Actively Recruiting
Safety and Tolerability of KH631 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
Led by Chengdu Origen Biotechnology Co., Ltd. · Updated on 2024-11-27
42
Participants Needed
1
Research Sites
203 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
KH631 is a adeno-associated virus (AAV) vector-based gene therapy for subretinal 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 KH631 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 the study written informed consent form (ICF)
- Men and women aged 50 to 85 years diagnosed with nAMD at screening
- Under active anti-VEGF treatment for nAMD with at least 3 injections within 6 months prior to screening
- Response to anti-VEGF therapy defined as reduction in central retinal thickness by 50 micrometers or at least 30% reduction in fluid by OCT compared to worst disease
- Best corrected visual acuity (BCVA) between 20/63 and 20/400 (63 to 19 ETDRS letters) for first patient in each cohort; BCVA between 20/40 and 20/400 (73 to 19 ETDRS letters) for other cohort members
- Must be pseudophakic (at least 3 months after intraocular lens implantation) in the study eye
- Female subjects must have been postmenopausal for at least 1 year
You will not qualify if you...
- Any other cause of choroidal neovascularization (CNV) including pathologic myopia or other diseases affecting macular or central visual acuity
- Presence of an implant, refractive media opacity affecting fundus examination, or narrow pupil in the study eye
- Active or history of retinal detachment in the study eye
- Uncontrolled glaucoma or ocular hypertension
- Use of drugs known to have retinal toxicity
- History of intraocular surgery
- Uncontrolled hypertension despite medication at screening visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Tongren Hospital, Capital Medical University
Beijing, China
Actively Recruiting
Research Team
Q
Qiang Zheng
CONTACT
S
Shanshan Ji
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
5
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