Gene Therapy for Wet AMD

An Open-label, Single-center, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FT-003 in Subjects With Neovascular Age-related Macular Degeneration

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05611424

Enrollment

Registered

2022-11-10

Start date

2023-05-01

Completion date

2027-12-30

Last updated

2023-04-26

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

Brief summary

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

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Neovascular Age-related Macular Degeneration

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subjects that are willing and able to follow study procedures; * Female or male patients ≥45 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 ≤ 53 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 52	Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0)

Secondary

Measure	Time frame
Changes in best-corrected visual acuity (BCVA) of the studied eye from baseline	At Week 52

Contacts

Primary ContactXinyan Li

Xinyan.li@fronteratherapeutics.com+86-021-58206061

Backup ContactMinghui Xue

minghui.xue@fronteratherapeutics.com+86-021-58206061

Outcome results

None listed

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