Gene Therapy for Diabetic Macular Edema

Phase 1RecruitingNCT05916391

Frontera Therapeutics18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Macular Edema

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Safety and tolerability after FT-003 injection

Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0)

Time frame: Whthin 52 weeks after administration

Secondary Outcomes

Preliminary effectiveness after FT-003 injection

Changes in best-corrected visual acuity (BCVA) of the studied eye from baseline