drugset / Trial / NCT06936787

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

NCT06936787 ↗

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2025-04-20
Primary completion
2025-12-20
Completion
2027-12-20

Drugs

EvaluationDrugModalityDoseRoute
Subject IGT001 Unknown 500000 unknown Intravitreal
Subject IGT001 Unknown 1e+06 unknown Intravitreal
Subject IGT001 Unknown 2e+06 unknown Intravitreal

Indications