[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632579":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":18,"locations":24,"responsibleParty":43,"collaborators":10,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":56,"maxAge":10,"enrollmentInfo":57,"targetDuration":10,"studyType":60,"phases":10,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":27,"whyStopped":10,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"University Hospital, Bonn","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Aging (healthy volunteers)",null,"Participants with no signs of AMD",{"label":13,"type":10,"description":14,"interventionNames":10},"Early AMD","Participants with early AMD",{"label":16,"type":10,"description":17,"interventionNames":10},"Intermediate AMD","Participants with intermediate AMD",[19],{"name":20,"role":21,"phone":22,"phoneExt":10,"email":23},"Maximilian Pfau, MD, FEBO","CONTACT","+49 228 287 15505","maximilian.pfau@ukbonn.de",[25],{"facility":26,"status":27,"city":28,"state":10,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Department of Ophthalmology, University Hospital Bonn","RECRUITING","Bonn","53127","Germany","DE",{"type":33,"coordinates":34},"Point",[35,36],7.09549,50.73438,{"lat":36,"lon":35},[39],{"name":40,"role":21,"phone":41,"phoneExt":10,"email":42},"Sophia Dithmar, MD","0228 28715505","Sophia.Dithmar@ukbonn.de",{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Maximilian Pfau","Prof. Dr. med. Maximilian Pfau","100632579","enhanced-vision-and-imaging-tests-for-enabling-treatment-trials-in-early-and-intermediate-amd-100632579",false,"NCT07515521","Enhanced Vision and Imaging Tests for Enabling Treatment Trials in Early and Intermediate AMD","EVITE-AMD","Inclusion Criteria:\n\n* Written informed consent.\n* All biological sexes and gender identities.\n* Age \\&gt;=18 years for healthy volunteers; age \\&gt;=55 years for participants with AMD.\n* Ability to understand German or English sufficiently for study information and procedures.\n\nAdditional Inclusion Criteria by Cohort:\n\nHealthy Volunteers:\n\n\\- No drusen \\>63 um and no subretinal drusenoid deposits in either eye.\n\nEarly AMD:\n\n\\- Study eye with drusen \\>63 um but \\\u003C125 um and no pigmentary changes.\n\nIntermediate AMD:\n\n\\- Study eye with drusen \\>125 um and\u002For pigmentary changes.\n\nExclusion Criteria:\n\n* Claustrophobia relevant to dark-adaptation procedures.\n* Hypersensitivity to indocyanine green or sodium iodide, iodine allergy, or hyperthyroidism.\n* Known pregnancy.\n* Study eye history of ocular surgery other than cataract surgery, YAG capsulotomy, or laser retinopexy.\n* Ocular disease in the study eye that could affect visual function testing in the opinion of the investigators.\n* Medical conditions or planned operations that could interfere with follow-up.\n* Inability to comply with study procedures or insufficient language skills in the study language.\n* Inability to provide informed consent.",true,"ALL","18 Years",{"count":58,"type":59},150,"ESTIMATED","OBSERVATIONAL","This monocentric prospective longitudinal observational study will validate fundus-tracked dark adaptometry as an endpoint for future treatment trials in early and intermediate age-related macular degeneration (AMD). The study will characterize normative cone- and rod-mediated dark adaptation parameters in healthy volunteers, assess test-retest reliability, quantify sensitivity to change over time, evaluate diagnostic and prognostic validity against AMD stage and structural progression, and investigate imaging-, biomarker-, and genetics-based determinants of impaired dark adaptation.",[63],"Age - Related Macular Degeneration (AMD)",[65],"AMD","2026-03-31",{"date":68,"type":69},"2026-04-07","ACTUAL",{"date":71,"type":69},"2026-02-15",{"date":73,"type":59},"2028-12-15",{"name":45,"class":6},1]