Gene Therapy for Diabetic Macular Edema

NCT05916391 · tracked via the Priya Life Science China tracker

Sponsor

Frontera Therapeutics

Phase

Phase 1

Started

2023-05-19

Last updated

2023-06-23

Condition(s) studied

Diabetic Macular Edema

Investigational drug(s) / intervention(s)

FT-003

FT-003: Administration via intraocular injection

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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

Primary outcome measure(s)

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)

Trial sites (1)

Facility	City	Region	Status
Tianjin Medical University Eye Hospital	Tianjin	Tianjin,China	Recruiting

More Frontera Therapeutics trials in China

Gene Therapy in Subjects With Biallelic RPE65 Mutation-associated Retinal Dystrophy Recruiting

Gene Therapy(FT-003) for Wet AMD Recruiting

Gene Therapy for Subjects With RPGR Mutation-associated X-linked Retinitis Pigmentosa Recruiting

Gene Therapy for DME Recruiting

Other trials for the same condition

Brolucizumab Efficacy and Safety Single-Arm Descriptive Trial in Patients With Persistent Diabetic Macular Edema Active, not recruiting

Exploring the Interaction Between Metabolic Disorders and NLPR3 Inflammasome Activation in DR Inflammatory Damage Starting soon

A Real-world Study to Assess Safety of OZURDEX® (Dexamethasone Intravitreal Implant) in Adult Participants With Diabetic Macular Edema in China Active, not recruiting

Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study) Active, not recruiting

Efficacy and Safety of Conbercept for Diabetic Macular Edema Combined With Severe Non-proliferative Diabetic Retinopathy Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05916391 on ClinicalTrials.gov ↗ ← All trials in China