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.
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;
Diagnosis of nAMD as determined by the PI;
Active CNV lesions secondary to age-related macular degeneration (AMD);
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;
Skyline Therapeutics (US) Inc.
Lead sponsor