Gene Therapy for Wet AMD

Phase 1

Not yet recruiting

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

• Registration Number: NCT05611424
• Lead Sponsor: Frontera Therapeutics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-11-09
• Study First Posted: 2022-11-10
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-26
• Study Start: 2023-05-01
• Primary Completion: 2024-11-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Safety and tolerability after FT-003 injection	At Week 52	Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0)

Secondary Outcome Measures

Name	Time	Method
Changes in best-corrected visual acuity (BCVA) of the studied eye from baseline	At Week 52