Gene Therapy for Wet AMD

Phase 1Not Yet RecruitingNCT05611424

Frontera Therapeutics18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neovascular Age-related Macular Degeneration

Interventions

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects that are willing and able to follow study procedures; * Female or male patients ≥45 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 ≤ 53 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.

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: At Week 52

Secondary Outcomes

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