A Phase 1 Study of the Safety and Tolerability of a Single Intravitreal Injection of IGT001 in Adults with Retinitis Pigmentosa

What this Trial Is About

Researchers are conducting an open-label, single-center clinical study to evaluate the safety, tolerability, and possible effects of a single dose of IGT001 delivered by intravitreal injection in adults with retinitis pigmentosa. This study includes four dose groups based on concentration levels and aims to better understand how this treatment works in patients with this hereditary retinal disease. IGT001 is given as a one-time injection into the eye under local anesthesia. Participants are assigned to one of four groups with different dose concentrations. After the injection, they are monitored closely and discharged on the same day if their vision and eye pressure remain stable and no significant health issues arise. Each participant will be followed for one year, with an option to join an additional year-long follow-up to assess long-term safety and tolerability. During the study, participants will have regular check-ups including vision tests, eye pressure measurements, and laboratory tests such as blood samples for genetic and immune system analysis. The main outcomes measured include the occurrence of adverse events or serious adverse events over one year and dose-limiting toxicities within 28 days. This study lasts about one year with an optional extension for further monitoring of participants health and response to the treatment.

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