Gene Therapy(FT-003) for Wet AMD

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

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06492863

Enrollment

Registered

2024-07-09

Start date

2023-08-15

Completion date

2028-10-15

Last updated

2024-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neovascular Age-related Macular Degeneration

Keywords

FT-003, nAMD

Brief 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.

Detailed description

FT-003 is a gene therapy product developed for the treatment of neovascular age-related macular degeneration (nAMD). Neovascular AMD is the main cause of blindness among elderly individuals. The available therapies for treating nAMD require life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. Administration of FT-003 has the potential to treat nAMD by providing durable expression of therapeutic levels of intraocular protein and maintaining the vision of patients. FT-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.

Interventions

GENETICFT-003

Administered via intraocular injection.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
To evaluate the efficacy after FT-003 injection	At Week 24	the BCVA and OCT change from baseline

Countries

China

Contacts

Primary ContactXinyan Li

xinyan.li@fronteratherapeutics.com86-021-58206061

Backup ContactMinghui Xue

minghui.xue@fronteratherapeutics.com86-021-58206061

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026