Gene Therapy for DME

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

Study Overview

• Status: Recruiting
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Genetic: FT-003

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Xinyan Li; Phone Number: +86-021-58206061; Email: xinyan.li@fronteratherapeutics.com
• Study Contact Backup: Name: Mignhui Xue; Phone Number: +86-021-58206061; Email: minghui.xue@fronteratherapeutics.com

Study Locations

• China
  • Tianjin,China
    • Tianjin, Tianjin,China, China, 300392
      • Recruiting
      • Tianjin Medical University Eye Hospital
      • Contact: Xiaorong Li, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FT003 Dose 1; Low dose of FT-003	Genetic: FT-003; Administered via intraocular injection.
Experimental: FT003 Dose 2; Mid dose of FT-003	Genetic: FT-003; Administered via intraocular injection.
Experimental: FT003 Dose 3; High dose of FT-003	Genetic: FT-003; Administered via intraocular injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability after FT-003 injection	Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0)	At Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the efficacy after FT-003 injection	the BCVA /CST change from baseline	At Week 24

Collaborators and Investigators

• Sponsor: Frontera Therapeutics
• Investigators: Principal Investigator: Xiaorong Li, professor, Tianjin Medical University Eye Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): November 15, 2024
• Study Completion (Estimated): November 15, 2028

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Diabetic Macular Edema; FT-003
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema
• Other Study ID Numbers: FT003-CD101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No