Actively Recruiting
Safety and Tolerability of KH658 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
Led by Chengdu Origen Biotechnology Co., Ltd. · Updated on 2024-11-29
44
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Tolerability of KH658 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to sign informed consent form
- Female or male aged 50 to 85 years with neovascular age-related macular degeneration (nAMD)
- Previously received anti-VEGF treatment for nAMD with documented response and at least 2 anti-VEGF injections in the study eye in the prior 6 months
- ETDRS BCVA letter score between 83 and 19 (about 20/25 to 20/400 Snellen equivalent) in the study eye at screening
- ETDRS BCVA letter score of 19 or more in the fellow eye at screening
- Females must be at least 1 year postmenopausal
You will not qualify if you...
- Other causes of choroidal neovascularization (CNV) in the study eye or non-nAMD disease affecting central vision
- Conditions preventing visual acuity improvement in the study eye such as fovea scar, fibrosis, or atrophy
- Subretinal hemorrhage covering 50% or more of the lesion area or blood greater than 1.0 mm2 under the fovea in the study eye at screening
- Any vitreous hemorrhage or history of vitreous hemorrhage in the study eye
- Presence of an implant (excluding intraocular lens), opacification of the refractive medium, or miosis affecting fundus examination
- History or presence of retinal detachment or choroidal detachment in the study eye
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Medical University General Hospital
Tianjin, China
Actively Recruiting
Research Team
J
Jiarong Du
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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