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NCT07847723
Phase I/II Open-Label Trial of UGX202 for Advanced Retinitis Pigmentosa
Conditions: Retinitis Pigmentosa (RP)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 12
Sponsor: Suzhou UgeneX Therapeutics Co., Ltd.
Summary
This is a single-arm, open-label study employing a 3+3 dose escalation design to evaluate two UGX202 dose groups: the low-dose group (1.2×10¹¹ vg/eye) and the high-dose group (3.5×10¹¹ vg/eye). According to the "Dose Escalation Rule" (see below), each dose group comprised 3-6 study participants; thus, a total of 6-12 study participants were enrolled in this phase. Participants were enrolled in ascending order from the lowest to the highest dose; each study participant could participate in only one dose group (defined as having received the investigational drug - participants who had not received the drug were not considered to have participated in any dose group), and could not participate in multiple dose groups sequentially.
Eligibility Criteria
Inclusion Criteria
* The participant voluntarily signs the informed consent form (ICF).
* The participant is older than 18 years at the time of signing the ICF.
* The participant has a confirmed diagnosis of non-syndromic retinitis pigmentosa (RP)
* Best-corrected visual acuity (BCVA) in the study eye is \
Source: ClinicalTrials.gov (NCT07847723). StuddyBuddy aggregates publicly available trial information.