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RECRUITING
NCT05986864
PHASE1/PHASE2

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

Sponsor: Skyline Therapeutics (US) Inc.

View on ClinicalTrials.gov

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

GENETIC

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