[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627842":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":20,"studyPopulation":20,"armGroups":42,"interventions":55,"overallOfficials":20,"centralContacts":64,"locations":69,"responsibleParty":243,"collaborators":20,"id":245,"slug":20,"hasResults":246,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":20,"eligibilityCriteria":250,"healthyVolunteers":246,"sex":251,"minAge":252,"maxAge":253,"enrollmentInfo":254,"targetDuration":20,"studyType":257,"phases":258,"briefSummary":260,"conditions":261,"keywords":263,"overallStatus":72,"whyStopped":20,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":278},{"fullName":5,"class":6},"Dompé Farmaceutici S.p.A","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Achievement of ≥ 15 letter increase in Best Corrected Visual Acuity (BCVA), assessed in each individual participant, measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart","Improvement in visual acuity defined as a \\>=15 letter increase in BCVA using ETDRS chart.","Baseline to Week 24",[14,18,21,24,27],{"measure":15,"description":16,"timeFrame":17},"Change from baseline in visual field mean sensitivity in decibels","Change from baseline in visual field mean sensitivity in decibels will be analyzed","Baseline through Week 24",{"measure":19,"description":20,"timeFrame":17},"Change from baseline in BCVA as measured by the ETDRS chart",null,{"measure":22,"description":23,"timeFrame":17},"Change from baseline in visual field mean sensitivity, in a prespecified region consisting of at least 5 separate loci on visual field testing","Change from baseline in mean sensitivity at week 24 in loci prespecified at baseline will be analyzed.",{"measure":25,"description":26,"timeFrame":17},"Change from baseline in ganglion cell layer-inner plexiform layer (GCL-IPL) thickness (micrometer [μm]) on optical coherence tomography (OCT).","Change from baseline in GCL-IPL thickness on optical coherence tomography will be analyzed.",{"measure":28,"description":29,"timeFrame":30},"Incidence of ocular and non-ocular adverse events","Number of participants with ocular and non-ocular adverse events will be assessed.","Through Week 24",{"allocation":32,"interventionModel":33,"interventionModelDescription":20,"primaryPurpose":34,"observationalModel":20,"timePerspective":20,"maskingInfo":35},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":36,"maskingDescription":37,"whoMasked":38},"TRIPLE","The sponsor is also masked to the study treatment.",[39,40,41],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[43,49],{"label":44,"type":45,"description":46,"interventionNames":47},"Cenegermin","EXPERIMENTAL","Participants will be administered with cenegermin spray in each nostril.",[48],"Drug: Cenegermin",{"label":50,"type":51,"description":52,"interventionNames":53},"Vehicle","PLACEBO_COMPARATOR","Participants will be administered with vehicle spray in each nostril.",[54],"Other: Vehicle",[56,60],{"type":57,"name":44,"description":58,"armGroupLabels":59,"otherNames":20},"DRUG","Cenegermin is administered intranasally.",[44],{"type":61,"name":50,"description":62,"armGroupLabels":63,"otherNames":20},"OTHER","Vehicle spray is administered intranasally.",[50],[65],{"name":66,"role":67,"phone":68,"phoneExt":20,"email":20},"Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)","CONTACT","+39 02 583 831",[70,84,91,100,110,120,129,139,145,155,165,175,185,194,204,213,223,233],{"facility":71,"status":72,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":20},"Neuro Eye Orbit Institute","RECRUITING","Los Angeles","California","90048","United States","US",{"type":79,"coordinates":80},"Point",[81,82],-118.24368,34.05223,{"lat":82,"lon":81},{"facility":85,"status":86,"city":73,"state":74,"zip":87,"country":76,"countryCode":77,"cosmosGeoPoint":88,"geoPoint":90,"contacts":20},"David Geffen School of Medicine at UCLA - Ophthalmology","NOT_YET_RECRUITING","90095",{"type":79,"coordinates":89},[81,82],{"lat":82,"lon":81},{"facility":92,"status":86,"city":93,"state":74,"zip":94,"country":76,"countryCode":77,"cosmosGeoPoint":95,"geoPoint":99,"contacts":20},"California Orbital Consultants","Newport Beach","92660",{"type":79,"coordinates":96},[97,98],-117.92895,33.61891,{"lat":98,"lon":97},{"facility":101,"status":86,"city":102,"state":103,"zip":104,"country":76,"countryCode":77,"cosmosGeoPoint":105,"geoPoint":109,"contacts":20},"University of Colorado Anschutz Medical Campus","Aurora","Colorado","80045",{"type":79,"coordinates":106},[107,108],-104.83192,39.72943,{"lat":108,"lon":107},{"facility":111,"status":86,"city":112,"state":113,"zip":114,"country":76,"countryCode":77,"cosmosGeoPoint":115,"geoPoint":119,"contacts":20},"Bascom