An Open-label, Dose-ascending Study of IGT001 for Retinitis Pigmentosa

This is an investigator-initiated, prospective, single-center, open-label, single ascending dose clinical study. The study aims to evaluate the safety, tolerability, and potential efficacy of intravitreal injection of IGT001 in patients with retinitis pigmentosa across different dose groups. IGT001 is administered as a single intravitreal injection in the study eye under local anesthesia. Participants will be discharged on the day of treatment, provided that their visual acuity and intraocular pressure are close to baseline levels, and no clinically significant abnormalities in vital signs are observed compared to pre-injection values. The decision for discharge will be determined by the investigator's assessment.

NCT Number	NCT06936787
Lead Sponsor	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Conditions	Retinitis Pigmentosa
Enrollment	21 participants
Start Date	2025-04-20
Primary Completion	2025-12-20 (estimated)
Study Completion	2027-12-20 (estimated)
Updated on ClinicalTrials.gov	2025-04-27