[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627842":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":35,"responsibleParty":209,"collaborators":25,"id":211,"slug":212,"hasResults":213,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":25,"eligibilityCriteria":217,"healthyVolunteers":213,"sex":218,"minAge":219,"maxAge":220,"enrollmentInfo":221,"targetDuration":25,"studyType":224,"phases":225,"briefSummary":227,"conditions":228,"keywords":230,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":245},{"fullName":5,"class":6},"Dompé Farmaceutici S.p.A","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cenegermin","EXPERIMENTAL","Participants will be administered with cenegermin spray in each nostril.",[13],"Drug: Cenegermin",{"label":15,"type":16,"description":17,"interventionNames":18},"Vehicle","PLACEBO_COMPARATOR","Participants will be administered with vehicle spray in each nostril.",[19],"Other: Vehicle",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Cenegermin is administered intranasally.",[9],null,{"type":27,"name":15,"description":28,"armGroupLabels":29,"otherNames":25},"OTHER","Vehicle spray is administered intranasally.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":25},"Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)","CONTACT","+39 02 583 831",[36,50,57,66,76,86,95,105,111,121,131,141,151,160,170,179,189,199],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":25},"Neuro Eye Orbit Institute","RECRUITING","Los Angeles","California","90048","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-118.24368,34.05223,{"lat":48,"lon":47},{"facility":51,"status":52,"city":39,"state":40,"zip":53,"country":42,"countryCode":43,"cosmosGeoPoint":54,"geoPoint":56,"contacts":25},"David Geffen School of Medicine at UCLA - Ophthalmology","NOT_YET_RECRUITING","90095",{"type":45,"coordinates":55},[47,48],{"lat":48,"lon":47},{"facility":58,"status":52,"city":59,"state":40,"zip":60,"country":42,"countryCode":43,"cosmosGeoPoint":61,"geoPoint":65,"contacts":25},"California Orbital Consultants","Newport Beach","92660",{"type":45,"coordinates":62},[63,64],-117.92895,33.61891,{"lat":64,"lon":63},{"facility":67,"status":52,"city":68,"state":69,"zip":70,"country":42,"countryCode":43,"cosmosGeoPoint":71,"geoPoint":75,"contacts":25},"University of Colorado Anschutz Medical Campus","Aurora","Colorado","80045",{"type":45,"coordinates":72},[73,74],-104.83192,39.72943,{"lat":74,"lon":73},{"facility":77,"status":52,"city":78,"state":79,"zip":80,"country":42,"countryCode":43,"cosmosGeoPoint":81,"geoPoint":85,"contacts":25},"Bascom Palmer Eye Institute, University of Miami School of Medicine","Miami","Florida","33136",{"type":45,"coordinates":82},[83,84],-80.19366,25.77427,{"lat":84,"lon":83},{"facility":87,"status":52,"city":88,"state":79,"zip":89,"country":42,"countryCode":43,"cosmosGeoPoint":90,"geoPoint":94,"contacts":25},"Sarasota Retina Institute - Research","Sarasota","34239",{"type":45,"coordinates":91},[92,93],-82.53065,27.33643,{"lat":93,"lon":92},{"facility":96,"status":52,"city":97,"state":98,"zip":99,"country":42,"countryCode":43,"cosmosGeoPoint":100,"geoPoint":104,"contacts":25},"Northwestern University - Ophthalmology","Chicago","Illinois","60611",{"type":45,"coordinates":101},[102,103],-87.65005,41.85003,{"lat":103,"lon":102},{"facility":106,"status":52,"city":97,"state":98,"zip":107,"country":42,"countryCode":43,"cosmosGeoPoint":108,"geoPoint":110,"contacts":25},"University of Illinois at Chicago Eye and Ear Infirmary - Ophthalmology","60612",{"type":45,"coordinates":109},[102,103],{"lat":103,"lon":102},{"facility":112,"status":52,"city":113,"state":114,"zip":115,"country":42,"countryCode":43,"cosmosGeoPoint":116,"geoPoint":120,"contacts":25},"Univ. Of Kentucky Clinic Dept of Ophthalmology & Vision Science","Lexington","Kentucky","40508",{"type":45,"coordinates":117},[118,119],-84.47772,37.98869,{"lat":119,"lon":118},{"facility":122,"status":52,"city":123,"state":124,"zip":125,"country":42,"countryCode":43,"cosmosGeoPoint":126,"geoPoint":130,"contacts":25},"The Johns Hopkins Hospital (JHH)","Baltimore","Maryland","21287",{"type":45,"coordinates":127},[128,129],-76.61219,39.29038,{"lat":129,"lon":128},{"facility":132,"status":52,"city":133,"state":134,"zip":135,"country":42,"countryCode":43,"cosmosGeoPoint":136,"geoPoint":140,"contacts":25},"Tufts Medical Center - Neurology","Boston","Massachusetts","02116",{"type":45,"coordinates":137},[138,139],-71.05977,42.35843,{"lat":139,"lon":138},{"facility":142,"status":52,"city":143,"state":144,"zip":145,"country":42,"countryCode":43,"cosmosGeoPoint":146,"geoPoint":150,"contacts":25},"University