Gene Therapy(FT-003) for Wet AMD

Frontera Therapeutics

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Genetic: FT-003

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06492863

FT003-C101

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 neovascular age-related Macular Degeneration (nAMD). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.

Full description

FT-003 is a gene therapy product developed for the treatment of neovascular age-related macular degeneration (nAMD). Neovascular AMD is the main cause of blindness among elderly individuals. The available therapies for treating nAMD require life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. Administration of FT-003 has the potential to treat nAMD by providing durable expression of therapeutic levels of intraocular protein and maintaining the vision of patients. FT-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.

Enrollment: 78 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects that are willing and able to follow study procedures;
• Female or male patients 50-80 years old at the time of signing the ICF;
• Clinically diagnosed with nAMD;
• Presence of active CNV
• The best corrected visual acuity (BCVA) of the studied eye is 24-73 letters;

Exclusion criteria

• •Presence of any other intraocular diseases other than nAMD 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