterior uveitis.\n* Subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus, lyme disease, toxoplasmosis and herpes simplex virus (HSV).\n* Subject with serpiginous choroidopathy.\n* Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial.\n* Subject with corneal or lens opacities that preclude the evaluation of the vitreous haze.\n* Subject with uncontrolled high intraocular pressure of ≥ 25 mmHg on maximal therapy.\n* Subject with intermediate uveitis and symptoms and\u002For MRI findings suggestive of a demyelinating disease such as multiple sclerosis. All subjects with intermediate uveitis must have had a prior brain MRI at time of or after diagnosis of intermediate uveitis.\n* Subject has received glucocorticosteroids implant (Retisert®), or Ozurdex within 6 months prior to baseline visit.\n* Subject has received intraocular or periocular corticosteroids or intravitreal methotrexate within 90 days prior to Baseline visit.\n* Subject with proliferative or severe non-proliferative diabetic retinopathy.\n* Subject with neovascular\u002Fwet age-related macular degeneration\n* Subject with abnormality of vitreo-retinal interface (i.e., vitreomacular traction, epiretinal membranes, etc.) with the potential for macular structural damage independent of the inflammatory process.\n* Subject with a systemic inflammatory disease and requires additional therapy with a systemic immunosuppressive agent at the time of study entry.\n* Subjects with history of active or latent Mycobacterium tuberculosis documented by Purified Protein Derivative (PPD) and chest X-ray and not anti tuberculosis (TB) treatment.","ALL","18 Years",{"count":61,"type":62},32,"ESTIMATED","INTERVENTIONAL",[65],"PHASE2","The objective of this study is to compare and evaluate the efficacy of subcutaneous (40mg) adalimumab biweekly injections to intravitreal adalimumab (1.5 mg\u002F 0.03 mL) administration, given at zero, 2 weeks then every four weeks, in subjects with active non-infectious intermediate-, posterior-, or pan-uveitis.",[68,69],"Uveitis","Non-Infectious Uveitis",[71,72],"Intravitreal Adalimumab","Subcutaneous Adalimumab","2025-02-24",{"date":75,"type":76},"2025-02-26","ACTUAL",{"date":78,"type":76},"2016-02",{"date":80,"type":62},"2026-02",{"name":5,"class":6},1]