NCT05611424

Gene Therapy for Wet AMD

An Open-label, Single-center, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FT-003 in Subjects With Neovascular Age-related Macular Degeneration

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Frontera Therapeutics · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neovascular Age-related Macular Degeneration

Interventions

Type	Name	Description
GENETIC	FT-003	Administered via intraocular injection.

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-11-30
• Completion: 2027-12-30
• First posted: 2022-11-10
• Last updated: 2023-04-26