A Dose-escalation and Dose-expanded Phase I/II Clinical Study to Evaluate the Safety, and Efficacy of FT-003 in Subjects With DME
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 Diabetic Macular Edema (DME). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 74
Healthy Volunteers: f
View:
• Subjects that are willing and able to follow study procedures;
• Female or male patients 18-74 years old at the time of signing the ICF;
• Clinically diagnosed with CI-DME;
• 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
Mignhui Xue
minghui.xue@fronteratherapeutics.com
+86-021-58206061
Time Frame
Start Date: 2023-11-15
Estimated Completion Date: 2028-11-15
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
Leads: Frontera Therapeutics