{ "data": { "asOf": "2026-10-30T22:24:36.783Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT07796646", "title": "Study to Evaluate the Long-Term Safety of Ultevursen in Participants With Retinitis Pigmentosa (RP) Due to Mutations in Exon 13 of the USH2A Gene", "scientificTitle": "An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Ultevursen in Participants With Retinitis Pigmentosa (RP) Due to Mutations in Exon 13 of the USH2A Gene", "status": "not_yet_recruiting", "studyType": "interventional", "phase": [ "PHASE2" ], "conditions": [ "Retinitis Pigmentosa (RP)", "Usher Syndrome Type 2", "Deaf Blind", "Retinal Disease", "Eye Diseases, Hereditary", "Eye Disorders Congenital", "Vision Disorders" ], "interventions": [ { "name": "No intervention, will not receive any active study intervention", "type": "OTHER", "description": "Observation only (no experimental drug administered)" }, { "name": "Intravitreal Injection of Ultevursen", "type": "DRUG", "description": "Participants will receive up to 4 doses over a 24-month period" } ], "sponsor": { "name": "Laboratoires Thea", "type": "INDUSTRY" }, "locations": [], "outcomes": { "other": [ "Percent change in EZ area (SD-OCT)", "Change in PRO domains (MRDQ)", "Change in Best Corrected Visual Acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study chart (ETDRS)", "Change in low luminance visual acuity (LLVA) using the Early Treatment Diabetic Retinopathy Study chart (ETDRS)", "Change in mean sensitivity at ≥5 pre specified MP loci", "Change in MP mean sensitivity", "Percent change in EZ width (SD-OCT)", "Change in PRO Domains (MVAQ)" ], "primary": [ "Incidence and severity of ocular adverse events (AEs), including serious AEs (SAEs) and adverse events of special interest (AESI)", "Incidence and severity of non-ocular AEs, including SAEs." ], "secondary": [] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n1. Participants who have completed the LUNA study through Month 24 and, in the Investigator's judgment, may benefit from continued treatment or observational follow-up\n2. Be adults (≥18 years old) who are able to provide informed consent OR minors (8 to \\<18 years old) providing assent with parental permission\n3. Participant (and/or parent/caregiver) willing and able to comply with the 24-month protocol, attend all study visits, and complete all assessments\n4. Treatment Cohort only: Non-pregnant and non-breastfeeding. Women of childbearing potential (WOCBP) and fertile males must use highly effective contraception\n\nExclusion Criteria:\n\n1. Treatment Cohort only: New ocular condition in the SE (e.g., severe infection, uncontrolled glaucoma, or retinal detachment) that, in the Investigator's opinion, makes the SE unsafe for IVT injection\n\n * Additionally, any ocular condition or AE in the fellow eye that, in the opinion of the Investigator, may impact participant safety or confound the assessment of the SE. Eligibility in such cases will be evaluated on a case-by-case basis.\n2. Treatment Cohort only: Known hypersensitivity to antisense oligonucleotides or any constituents of the injection\n3. Treatment Cohort only: Any clinically significant safety finding observed during the LUNA trial that, in the Investigator's opinion, compromises the participant's safety with continued dosing. Participants that have had study drug temporarily withdrawn or elective ocular surgery or AESI's during the LUNA trial may be reviewed on a case by case basis for eligibility into the Treatment Cohort (Note: These participants may still be eligible for the Observation Only Cohort at the Investigator's discretion and following discussion with medical monitor).\n4. Both cohorts: Presence of any significant ocular or systemic disease, or laboratory abnormality, that would increase participant risk irrespective of treatment or interfere with study assessments\n5. 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