Ignite Creation Date:
2024-07-17 @ 11:01 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492863
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-01
Brief Title:
Gene TherapyFT-003 for Wet AMD
Sponsor:
Frontera Therapeutics
Organization:
Frontera Therapeutics
Study Overview
Official Title:
A Dose-escalation and Dose-expanded Phase III Clinical Study to Evaluate the Safety and Efficacy of FT-003 in Subjects With Wet AMD
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None