Gene Therapy(FT-003) for Wet AMD

Phase 1

Recruiting

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Genetic: FT-003

• Registration Number: NCT06492863
• Lead Sponsor: Frontera Therapeutics

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2023-08-15
• Status Verified: 2024-07
• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-01
• Last Update Submitted: 2024-07-01
• Study First Posted: 2024-07-09
• Last Update Posted: 2024-07-09
• Primary Completion: 2024-10-15
• Study Completion: 2028-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
FT003 Dose 3	FT-003	High dose of FT-003
FT003 Dose 1	FT-003	Low dose of FT-003
FT003 Dose 2	FT-003	Mid dose of FT-003

Primary Outcome Measures

Name	Time	Method
Safety and tolerability after FT-003 injection	At Week 12	Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0)

Secondary Outcome Measures

Name	Time	Method
To evaluate the efficacy after FT-003 injection	At Week 24	the BCVA and OCT change from baseline

Trial Locations

Locations (1)

Tianjin Medical University Eye Hospital; 🇨🇳 Tianjin, Tianjin,China, China