An Open-Label Extension Study to Evaluate Safety & Tolerability of QR-421a in Subjects With Retinitis Pigmentosa
Stopped early · Phase 2
Conditions studied: Retinitis Pigmentosa, Usher Syndrome Type 2
In brief
PQ-421a-002 (Helia) is an open-label, extension study to evaluate the safety, tolerability and efficacy of QR 421a (ultevursen) administered via intravitreal (IVT) injection in one or both eyes, in subjects ≥ 12 years of age with RP due to mutations in exon 13 of the USH2A gene, for an anticipated period of 24 months, or until provision of continued treatment by other means is available, provided the subject's benefit-risk determination remains positive.
Key facts
- Study ID
- NCT05085964
- Run by
- Laboratoires Thea
- People needed
- 21
- Starts
- 2021-09-16
- Expected to finish
- 2022-10-18
- Last updated by the study team
- 2024-08-07
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Center for Clinical Research Operations, Massachusetts Eye and Ear — Boston, Massachusetts, United States
- University of Michigan, Kellogg Eye Center — Ann Arbor, Michigan, United States
- Casey Eye Institute, Oregon Health & Science University — Portland, Oregon, United States
- Retina Foundation of the Southwest — Dallas, Texas, United States
- Centre for Innovative Medicine, Department of Paediatric Surgery, Montreal Children's Hospital at the McGill University Health Centre — Montreal, Canada
- Hôpital Gui de Chauliac - CHRU de Montpellier - Maladies Sensorielles Génétique — Montpellier, France
- Centre de maladies rares CHNO des Quinze Vingts — Paris, France
Full record on ClinicalTrials.gov
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