protocolSection identificationModule nctId: NCT06321562, orgStudyIdInfo id: EyeD-010-003, secondaryIdInfos id: 2020-002354-24, type: EUDRACT_NUMBER, secondaryIdInfos id: CIV-21-12-038426, type: OTHER, domain: EUDAMED, briefTitle: Safety and Tolerability of a Timolol Releasing Intraocular Implant in Subjects With Primary Open-angle Glaucoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2027-07, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: EyeD Pharma, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to test a new method to deliver an approved medicine called Timolol in the eye of participants with glaucoma and pseudophakia. The main questions it aims to answer are how safe the investigational drug is and how the body tolerates it.The study will also check:* how safely the implant is placed in and removed from the eye and how the body responds to the procedure,* how safe different doses of timolol are and how the body handles taking it,* the amount of Timolol released in the bloodstream,* if there is any positive effect on the pressure inside the eye., conditionsModule conditions: Primary Open-angle Glaucoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: TimoD implant, interventions name: Injector system, outcomesModule primaryOutcomes measure: Number and proportion of participants experiencing one or more serious adverse events (SAEs), primaryOutcomes measure: Number and proportion of participants experiencing one or more treatment-emergent adverse events (TEAEs) overall and by dose group, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU - Service d'Ophtalmologie, status: RECRUITING, city: Liège, zip: 4000, country: Belgium, contacts name: Nathalie Collignon, Prof. MD., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.63373, lon: 5.56749, locations facility: Breyer, Kaymak & Klabe Augenchirurgie, status: RECRUITING, city: Düsseldorf, zip: 40212, country: Germany, contacts name: Karsten Klabe, MD., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.22172, lon: 6.77616, locations facility: Universitäts-Augenklinik Heidelberg, status: NOT_YET_RECRUITING, city: Heidelberg, zip: 69120, country: Germany, contacts name: Gerd Auffarth, Prof. MD., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.40768, lon: 8.69079, locations facility: Universitätsaugenklinik Magdeburg, status: RECRUITING, city: Magdeburg, zip: 39120, country: Germany, contacts name: Giulia Reineri, MD., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.12773, lon: 11.62916, locations facility: Augenklinik Sulzbach, status: RECRUITING, city: Sulzbach, zip: 66280, country: Germany, contacts name: Karl Boden, MD., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.29882, lon: 7.05696, locations facility: Universitäts-Augenklinik Tübingen, status: RECRUITING, city: Tübingen, zip: 72076, country: Germany, contacts name: Bogomil Voykov, MD., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.52266, lon: 9.05222, hasResults: False