🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06458595
Recruiting Phase 1/2

Safety and Tolerability of KH658 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)

NCT06458595 · tracked via the Priya Life Science China tracker
Sponsor
Chengdu Origen Biotechnology Co., Ltd.
Phase
Phase 1/2
Started
2024-06-28
Last updated
2024-11-29

Condition(s) studied

Age-related Macular Degeneration

Investigational drug(s) / intervention(s)

KH658

KH658: KH658 Ophthalmic Injection

Study summary

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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Tianjin Medical University General Hospital Tianjin China Recruiting

More Chengdu Origen Biotechnology Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06458595 on ClinicalTrials.gov ↗ ← All trials in China