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A Dose-escalation and Dose-expanded Phase I/II Clinical Study to Evaluate the Safety, and Efficacy of FT-003 in Subjects With Wet AMD
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.
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.
Age
50 - 80 years
Sex
ALL
Healthy Volunteers
No
Tianjin Medical University Eye Hospital
Tianjin, Tianjin,China, China
Start Date
August 15, 2023
Primary Completion Date
October 15, 2024
Completion Date
October 15, 2028
Last Updated
July 9, 2024
78
ESTIMATED participants
FT-003
GENETIC
Lead Sponsor
Frontera Therapeutics
Collaborators
NCT05562947
NCT05904028
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06213038