Gene Therapy for Diabetic Macular Edema

Frontera Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Diabetic Macular Edema

Treatments: Genetic: FT-003

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05916391

FT003DM-1

Details and patient eligibility

About

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

FT003 Dose 1

Experimental group

Description:

Low dose of FT-003

Treatment:

Genetic: FT-003

FT003 Dose 2

Experimental group

Description:

Mid dose of FT-003

Treatment:

Genetic: FT-003

FT003 Dose 3

Experimental group

Description:

High dose of FT-003

Treatment:

Genetic: FT-003