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NCT Number: NCT06492876

Gene Therapy for DME

The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of disposable vitreous injection of FT-003 in subjects with Diabetic Macular Edema (DME). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.

Recruiting

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Key information

Conditions

Diabetic Macular Edema

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

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 18-74 years old at the time of signing the ICF;
  • Clinically diagnosed with CI-DME;
  • The best corrected visual acuity (BCVA) of the studied eye is 24-73 letters;

Exclusion criteria

  • Presence of any other intraocular diseases other than 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

Administered via intraocular injection.

Primary outcomes

  1. Safety and tolerability after FT-003 injection

    Time frame: At Week 12

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

Secondary outcomes

  1. To evaluate the efficacy after FT-003 injection

    Time frame: At Week 24

    the BCVA /CST change from baseline

Study contacts

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

Mignhui Xue

CONTACT

[email protected]

+86-021-58206061

Xinyan Li

CONTACT

[email protected]

+86-021-58206061

Sponsors and collaborators

Lead sponsor

Frontera Therapeutics

Industry

Registry information

Official study title

A Dose-escalation and Dose-expanded Phase I/II Clinical Study to Evaluate the Safety, and Efficacy of FT-003 in Subjects With DME

Important dates

Study start
2023
Primary completion
2024
Study completion
2028
First posted
Jul 9, 2024
Registry last updated
Jul 9, 2024

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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