A Clinical Study Evaluating the Safety and Efficacy of SKG0106 in Patients With Neovascular Age-related Macular Degeneration (nAMD)
- Conditions
- Neovascular Age-related Macular Degeneration
- Interventions
- Genetic: SKG0106
- Registration Number
- NCT06213038
- Lead Sponsor
- Youxin Chen
- Brief Summary
This is a clinical study to evaluate the safety, preliminary efficacy, immunogenicity of SKG0106 in subjects with nAMD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 12
-
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
- Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in the study eye at baseline;
- Retinal pigment epithelial tear in the study eye at screening;
- Current vitreous hemorrhage in the study eye or history of vitreous hemorrhage within 4 weeks prior to baseline;
- Any condition that, in the opinion of the investigator, may limit visual acuity improvement in the study eye;
- History of retinal detachment or active retinal detachment in the study eye;
- Any prior gene therapy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dose Level 3 SKG0106 SKG0106 One-Time Intraocular Injection Dose Level 3 Dose Level 1 SKG0106 SKG0106 One-Time Intraocular Injection Dose Level 1 Dose Level 2 SKG0106 SKG0106 One-Time Intraocular Injection Dose Level 2
- Primary Outcome Measures
Name Time Method Characteristics of dose limiting toxicities (DLTs) 4 weeks Type, severity, and incidence of ocular and systemic adverse events (AEs) 48 weeks
- Secondary Outcome Measures
Name Time Method 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). 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
Trial Locations
- Locations (3)
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineXin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, China
Peking Union Medical College Hospital
🇨🇳Beijing, China
Eye & ENT Hospital of Fudan University
🇨🇳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🇨🇳Shanghai, China