drugset / Trial / NCT06936787
An Open-label, Dose-ascending Study of IGT001 for Retinitis Pigmentosa
Phase 1
Recruiting
21 enrolled
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IGT001 | Unknown | 500000 unknown | Intravitreal |
| Subject | IGT001 | Unknown | 1e+06 unknown | Intravitreal |
| Subject | IGT001 | Unknown | 2e+06 unknown | Intravitreal |