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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
FT-003
GeneticAdministered via intraocular injection.
Treatment groups
78 Participants
are divided into 3 treatment groupsGroup A: FT003 Dose 1Experimental treatment 1 intervention
Group B: FT003 Dose 2Experimental treatment 1 intervention
Group C: FT003 Dose 3Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and tolerability after FT-003 injection
Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0)
Time frame
At Week 12Secondary outcomes
1
To evaluate the efficacy after FT-003 injection
the BCVA and OCT change from baseline
Time frame
At Week 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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