Gene Therapy for DME

Frontera Therapeutics

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Diabetic Macular Edema

Treatments: Genetic: FT-003

Study type: Interventional

Funder types: Industry

Identifiers

NCT06492876

FT003-CD101

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of disposable vitreous injection of FT-003 in subjects with Diabetic Macular Edema (DME). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects that are willing and able to follow study procedures;
• Female or male patients 18-74 years old at the time of signing the ICF;
• Clinically diagnosed with CI-DME;
• The best corrected visual acuity (BCVA) of the studied eye is 24-73 letters;

Exclusion criteria

• Presence of any other intraocular diseases other than 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: Sequential Assignment

Masking: None (Open label)

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78 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