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Gene Therapy Trial Browser
Clinical Trial Report
Gene Therapy Trial Report
Summary
Safety and Tolerability of KH658 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
NCTID
NCT06458595
(View at clinicaltrials.gov)
Description
KH658 is a adeno-associated virus (AAV) vector-based gene therapy for suprachoroidal space injection. The long-term, stable therapeutic protein after one time injection for nAMD could potentially reduce the treatment burden and maintain vision.
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Development Status
Active
Indication
Neovascular (Wet) Age-Related Macular Degeneration (nAMD)
Disease Ontology Term
DOID:10871
Compound Name
KH658
Sponsor
Chengdu Origen Biotechnology Co., Ltd.
Funder Type
Industry
Recruitment Status
Recruiting
Enrollment Count
44
Results Posted
Not Available
Therapy Information
Target Gene/Variant
Anti-VEGF
Therapy Type
Gene transfer
Therapy Route
In-vivo
Mechanism of Action
Genetic delivery of therapeutic protein
Route of Administration
Suprachoroidal
Drug Product Type
Viral vector
Target Tissue/Cell
Delivery System
Viral transduction
Vector Type
AAV
Editor Type
none
Dose 1
Undisclosed dose
Dose 2
Dose 3
Dose 4
Dose 5
Study Record Dates
Current Stage
Phase1, Phase2
Submit Date
2024-06-09
Completion Date
2026-12-28
Last Update
2024-11-29
Participation Criteria
Eligible Age
50 Years - 85 Years
Standard Ages
Adult, Older adult
Sexes Eligible for Study
ALL
Locations
No.of Trial Sites
1
Locations
China
Regulatory Information
Has US IND
False
FDA Designations
Recent Updates
Resources/Links
News and Press Releases
Kanghong Pharmaceutical (002773.SZ): Clinical trial of KH658 ophthalmic injection approved
Related NCTID
Phase 1: NCT06825858