Gene Therapy for DME

Last updated: July 1, 2024
Sponsor: Frontera Therapeutics
Overall Status: Active - Recruiting

Phase

1/2

Condition

Diabetic Macular Edema

Macular Edema

Diabetic Retinopathy

Treatment

FT-003

Clinical Study ID

NCT06492876
FT003-CD101
  • Ages 18-74
  • All Genders

Study 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 Diabetic Macular Edema (DME). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Presence of any other intraocular diseases other than DME in the studied eye thatwould affect the improvement of visual acuity and require treatment during the studyfor prevention or treatment of visual loss, as judged by the investigator.

Study Design

Total Participants: 78
Treatment Group(s): 1
Primary Treatment: FT-003
Phase: 1/2
Study Start date:
November 15, 2023
Estimated Completion Date:
November 15, 2028

Connect with a study center

  • Tianjin Medical University Eye Hospital

    Tianjin, Tianjin,China 300392
    China

    Active - Recruiting

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