Gene Therapy for Diabetic Macular Edema

Phase 1

Recruiting

• Conditions: Diabetic Macular Edema
• Interventions: Genetic: FT-003

• Registration Number: NCT05916391
• Lead Sponsor: Frontera Therapeutics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-04
• Study Start: 2023-05-19
• Study First Submitted: 2023-06-14
• Study First Submitted QC: 2023-06-14
• Last Update Submitted: 2023-06-14
• Study First Posted: 2023-06-23
• Last Update Posted: 2023-06-23
• Primary Completion: 2025-05-01
• Study Completion: 2028-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FT003 Dose 3	FT-003	High dose of FT-003
FT003 Dose 1	FT-003	Low dose of FT-003
FT003 Dose 2	FT-003	Mid dose of FT-003

Primary Outcome Measures

Name	Time	Method
Safety and tolerability after FT-003 injection	Whthin 52 weeks after administration	Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0)

Secondary Outcome Measures

Name	Time	Method
Preliminary effectiveness after FT-003 injection	Whthin 52 weeks after administration	Changes in best-corrected visual acuity (BCVA) of the studied eye from baseline

Trial Locations

Locations (1)

Tianjin Medical University Eye Hospital; 🇨🇳 Tianjin, Tianjin,China, China