Tianjin Medical University Eye Hospital
Tianjin, Tianjin,China, 300392, China
Location status: Recruiting
Location contact
Xiaorong Li, Professor
CONTACT
NCT Number: NCT06492863
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.
Interested in participating?
Request Info50 year–80 year
All sexes
Interventional
Phase 1 / Phase 2
Tianjin, Tianjin,China, 300392, China
Location status: Recruiting
Xiaorong Li, Professor
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered via intraocular injection.
Time frame: At Week 12
Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0)
Time frame: At Week 24
the BCVA and OCT change from baseline
Contact information is provided by the study sponsor or research team.
Minghui Xue
CONTACT
Xinyan Li
CONTACT
Frontera Therapeutics
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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