Clinical Study on the Safety and Efficacy of JWK002 Injection Administered as a Single Subretinal Injection in Subjects With X-linked Retinoschisis
Sponsor study identifier
interventional
12
1 country
1
Study Start
November 17, 2023
Actual (reported)Primary Completion
November 30, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 30, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 17, 2023
Actual (reported)March 28, 2024
Actual (reported)April 3, 2024
Actual (reported)November 30, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 30, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Safety(Participants With Ocular and Non-ocular AEs (Adverse Events) and SAEs (Serious Adverse Events)
The primary outcome measures are safety, determined by the number of ocular and non-ocular Study Drug-related adverse events (SDAE), treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
baseline to day 7, day 14, month 1, 3, 6, 12
Best corrected visual acuity (BCVA)
baseline to day 7, day 14, month 1, 2, 3, 6, 12
Full-field electroretinogram(ff-ERG)
baseline to month 1, 3, 6, 12
Macular structure as assessed by swept source optical coherence tomography
baseline to month 1, 3, 6, 12
Visual field
baseline to month 1, 3, 6, 12
Subretinal injection low dose of JWK002 in one eye
Subretinal injection medium dose of JWK002 in one eye
Subretinal administration of gene therapy vector JWK002 to one eye.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
West China Hospital
Chengdu, Sichuan, 610023, China
Fang Lu
lufang@wchscu.cn
First Submitted
March 28, 2024
First Posted
April 3, 2024
Study Start
November 17, 2023
Actual (reported)Primary Completion
November 30, 2033
EstimatedClinical Evaluation of Patients With X-linked Retinoschisis
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 30, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 7, 2025
Record last verified: 2025-02
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Source: ClinicalTrials.gov.
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