A Dose-escalation and Dose-expanded Phase I/II Clinical Study to Evaluate the Safety, and Efficacy of FT-003 in Subjects With Wet AMD
Status: Recruiting
Location: See location...
Intervention Type: Genetic
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of disposable vitreous injection of FT-003 in subjects with neovascular age-related Macular Degeneration (nAMD). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:
• Subjects that are willing and able to follow study procedures;
• Female or male patients 50-80 years old at the time of signing the ICF;
• Clinically diagnosed with nAMD;
• Presence of active CNV
• The best corrected visual acuity (BCVA) of the studied eye is 24-73 letters;
Locations
Other Locations
China
Tianjin Medical University Eye Hospital
RECRUITING
Tianjin
Contact Information
Primary
Xinyan Li
xinyan.li@fronteratherapeutics.com
86-021-58206061
Backup
Minghui Xue
minghui.xue@fronteratherapeutics.com
86-021-58206061
Time Frame
Start Date: 2023-08-15
Estimated Completion Date: 2028-10-15
Participants
Target number of participants: 78
Treatments
Experimental: FT003 Dose 1
Low dose of FT-003
Experimental: FT003 Dose 2
Mid dose of FT-003
Experimental: FT003 Dose 3
High dose of FT-003
Related Therapeutic Areas
Sponsors
Collaborators: Peking Union Medical College Hospital, Tianjin Medical University Eye Hospital, The First Affiliated Hospital of Soochow University, Beijing Hospital
Leads: Frontera Therapeutics