protocolSection identificationModule nctId: NCT06275620, orgStudyIdInfo id: AGTC-RPGR-001 DAWN, briefTitle: A Study Comparing Two Doses of AGTC-501 in Male Participants With X-linked Retinitis Pigmentosa Caused by RPGR Mutations (DAWN), statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-11-14, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2029-08, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Beacon Therapeutics, class: INDUSTRY, descriptionModule briefSummary: This Phase 2 study is a non-randomized, open-label, study of the safety of AGTC-501 in participants with XLRP who have previously been treated with a full-length AAV vector-based gene therapy targeting RPGR protein., conditionsModule conditions: X-Linked Retinitis Pigmentosa, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: AGTC-501 (high dose and standard corticosteroid regimen), interventions name: AGTC-501 (low dose and standard corticosteroid regimen), interventions name: AGTC-501 (high dose and modified corticosteroid regimen), outcomesModule primaryOutcomes measure: The primary safety outcome is the number and proportion of participants experiencing Grade 3 or higher local (ocular) or non-ocular treatment-emergent adverse events, including treatment-emergent serious adverse events (SAEs)., secondaryOutcomes measure: Change from baseline in mean sensitivity across the whole grid, as measured by MAIA microperimetry, secondaryOutcomes measure: Response, as measured by MAIA microperimetry, where response is defined as a greater than or equal to 7 dB visual sensitivity improvement from baseline in at least 7 loci., secondaryOutcomes measure: Change from baseline in BCVA using Early-Treatment Diabetic Retinopathy Study (ETDRS) visual acuity, secondaryOutcomes measure: Change from baseline in LLVA using ETDRS visual acuity, secondaryOutcomes measure: Change from baseline in Ora-VNC mobility test score, eligibilityModule sex: MALE, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Florida, city: Jacksonville, state: Florida, zip: 32209, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Bascom Palmer Eye Institute, city: Miami, state: Florida, zip: 33136, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Boston Children's Hospital, city: Boston, state: Massachusetts, zip: 02115, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Cincinnati Eye Institute, city: Cincinnati, state: Ohio, zip: 45242, country: United States, geoPoint lat: 39.12713, lon: -84.51435, locations facility: Cleveland Clinic, city: Cleveland, state: Ohio, zip: 44195, country: United States, geoPoint lat: 41.4995, lon: -81.69541, locations facility: Casey Eye Institute, city: Portland, state: Oregon, zip: 97239, country: United States, geoPoint lat: 45.52345, lon: -122.67621, locations facility: Retina Foundation of the Southwest, city: Dallas, state: Texas, zip: 75231, country: United States, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False