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Phase I/II Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Sponsor: Skyline Therapeutics (US) Inc.
Summary
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.
Official title: Phase I/II Study to Evaluate the Safety and Preliminary Efficacy of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
68
Start Date
2024-02-23
Completion Date
2026-01-30
Last Updated
2025-01-09
Healthy Volunteers
No
Interventions
SKG0106
SKG0106 is a recombinant adeno-associated virus (AAV) vector-based in vivo gene therapeutic product
Locations (9)
Retina Vitreous Associates of Florida - Saint Petersburg
St. Petersburg, Florida, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Retina Consultants of Texas
Katy, Texas, United States
Wagner Kapoor Research Institute
Norfolk, Virginia, United States
The Second Hospital Of Anhui Medical University
Hefei, Anhui, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Eye Hospital, WMU (Zhejiang Eye Hospital)
Wenzhou, Zhejiang, China
Beijing Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China