of Michigan Health - Kellogg Eye Center","Ann Arbor","Michigan","48105",{"type":45,"coordinates":147},[148,149],-83.74088,42.27756,{"lat":149,"lon":148},{"facility":152,"status":52,"city":153,"state":144,"zip":154,"country":42,"countryCode":43,"cosmosGeoPoint":155,"geoPoint":159,"contacts":25},"Trinity Health Grand Rapids","Grand Rapids","49503",{"type":45,"coordinates":156},[157,158],-85.66809,42.96336,{"lat":158,"lon":157},{"facility":161,"status":52,"city":162,"state":163,"zip":164,"country":42,"countryCode":43,"cosmosGeoPoint":165,"geoPoint":169,"contacts":25},"University of Minnesota, Dept of Ophthalmology","Minneapolis","Minnesota","55455",{"type":45,"coordinates":166},[167,168],-93.26384,44.97997,{"lat":168,"lon":167},{"facility":171,"status":38,"city":172,"state":163,"zip":173,"country":42,"countryCode":43,"cosmosGeoPoint":174,"geoPoint":178,"contacts":25},"Mayo Clinic - Department of Ophthalmology","Rochester","55905",{"type":45,"coordinates":175},[176,177],-92.4699,44.02163,{"lat":177,"lon":176},{"facility":180,"status":52,"city":181,"state":182,"zip":183,"country":42,"countryCode":43,"cosmosGeoPoint":184,"geoPoint":188,"contacts":25},"University of Pennsylvania - Ophthalmology","Philadelphia","Pennsylvania","19104",{"type":45,"coordinates":185},[186,187],-75.16362,39.95238,{"lat":187,"lon":186},{"facility":190,"status":38,"city":191,"state":192,"zip":193,"country":42,"countryCode":43,"cosmosGeoPoint":194,"geoPoint":198,"contacts":25},"Retina Consultants of South Carolina, Charleston Neuroscience Institute- West Ashley (RCA)","Charleston","South Carolina","29414",{"type":45,"coordinates":195},[196,197],-79.93275,32.77632,{"lat":197,"lon":196},{"facility":200,"status":52,"city":201,"state":202,"zip":203,"country":42,"countryCode":43,"cosmosGeoPoint":204,"geoPoint":208,"contacts":25},"Neuro Eye Clinical Trials","Houston","Texas","77074",{"type":45,"coordinates":205},[206,207],-95.36327,29.76328,{"lat":207,"lon":206},{"type":210,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100627842","phase-3-efficacy-and-safety-of-intranasal-cenegermin-in-adult-participants-with-non-arteritic-anterior-ischemic-optic-neuropathy-naion-100627842",false,"NCT07453888","Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)","Randomized, Multicenter, Vehicle-Controlled, Double-Masked Phase 3 Study to Evaluate the Efficacy and Safety of Intranasal Cenegermin (Recombinant Human Nerve Growth Factor [rhNGF]) in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)","Key Inclusion Criteria:\n\n1. A clinical diagnosis of unilateral NAION in the study eye with symptom onset within 14 days prior to the planned date for first dose administration.\n2. A BCVA score in the study eye of ≥ 15 letters and ≤ 65 letters measured using the ETDRS chart.\n3. Sufficiently clear ocular media and adequate pupil dilation to enable assessment of the optic nerve and retina in both eyes.\n\nKey Exclusion Criteria:\n\n1. Bilateral NAION or sequential NAION with fellow eye involvement within 6 weeks of study eye involvement.\n2. Clinical evidence of temporal arteritis (giant cell arteritis) signs or symptoms.\n3. Abnormal laboratory findings suggestive of temporal arteritis (giant cell arteritis), in the absence of a known acute cause\n4. Pain with eye movement\n5. Intraocular pressure (IOP) greater than 25 mmHg in the study eye or history of glaucoma in the study eye.\n6. Intermediate age-related macular degeneration (AMD) with subfoveal drusen, exudative AMD, or geographic atrophy in the study eye.\n\nNote: Additional inclusion\u002Fexclusion criteria apply, as defined in the protocol.","ALL","50 Years","80 Years",{"count":222,"type":223},272,"ESTIMATED","INTERVENTIONAL",[226],"PHASE3","This is a phase 3, randomized, multicenter, vehicle-controlled, double-masked study to evaluate the efficacy and safety of intranasal cenegermin compared with vehicle control in adult participants with NAION. Approximately 272 participants who meet all eligibility criteria will be randomly assigned in a 1:1 ratio to receive either cenegermin treatment (Group 1) or the vehicle control (Group 2).",[229],"Non-Arteritic Anterior Ischemic Optic Neuropathy",[231,229,232,233,234,235],"Acute optic neuropathy","NAION","cenegermin","Optic neuropathy","Intranasal","2026-06-18",{"date":238,"type":239},"2026-06-22","ACTUAL",{"date":241,"type":223},"2026-06-30",{"date":243,"type":223},"2027-09",{"name":5,"class":6},18]