UGX202 Injection in Patients With Advanced Retinitis Pigmentosa
ConditionRetinitis Pigmentosa (RP)
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSuzhou UgeneX Therapeutics Co., Ltd.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- UGX202 injection
Treatment groups
6 Participants
are divided into 2 treatment groupsSponsors and collaborators
Suzhou UgeneX Therapeutics Co., Ltd.
Lead sponsor
Eye & ENT Hospital of Fudan University
Collaborator
Source ClinicalTrials.gov