UGX202 injection: Comparison of different dosages of UGX202
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* Prior gene therapy in either eye.
* Received any interventional investigational drug within 90 days prior to screening.
* Any Study eye disease or systemic disease judged by the investigator to affect visual function assessment.
* Hypersensitivity to corticosteroids, intolerance to corticosteroid regimen, active concurrent infection contraindicating treatment.
* History or tendency of psychiatric disorders impacting safety and/or efficacy assessment.
* Any other factor deemed unsuitable by the investigator.
Primary outcome measure(s)
Incidence of adverse events and serious adverse events — baseline to Day 3, Day 7, Week 2, Week 4, Week 6, Week 8, Week 12, Week 24, Week 36, Week 52 From the time of administration of UGX202 injection until the 52nd week, based on the topical and systemic safety data, the incidence rates of AEs, TEAEs during treatment, TRAEs related to the study drug, TRAEs related to the study procedures, SAEs, TRSAEs related to the study drug, and TRSAEs related to the study procedures during the study period were summarized by the investigators, and the correlations between AEs and the study drug and study procedures were determined.
The average change in IOP — baseline to Day 3, Day 7, Week 2, Week 4, Week 6, Week 8, Week 12, Week 24, Week 36, Week 52 The average change in IOP of the study eyes and non-study eyes from after treatment to the 52nd week compared to the baseline. The IOP was measured three times consecutively at each visit and the average value was taken.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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