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NCT Number: NCT05916391

Gene Therapy for Diabetic Macular Edema

FT-003 is a gene therapy product developed for the treatment of central involvement diabetic macular edema (CI-DME). Diabetic retinopathy is one of the most common microvascular complications of diabetes mellitus, and diabetic macular edema is the main cause of vision loss in patients with diabetic retinopathy. In the latest guidelines, anti-VEGF therapy is preferred for CI-DME. Administration of FT-003 has the potential to treat CI-DME by providing intraocular protein which is durable expressed in therapeutic level. FT-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with CI-DME receiving anti-VEGF therapy in clinical practice.

Recruiting

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Key information

Conditions

Diabetic Macular Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tianjin Medical University Eye Hospital

Tianjin, Tianjin,China, 300392, China

Location status: Recruiting

Location contact

Xiaorong Li, Professor

CONTACT

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 ≥18 years old at the time of signing the ICF;
  • Clinically diagnosed with CI-DME
  • HbA1c≤10%
  • The best corrected visual acuity (BCVA) of the studied eye is ≤ 73 letters

Exclusion criteria

  • Presence of any other intraocular diseases other than CI-DME 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

Administration via intraocular injection

Primary outcomes

  1. Safety and tolerability after FT-003 injection

    Time frame: Whthin 52 weeks after administration

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

Secondary outcomes

  1. Preliminary effectiveness after FT-003 injection

    Time frame: Whthin 52 weeks after administration

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

Study contacts

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

Minghui Xue

CONTACT

[email protected]

+862158206061

Xinyan Li

CONTACT

[email protected]

+862158206061

Sponsors and collaborators

Lead sponsor

Frontera Therapeutics

Industry

Collaborators

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

Registry information

Official study title

An Open-label, Multy-center, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FT-003 in Subjects With Diabetic Macular Edema

Important dates

Study start
2023
Primary completion
2025
Study completion
2028
First posted
Jun 23, 2023
Registry last updated
Jun 23, 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.

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