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Clinical Trials in China / NCT06492863
Recruiting Phase 1/2

Gene Therapy(FT-003) for Wet AMD

NCT06492863 · tracked via the Priya Life Science China tracker
Sponsor
Frontera Therapeutics
Phase
Phase 1/2
Started
2023-08-15
Last updated
2024-07-09

Condition(s) studied

Neovascular Age-related Macular Degeneration

Investigational drug(s) / intervention(s)

FT-003

FT-003: Administered via intraocular injection.

Study 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

Sex
ALL
Min age
50 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * 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; Exclusion Criteria: * •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.

Primary outcome measure(s)

  • Safety and tolerability after FT-003 injection — At Week 12
    Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0)

Trial sites (1)

FacilityCityRegionStatus
Tianjin Medical University Eye Hospital Tianjin Tianjin,China Recruiting

More Frontera Therapeutics trials in China

Gene Therapy for Subjects With RPGR Mutation-associated X-linked Retinitis Pigmentosa Recruiting
Gene Therapy in Subjects With Biallelic RPE65 Mutation-associated Retinal Dystrophy Recruiting
Gene Therapy for Diabetic Macular Edema Recruiting
Gene Therapy for DME Recruiting

Other trials for the same condition

Safety and Efficacy of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (VENUS) Active, not recruiting
Safety and Efficacy Evaluation of LX111 Gene Therapy in nAMD Patients Recruiting
Safety and Efficacy of RRG001 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD) Recruiting
TAB014 Compared to Lucentis® in Patients with Neovascular Age-related Macular Degeneration Active, not recruiting
LX102 in Patients With Neovascular Age-Related Macular Degeneration (nAMD) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06492863 on ClinicalTrials.gov ↗ ← All trials in China