Age-related Macular Degeneration
Conditions
Brief 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.
Interventions
DRUGKH658
KH658 Ophthalmic Injection
Sponsors
Chengdu Origen Biotechnology Co., Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability and safety of KH658 in different dose levels | Week 4， Week 26 |
| Change in BCVA letter | Week 26 |
Secondary
| Measure | Time frame |
|---|---|
| Number of supplemental injections | Week 54 |
| Incidence of adverse events and adverse reactions | Week 4， 26， 38， 54 |
| Percentage of subjects free of rescue IVT therapy | Week 54 |
| Annualized rate of supplemental injections | Week 54 |
| Efficacy (BCVA, CRT) | Week 38， 54 |
Countries
China
Contacts
Primary ContactJiarong Du
Outcome results
None listed