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

NCTID	NCT05986864 (View at clinicaltrials.gov)
Description	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. (Show More)
Development Status	Active
Indication	Neovascular (Wet) Age-Related Macular Degeneration (nAMD)
Disease Ontology Term	DOID:10871
Compound Name	SKG0106
Sponsor	Skyline Therapeutics (US) Inc.
Funder Type	Industry
Recruitment Status	Recruiting (Click here for study contact information)
Enrollment Count	68
Results Posted	Not Available

Target Gene/Variant	Anti-VEGF
Therapy Type	Gene transfer
Therapy Route	In-vivo
Mechanism of Action	Genetic delivery of therapeutic protein
Route of Administration	Intravitreal
Drug Product Type	Viral vector
Target Tissue/Cell
Delivery System	Viral transduction
Vector Type	AAV
Editor Type	none
Dose 1	8E9 vg/eye
Dose 2	2.4E10 vg/eye
Dose 3	7.2E10 vg/eye
Dose 4
Dose 5

No.of Trial Sites	9
Locations	United States,China

Has US IND	True
FDA Designations
Recent Updates	Therapy is also under development to treat diabetic macular edema