Palmer Eye Institute, University of Miami School of Medicine","Miami","Florida","33136",{"type":79,"coordinates":116},[117,118],-80.19366,25.77427,{"lat":118,"lon":117},{"facility":121,"status":86,"city":122,"state":113,"zip":123,"country":76,"countryCode":77,"cosmosGeoPoint":124,"geoPoint":128,"contacts":20},"Sarasota Retina Institute - Research","Sarasota","34239",{"type":79,"coordinates":125},[126,127],-82.53065,27.33643,{"lat":127,"lon":126},{"facility":130,"status":86,"city":131,"state":132,"zip":133,"country":76,"countryCode":77,"cosmosGeoPoint":134,"geoPoint":138,"contacts":20},"Northwestern University - Ophthalmology","Chicago","Illinois","60611",{"type":79,"coordinates":135},[136,137],-87.65005,41.85003,{"lat":137,"lon":136},{"facility":140,"status":86,"city":131,"state":132,"zip":141,"country":76,"countryCode":77,"cosmosGeoPoint":142,"geoPoint":144,"contacts":20},"University of Illinois at Chicago Eye and Ear Infirmary - Ophthalmology","60612",{"type":79,"coordinates":143},[136,137],{"lat":137,"lon":136},{"facility":146,"status":86,"city":147,"state":148,"zip":149,"country":76,"countryCode":77,"cosmosGeoPoint":150,"geoPoint":154,"contacts":20},"Univ. Of Kentucky Clinic Dept of Ophthalmology & Vision Science","Lexington","Kentucky","40508",{"type":79,"coordinates":151},[152,153],-84.47772,37.98869,{"lat":153,"lon":152},{"facility":156,"status":86,"city":157,"state":158,"zip":159,"country":76,"countryCode":77,"cosmosGeoPoint":160,"geoPoint":164,"contacts":20},"The Johns Hopkins Hospital (JHH)","Baltimore","Maryland","21287",{"type":79,"coordinates":161},[162,163],-76.61219,39.29038,{"lat":163,"lon":162},{"facility":166,"status":86,"city":167,"state":168,"zip":169,"country":76,"countryCode":77,"cosmosGeoPoint":170,"geoPoint":174,"contacts":20},"Tufts Medical Center - Neurology","Boston","Massachusetts","02116",{"type":79,"coordinates":171},[172,173],-71.05977,42.35843,{"lat":173,"lon":172},{"facility":176,"status":86,"city":177,"state":178,"zip":179,"country":76,"countryCode":77,"cosmosGeoPoint":180,"geoPoint":184,"contacts":20},"University of Michigan Health - Kellogg Eye Center","Ann Arbor","Michigan","48105",{"type":79,"coordinates":181},[182,183],-83.74088,42.27756,{"lat":183,"lon":182},{"facility":186,"status":86,"city":187,"state":178,"zip":188,"country":76,"countryCode":77,"cosmosGeoPoint":189,"geoPoint":193,"contacts":20},"Trinity Health Grand Rapids","Grand Rapids","49503",{"type":79,"coordinates":190},[191,192],-85.66809,42.96336,{"lat":192,"lon":191},{"facility":195,"status":86,"city":196,"state":197,"zip":198,"country":76,"countryCode":77,"cosmosGeoPoint":199,"geoPoint":203,"contacts":20},"University of Minnesota, Dept of Ophthalmology","Minneapolis","Minnesota","55455",{"type":79,"coordinates":200},[201,202],-93.26384,44.97997,{"lat":202,"lon":201},{"facility":205,"status":72,"city":206,"state":197,"zip":207,"country":76,"countryCode":77,"cosmosGeoPoint":208,"geoPoint":212,"contacts":20},"Mayo Clinic - Department of Ophthalmology","Rochester","55905",{"type":79,"coordinates":209},[210,211],-92.4699,44.02163,{"lat":211,"lon":210},{"facility":214,"status":86,"city":215,"state":216,"zip":217,"country":76,"countryCode":77,"cosmosGeoPoint":218,"geoPoint":222,"contacts":20},"University of Pennsylvania - Ophthalmology","Philadelphia","Pennsylvania","19104",{"type":79,"coordinates":219},[220,221],-75.16362,39.95238,{"lat":221,"lon":220},{"facility":224,"status":72,"city":225,"state":226,"zip":227,"country":76,"countryCode":77,"cosmosGeoPoint":228,"geoPoint":232,"contacts":20},"Retina Consultants of South Carolina, Charleston Neuroscience Institute- West Ashley (RCA)","Charleston","South Carolina","29414",{"type":79,"coordinates":229},[230,231],-79.93275,32.77632,{"lat":231,"lon":230},{"facility":234,"status":86,"city":235,"state":236,"zip":237,"country":76,"countryCode":77,"cosmosGeoPoint":238,"geoPoint":242,"contacts":20},"Neuro Eye Clinical Trials","Houston","Texas","77074",{"type":79,"coordinates":239},[240,241],-95.36327,29.76328,{"lat":241,"lon":240},{"type":244,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","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":255,"type":256},272,"ESTIMATED","INTERVENTIONAL",[259],"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).",[262],"Non-Arteritic Anterior Ischemic Optic Neuropathy",[264,262,265,266,267,268],"Acute optic neuropathy","NAION","cenegermin","Optic neuropathy","Intranasal","2026-06-18",{"date":271,"type":272},"2026-06-22","ACTUAL",{"date":274,"type":256},"2026-06-30",{"date":276,"type":256},"2027-09",{"name":5,"class":6},18]