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
This is a clinical study to evaluate the safety, preliminary efficacy, immunogenicity of SKG0106 in subjects with nAMD.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Level 1 | Experimental | SKG0106 One-Time Intraocular Injection Dose Level 1 |
|
| Dose Level 2 | Experimental | SKG0106 One-Time Intraocular Injection Dose Level 2 |
|
| Dose Level 3 | Experimental | SKG0106 One-Time Intraocular Injection Dose Level 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SKG0106 | Genetic | SKG0106 is a recombinant adeno-associated virus (AAV) vector-based in vivo gene therapeutic product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Characteristics of dose limiting toxicities (DLTs) | 4 weeks | |
| Type, severity, and incidence of ocular and systemic adverse events (AEs) | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in best corrected visual acuity (BCVA) at each visit BCVA of the study eye is examined by the Early Treatment of Diabetic Retinopathy Study (ETDRS) testing at screening and baseline. | 24 weeks | |
| Mean change from baseline in central subfield thickness (CST) at each visit Spectral domain optical coherence tomography (SD-OCT) will be performed to measure CST at screening and at each visit (prior to study drug injection, if available). |
Not provided
Inclusion Criteria:
Voluntary and able to sign a dated ICF prior to any study-related procedures and able to complete the study as required by the protocol;
Aged ≥ 50 years at screening;
Study Eye:
Diagnosis of nAMD as determined by the PI;
Active CNV lesions secondary to age-related macular degeneration (AMD);
Subjects must have been responsive to anti-VEGF therapy as assessed by the PI prior to study treatment
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Youchen Chen | Contact | 13801025972 | chenyouxinpumch@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Youchen Chen | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 24 weeks |
| Mean change from baseline in patient-reported outcome (VFQ-25) scale score at each visit Both the total scale and subscale scores of the VFQ-25 is ranging from 0 to 100, and higher scores mean a better outcome. | 48 weeks |
| Eye & ENT Hospital of Fudan University | Recruiting | Shanghai | China |
|
| Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineXin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | China |