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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06458595
Other study ID # KH658-40101
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date June 28, 2024
Est. completion date December 28, 2026

Study information

Verified date June 2024
Source Chengdu Kanghong Pharmaceutical Group Co., Ltd.
Contact Ting Hu
Phone +8613880999215
Email huting@cnkh.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 44
Est. completion date December 28, 2026
Est. primary completion date March 31, 2026
Accepts healthy volunteers No
Gender All
Age group 50 Years to 85 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
KH658
KH658 Ophthalmic Injection

Locations

Country Name City State
China Tianjin Medical University General Hospital Tianjin

Sponsors (1)

Lead Sponsor Collaborator
Chengdu Origen Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tolerability and safety of KH658 in different dose levels Week 4, Week 26
Primary Change in BCVA letter Week 26
Secondary Incidence of adverse events and adverse reactions Week 4, 26, 38, 54
Secondary Efficacy (BCVA, CRT) Week 38, 54
Secondary Number of supplemental injections Week 54
Secondary Annualized rate of supplemental injections Week 54
Secondary Percentage of subjects free of rescue IVT therapy Week 54
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