Age-Related Macular Degeneration
Conditions
Brief summary
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.
Interventions
DRUGKH631
KH631: AAV vector containing a coding sequence for an anti-VEGF protein
Sponsors
Chengdu Origen Biotechnology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 study written informed consent form (ICF); 2. Men and women ≥ 50 and ≤85 years of age, diagnosed with nAMD at the Screening visit; 3. Subjects must be under active anti-VEGF treatment for nAMD and received a minimum of 3 injections within 6 months prior to screening; 4. Response to anti-VEGF therapy(Response is defined as reduction in CRT≥50μm or at least 30% reduction in fluid by OCT compared to disease at the worst); 5. BCVA between ≤20/63 and ≥20/400(≤63 and ≥19 Early Treatment Diabetic Retinopathy Study \[ETDRS\] letters) for the first patient in each cohort followed by BCVA between ≤20/40 and ≥20/400(≤73 and ≥19 ETDRS letters) for the rest of the cohort; 6. Must be pseudophakic(at least 3 months after intraocular lens implantation) in the study eye; 7.Female subjects must have been postmenopausal for at least 1 year.
Exclusion criteria
* 1.Any other cause of CNV, including pathologic myopia, etc, or other diseases except nAMD have an influence on the test of macular or affect the central visual acuity; 2.Presence of an implant, refractive media opacity affects fundus examination or narrow pupil of the study eye; 3.Active or history of retinal detachment in the study eye; 4.Uncontrolled glaucoma or ocular hypertension; 5.Have taken the drug known to have retinal toxicity; 6.History of intraocular surgery; 7.Uncontrolled hypertension despite medication at the screening visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in best corrected visual acuity | 52 weeks | BCVA |
| Safety | 24 weeks | incidence of AEs and SAEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in best corrected visual acuity | 104 weeks | BCVA |
| Change in area of retinal leakage | 104 weeks | Leakage measured by FFA |
| Rescue injections | 104 weeks | Mean number of rescue injections |
| Change in central retinal thickness | 104 weeks | CRT |
| Safety | 104 weeks | incidence of AEs and SAEs |
Other
| Measure | Time frame | Description |
|---|---|---|
| KH631 protein in aqueous fluid and blood | 104 weeks | Exploratory |
| VEGF-A in aqueous fluid and blood | 104 weeks | Exploratory |
Countries
China
Contacts
Primary ContactQiang Zheng
Backup ContactShanshan Ji
Outcome results
None listed