Status:
RECRUITING
A Clinical Study Evaluating the Safety and Efficacy of SKG0106 in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Lead Sponsor:
Youxin Chen
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief Summary
This is a clinical study to evaluate the safety, preliminary efficacy, immunogenicity of SKG0106 in subjects with nAMD.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06213038
Start Date
May 5 2023
End Date
May 30 2025
Last Update
January 8 2025
Active Locations (3)
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1
Peking Union Medical College Hospital
Beijing, China
2
Eye & ENT Hospital of Fudan University
Shanghai, China
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