Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KH631 Dose 1 | Experimental | dose1:Administered by Subretinal injection. Dosage form: injection solution. Dose: 200uL. Frequency of administration: one time injection. |
|
| KH631 Dose 2 | Experimental | dose2:Administered by Subretinal injection. Dosage form: injection solution. Dose: 200uL. Frequency of administration: one time injection. |
|
| KH631 Dose 3 | Experimental | dose3:Administered by Subretinal injection. Dosage form: injection solution. Dose: 200uL. Frequency of administration: one time injection. |
|
| KH631 Dose 4 | Experimental | dose4:Administered by Subretinal injection. Dosage form: injection solution. Dose: 200uL. Frequency of administration: one time injection. |
|
| KH631 Dose 5 | Experimental | dose5:Administered by Subretinal injection. Dosage form: injection solution. Dose: 200uL. Frequency of administration: one time injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KH631 | Drug | KH631: AAV vector containing a coding sequence for an anti-VEGF protein |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | incidence of AEs and SAEs | 24 weeks |
| Change in best corrected visual acuity | BCVA | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | incidence of AEs and SAEs | 104 weeks |
| Change in best corrected visual acuity | BCVA | 104 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| KH631 protein in aqueous fluid and blood | Exploratory | 104 weeks |
| VEGF-A in aqueous fluid and blood | Exploratory | 104 weeks |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiang Zheng | Contact | 86 13880331037 | zhengqiang@cnkh.com | |
| Shanshan Ji | Contact | 86 18188058101 | 022078@cnkh.com |
| Name | Affiliation | Role |
|---|---|---|
| Wenbin Wei, PhD | Beijing Tongren Hospital Affiliated to Capital Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital, Capital Medical University | Recruiting | Beijing | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Change in central retinal thickness | CRT | 104 weeks |
| Change in area of retinal leakage | Leakage measured by FFA | 104 weeks |
| Rescue injections | Mean number of rescue injections | 104 weeks |