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This is a phase 1/2 clinical study to evaluate the safety, preliminary efficacy, immunogenicity, and pharmacokinetic (PK) characteristics of SKG0106 in subjects with nAMD. Based on results from the phase 1 dose escalation study, the phase 2 expansion study will be conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I: Low dose | Experimental | SKG0106 One-Time Intraocular Injection Dose Level 1 |
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| Phase I: Medium dose | Experimental | SKG0106 One-Time Intraocular Injection Dose Level 2 |
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| Phase I: High dose | Experimental | SKG0106 One-Time Intraocular Injection Dose Level 3 |
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| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Characteristics of dose limiting toxicities (DLTs) | 4 Weeks | |
| Type, severity, and incidence of ocular and systemic adverse events (AEs) | 52 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. | 52 Weeks |
| Mean change from baseline in central subfield thickness (CST) at each visit |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongqin Wang | Contact | +86 18616737445 | yongqin.wang@skytx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Vitreous Associates of Florida - Saint Petersburg | Not yet recruiting | St. Petersburg | Florida | 33711 | United States |
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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). |
| 52 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. | 52 Weeks |
| Ophthalmic Consultants of Boston | Recruiting | Boston | Massachusetts | 02114 | United States |
| Retina Consultants of Texas | Recruiting | Katy | Texas | 77494 | United States |
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| Wagner Kapoor Research Institute | Recruiting | Norfolk | Virginia | 23502 | United States |
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| The Second Hospital Of Anhui Medical University | Recruiting | Hefei | Anhui | China |
| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | Zhejiang | China |
| Eye Hospital, WMU (Zhejiang Eye Hospital) | Recruiting | Wenzhou | Zhejiang | China |
| Beijing Hospital | Recruiting | Beijing | China |
| Peking Union Medical College Hospital | Recruiting | Beijing | China |