Actively Recruiting
Safety and Efficacy of a Single Subretinal Injection of JWK002 Gene Therapy in Subjects With X-linked Retinoschisis(XLRS)
Led by West China Hospital · Updated on 2025-02-07
12
Participants Needed
1
Research Sites
523 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is to evaluate the safety and efficacy of JWK002 treatment of X-linked retinoschisis(XLRS). This study will enroll subjects aged 5-18 years old to receive a sub-retinal injection of JWK002.
CONDITIONS
Official Title
Safety and Efficacy of a Single Subretinal Injection of JWK002 Gene Therapy in Subjects With X-linked Retinoschisis(XLRS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully understand the trial purpose and agree to participate by signing informed consent
- Male, aged 5 to under 18 years at consent
- Clinically diagnosed with XLRS confirmed by RS1 gene mutation without other ophthalmic genetic mutations
- Best corrected visual acuity (BCVA) between 34 and 63 letters (Snellen 20/200 to 20/63) in the study eye
You will not qualify if you...
- Use of carbonic anhydrase inhibitors within 3 months
- Other eye conditions causing vision loss or affecting subretinal injection
- Lens, cornea, or refractive issues affecting retinal observation
- Eye conditions impacting study endpoints
- Internal eye surgery within past 6 months
- AAV8 neutralizing antibody titer 1:1000 or higher
- Previous gene or cell therapy
- Fertile subjects unwilling to use contraception
- Active infections or positive tests for hepatitis B, hepatitis C, syphilis, or HIV
- Malignant tumors diagnosed within 5 years before screening
- Current or past systemic immune system disease
- Significant abnormal lab values including liver enzymes, bilirubin, creatinine, or clotting times
- Severe or known allergies to study drugs or treatments
- Other conditions deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital
Chengdu, Sichuan, China, 610023
Actively Recruiting
Research Team
L
Licong Liang
CONTACT
K
Kaiqin She
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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