Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05611424

Gene Therapy for Wet AMD

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Neovascular Age-related Macular Degeneration

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FT-003

Genetic

Administered via intraocular injection.

Primary outcomes

  1. Safety and tolerability after FT-003 injection

    Time frame: At Week 52

    Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0)

Secondary outcomes

  1. Changes in best-corrected visual acuity (BCVA) of the studied eye from baseline

    Time frame: At Week 52

Study contacts

Contact information is provided by the study sponsor or research team.

Minghui Xue

CONTACT

[email protected]

+86-021-58206061

Xinyan Li

CONTACT

[email protected]

+86-021-58206061

Sponsors and collaborators

Lead sponsor

Frontera Therapeutics

Industry

Collaborators

  • Peking Union Medical College Hospital
  • The First Affiliated Hospital of Soochow University
  • The First Affiliated Hospital of Zhengzhou University
  • Tianjin Medical University Eye Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2027
First posted
Nov 10, 2022
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.