UGX202 Gene Therapy Tested in Advanced Retinitis Pigmentosa
Tests a gene therapy eye injection for safety in adults with advanced retinitis pigmentosa.
Plain-language title generated from the registry record
Registry title: UGX202 Injection in Patients With Advanced Retinitis Pigmentosa
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Early phase 1
Where in China
- Eye ENT Hospital of Fudan UniversityShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Suzhou UgeneX Therapeutics Co., Ltd.
- Trial code
- NCT07311863
- Record updated
- 31 December 2025
- Original description
The primary objective of this clinical trial is to evaluate the safety and tolerability of a single intravitreal injection of the gene therapy drug UGX202 in patients with advanced RP. The secondary objective is, to assess the preliminary efficacy of a single intravitreal injection of the gene therapy drug UGX202 in treating patients with advanced RP.Read full original descriptionShow less
Study to Evaluate the Safety and Preliminary Efficacy of UGX202 Injection in Patients With Advanced Retinitis Pigmentosa
The primary objective of this clinical trial is to evaluate the safety and tolerability of a single intravitreal injection of the gene therapy drug UGX202 in patients with advanced RP. The secondary objective is, to assess the preliminary efficacy of a single intravitreal injection of the gene therapy drug UGX202 in treating patients with advanced RP.
Inclusion: Provide written informed consent form (ICF); Age ≥18 years at ICF signing; Diagnosed as non-syndromic RP;; BCVA > logMAR 1.9 (assessed by FrACT) in the study eye; Confirmation of preserved memory of visual experience; Spherical equivalent between -9D and +6D.
Exclusion: Prior gene therapy in either eye; Received any interventional investigational drug within 90 days prior to screening; Hypersensitivity to corticosteroids, intolerance to corticosteroid regimen, active concurrent infection contraindicating treatment; Any Study eye disease or systemic disease judged by the investigator to affect visual function assessment; History or tendency of psychiatric disorders impacting safety and/or efficacy assessment; Any other factor deemed unsuitable by the investigator.