protocolSection identificationModule nctId: NCT06388200, orgStudyIdInfo id: OCU400-301, briefTitle: A Phase 3 Study Of OCU400 Gene Therapy for the Treatment Of Retinitis Pigmentosa, acronym: liMeliGhT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-26, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2026-10-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Ocugen, class: INDUSTRY, descriptionModule briefSummary: This is a Phase 3 study to Assess the Efficacy, Safety and Tolerability of OCU400 in patients with retinitis pigmentosa (RP) associated with RHO mutations and patients with any other RP associated mutation with a clinical phenotype of RP.This is a multicenter, assessor blinded and randomized study which will enroll 150 subjects., conditionsModule conditions: Retinitis Pigmentosa, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: This is outcome assessor blinded study, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Sub-Retinal Administration of OCU400-301, outcomesModule primaryOutcomes measure: Number of participants with change in functional vision in the study eye of RP subjects as assessed by LDNA, primaryOutcomes measure: Number of participants with change in functional vision in the study eye in Gene Agnostic group as assessed by LDNA, secondaryOutcomes measure: Number of participants with change in functional vision in the all treated eyes of RP subjects as assessed by LDNA, secondaryOutcomes measure: Number of participants with change in functional vision in the all treated eyes of subjects in Gene Agnostic Arm as assessed by LDNA, secondaryOutcomes measure: Number of participants with change in visual function in subjects with RHO mutation as assessed by LLVA letter score, secondaryOutcomes measure: Number of participants with change in visual function in Gene Agnostic Arm as assessed by LLVA letter scores, secondaryOutcomes measure: Ocular and non-ocular Events, otherOutcomes measure: Patients Global Impression of Change (PGIC) score, eligibilityModule sex: ALL, minimumAge: 8 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Associated Retina Consultants, status: RECRUITING, city: Phoenix, state: Arizona, zip: 85020, country: United States, contacts name: Mallory Mintert, MS, role: CONTACT, phone: 480-999-5458, email: Mallory.mintert@doctrials.com, contacts name: Jillian Bollinger, BS, role: CONTACT, phone: 480-999-5458, email: Jillian.bollinger@doctrials.com, contacts name: Benjamin Bakall, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.44838, lon: -112.07404, locations facility: Retina Consultants of Texas, status: NOT_YET_RECRUITING, city: Bellaire, state: Texas, zip: 77401, country: United States, contacts name: Rebbeca C Taing, role: CONTACT, phone: 713-524-3434, email: rebbecca.taing@retinaconsultantstexas.com, contacts name: Kenneth C Fan, M.D, MBA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.70579, lon: -95.45883, hasResults: False