Phase I/II Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)

Prior treatment

• Current vitreous hemorrhage in the study eye or history of vitreous hemorrhage within 4 weeks prior to baseline;
• Any prior gene therapy.

Other illness

• 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;
• 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;

Other

• Retinal pigment epithelial tear in the study eye at screening;

• 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.