Gene Therapy for Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05916391
• Other study ID #: FT003DM-1
• Status: Recruiting
• Phase: Phase 1
• Start date: May 19, 2023
• Est. completion date: May 1, 2028

Study information

• Verified date: April 2023
• Source: Frontera Therapeutics
• Contact: Xinyan Li
• Phone: +862158206061
• Email: Xinyan.li[@]fronteratherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: May 1, 2028
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Genetic:
• FT-003
Administration via intraocular injection

Locations

Country	Name	City	State
China	Tianjin Medical University Eye Hospital	Tianjin	Tianjin,China

Sponsors (4)

Lead Sponsor	Collaborator
Frontera Therapeutics	Peking Union Medical College Hospital, The First Affiliated Hospital of Zhengzhou University, Tianjin Medical University Eye Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability after FT-003 injection	Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0)	Whthin 52 weeks after administration
Secondary	Preliminary effectiveness after FT-003 injection	Changes in best-corrected visual acuity (BCVA) of the studied eye from baseline	Whthin 52 weeks after administration