NCT07311863Not yet recruitingEarly phase 1
UGX202 Injection in Patients With Advanced Retinitis Pigmentosa
Study to Evaluate the Safety and Preliminary Efficacy of UGX202 Injection in Patients With Advanced Retinitis Pigmentosa
Source: ClinicalTrials.gov · Last updated 31 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- First submitted
- 14 Nov 2025
- Start date
- Jan 2026
- Primary completion date
- Mar 2027
- Lead sponsor
- Suzhou UgeneX Therapeutics Co., Ltd.
- Diseases
- Retinitis pigmentosa
- NCT number
- NCT07311863
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 6
- From Jan 2026 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Any other factor deemed unsuitable by the investigator.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Eye ENT Hospital of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.