Gene Therapy for Diabetic Macular Edema

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05916391

Enrollment

Registered

2023-06-23

Start date

2023-05-19

Completion date

2028-05-01

Last updated

2023-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema

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.

Interventions

GENETICFT-003

Administration via intraocular injection

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Central Involvement Diabetic Macular Edema

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

China

Contacts

Primary ContactXinyan Li

Xinyan.li@fronteratherapeutics.com+862158206061

Backup ContactMinghui Xue

minghui.xue@fronteratherapeutics.com+862158206061

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026