RecruitingPhase 1NCT06213038

A Clinical Study Evaluating the Safety and Efficacy of SKG0106 in Patients With Neovascular Age-related Macular Degeneration (nAMD)

An Open-label, Dose-escalation Study to Evaluate the Safety, Preliminary Efficacy, Immunogenicity and Pharmacokinetic Characteristics of SKG0106 Intraocular Solution After Single Intravitreal Injection in Chinese Patients With Neovascular (Wet) Age-related Macular Degeneration

Sponsor

Youxin Chen

Enrollment

12 participants

Start Date

May 5, 2023

Study Type

INTERVENTIONAL

Conditions

Neovascular Age-related Macular Degeneration

Summary

This is a clinical study to evaluate the safety, preliminary efficacy, immunogenicity of SKG0106 in subjects with nAMD.

Eligibility

Min Age: 50 Years

Inclusion Criteria6

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 Criteria6

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.

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Interventions

GENETICSKG0106

SKG0106 is a recombinant adeno-associated virus (AAV) vector-based in vivo gene therapeutic product

Locations(3)

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

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NCT06213038