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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
Development Status Active
Indication Neovascular (Wet) Age-Related Macular Degeneration (nAMD)
Disease Ontology Term DOID:10871
Drug Product Name KH658
Sponsor Chengdu Origen Biotechnology Co., Ltd.
Funder Type Industry
Recruitment Status
Enrollment Count 44 (ESTIMATED)
Results Posted Not Available

Therapy Information


Target Gene/Variant Anti-VEGF
Therapeutic Modality Gene transfer
Therapy Route in vivo
Mechanism of Action Genetic delivery of therapeutic protein
Route of Administration Suprachoroidal
Drug Product Type Viral vector
Gene Delivery System Type Viral transduction
Vector Type AAV
Dose 1 Undisclosed dose

Study Record Dates


Current Phase 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
Eligibility Criteria
Inclusion Criteria: 1. Are willing and able to sign the informed consent form (ICF); 2. Female and male aged 50 to 85 years (inclusive) with nAMD; 3. Have previously received anti-VEGF treatment for nAMD, with documented response to anti-VEGF therapy and a minimum of 2 anti-VEGF IVT injections in the study eye in the 6 months prior to screening; 4. Have a ETDRS BCVA letter score of 83 to 19 (approximately 20/25 to 20/400 Snellen equivalent) in the study eye at Screening; 5. Have a ETDRS BCVA letter score of ≥19 in the fellow eye at Screening; 6. Females must be at least 1 year postmenopausal. Exclusion Criteria: 1. Have any other cause of CNV (such as pathological myopia, etc.) in the study eye; or non-nAMD disease in the study eye judged by the investigator that could impact macular examination or affect central vision (such as diabetic retinopathy, central retinal vein occlusion, etc.); 2. Any condition preventing visual acuity improvement in the study eye, e.g. fovea scar, fibrosis or atrophy; 3. Have a subretinal hemorrhage that is either 50% or more of the total lesion area, or blood is greater than 1.0 mm2 under the fovea in the study eye at screening; 4. Have any vitreous hemorrhage or history of vitreous hemorrhage in the study eye; 5. Presence of an implant (excluding intraocular lens), opacification of the refractive medium or miosis that affects fundus examination; 6. Have a history of or presence of retinal detachment or choroidal detachment in the study eye.
View Inclusion and Exclusion Criteria at ClinicalTrials.gov

Locations


No.of Trial Sites 1
Locations China

Regulatory Information


Has US IND False
FDA Designations
Recent Updates First patient dosed in May 2025 at a US site (trial ID: NCT06825858)

Resources/Links