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Tests treatment safety and results for X Linked Retinoschisis
Official title Safety and Efficacy of a Single Subretinal Injection of JWK002 Gene Therapy in Subjects With X-linked Retinoschisis(XLRS)
ClinicalTrials.gov ID: NCT06345898
What this study is testing
What is JWK002?
JWK002 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for x linked retinoschisis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 18, men only
You may be able to join if
- Fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign the informed consent, and be able...
- Male, ≥5 years old and \< 18 years old (subject to the date of signing the informed consent);
- Clinically diagnosed XLRS, identified by genetic testing as RS1 gene mutation, and do not carry other mutations causing ophthalmic genetic diseases;
- Best corrected visual acuity (BCVA) of the study eye ≤63 letters (equivalent to Snellen 20/63); Best corrected visual acuity (BCVA) ≥34 letters...
You likely can't join if
- Carbonic anhydrase inhibitor treatment within 3 months;
- The presence of other conditions in the study eye that may cause vision loss (e.g., atrophy of the optic nerve, advanced glaucoma, uveitis, the...
- Those who study the retinal observation and examination caused by lens, cornea or other refractive interstitial turbidity;
- There are eye conditions affecting subretinal injection or eye conditions affecting the determination of the study endpoint;
- Patients who had undergone internal eye surgery within 6 months;
- Patients with AAV8 neutralizing antibody titer ≥1:1000;
See the full eligibility criteria
- Fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign the informed consent, and be able to cooperate with the testing required in various studies according to...
- Male, ≥5 years old and \< 18 years old (subject to the date of signing the informed consent);
- Clinically diagnosed XLRS, identified by genetic testing as RS1 gene mutation, and do not carry other mutations causing ophthalmic genetic diseases;
- Best corrected visual acuity (BCVA) of the study eye ≤63 letters (equivalent to Snellen 20/63); Best corrected visual acuity (BCVA) ≥34 letters (equivalent to Snellen 20/200).
- Carbonic anhydrase inhibitor treatment within 3 months;
- The presence of other conditions in the study eye that may cause vision loss (e.g., atrophy of the optic nerve, advanced glaucoma, uveitis, the presence of vesicular splitting chambers or vesicular retinal detachment...
- Those who study the retinal observation and examination caused by lens, cornea or other refractive interstitial turbidity;
- There are eye conditions affecting subretinal injection or eye conditions affecting the determination of the study endpoint;
- Patients who had undergone internal eye surgery within 6 months;
- Patients with AAV8 neutralizing antibody titer ≥1:1000;
- Have previously received any gene therapy or cell therapy;
- fertile people are unwilling to use contraception;
- The presence of any of the following: an active infection that the investigator believes may affect the patient's participation in the study or affect the study results that requires systematic treatment; Hepatitis B...
- Malignant tumors (basal cell or squamous cell skin cancer) were diagnosed within 5 years prior to screening;
- has or has had a systemic immune system disease;
- Laboratory values considered to be clinically significant were abnormal: alanine and/or aspartate transaminase \>2.5×ULN, total bilirubin \>1.5×ULN, serum creatinine \>1.5×ULN, prothrombin time ≥1.5×ULN, activated...
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 5 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.