Actively Recruiting
An Open-label, Dose-ascending Study of IGT001 for Retinitis Pigmentosa
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2025-04-27
21
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Open-label, Dose-ascending Study of IGT001 for Retinitis Pigmentosa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 218 years at the time of signing the informed consent form, regardless of gender
- Clinical diagnosis of retinitis pigmentosa based on medical history and specialized examinations
- Willing to undergo genetic mutation testing with results confirming known genetic mutations related to hereditary retinal degeneration
- Willing to provide blood samples for HLA typing
- Blood cell counts within normal range or deemed clinically insignificant by the investigator
- Negative screening for hepatitis B, hepatitis C, and HIV, with no history of drug abuse
- Female participants of childbearing potential must have a negative urine pregnancy test before injection
- Participants of childbearing potential must use medically approved contraception for at least 30 days before treatment and one year after treatment
You will not qualify if you...
- Study eye has other conditions affecting central vision or increasing safety risks
- Study eye cannot rule out pseudoretinitis pigmentosa or cancer-associated retinopathies
- History of malignant tumors except remission over five years or basal cell carcinoma
- End-stage major organ diseases or serious chronic conditions requiring continuous systemic treatment
- History or diagnosis of glaucoma or ocular hypertension in either eye
- Intraocular pressure above 21 mmHg or use of pressure-lowering medications
- History of allergies or adverse reactions to study procedures or medications including contrast agents, DMSO, gentamicin
- History of ocular surface damage or drug-induced toxicity from specific medications
- Inability or unwillingness to comply with study procedures including genetic testing, blood sampling, and eye examinations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital, Shanghai Jiao Tong University
Shanghai, China, 200080
Actively Recruiting
Research Team
X
Xiao Dong Sun, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here