Phase I/II Study to Evaluate the Safety and Preliminary Efficacy of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Genetic
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:
• 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.
Locations
United States
Florida
Retina Vitreous Associates of Florida - Saint Petersburg
NOT_YET_RECRUITING
St. Petersburg
Massachusetts
Ophthalmic Consultants of Boston
RECRUITING
Boston
Texas
Retina Consultants of Texas
RECRUITING
Katy
Virginia
Wagner Kapoor Research Institute
RECRUITING
Norfolk
Other Locations
China
Beijing Hospital
RECRUITING
Beijing
Peking Union Medical College Hospital
RECRUITING
Beijing
Zhejiang Provincial People's Hospital
RECRUITING
Hangzhou
The Second Hospital Of Anhui Medical University
RECRUITING
Hefei
Eye Hospital, WMU (Zhejiang Eye Hospital)
RECRUITING
Wenzhou
Contact Information
Primary
Yongqin Wang
yongqin.wang@skytx.com
+86 18616737445
Time Frame
Start Date: 2024-02-23
Estimated Completion Date: 2026-01-30
Participants
Target number of participants: 68
Treatments
Experimental: Phase I: Low dose
SKG0106 One-Time Intraocular Injection Dose Level 1
Experimental: Phase I: Medium dose
SKG0106 One-Time Intraocular Injection Dose Level 2
Experimental: Phase I: High dose
SKG0106 One-Time Intraocular Injection Dose Level 3
Related Therapeutic Areas
Sponsors
Leads: Skyline Therapeutics (US) Inc.