Gene Therapy(FT-003) for Wet AMD
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age50-80
SponsorFrontera Therapeutics
About this trial
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 criteria
Qualifiers
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
Disqualifiers
•Presence of any other intraocular diseases other than nAMD in the studied eye that would affect the improvement of visual acuity and require treatment during the study for prevention or treatment of visual loss, as judged by the investigator.
Trial design
Treatments tested in this trial
- FT-003
Treatment groups
78 Participants
are divided into 3 treatment groupsSponsors and collaborators
Frontera Therapeutics
Lead sponsor
Tianjin Medical University Eye Hospital
Collaborator
The First Affiliated Hospital of Soochow University
Collaborator
Peking Union Medical College Hospital
Collaborator
Beijing Hospital
Collaborator
Source ClinicalTrials.gov