NCT06492863 Gene Therapy(FT-003) for Wet AMD
| NCT ID | NCT06492863 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Frontera Therapeutics |
| Condition | Neovascular Age-related Macular Degeneration |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2023-08-15 |
| Primary Completion | 2024-10-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 78 participants in total. It began in 2023-08-15 with a primary completion date of 2024-10-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Subjects that are willing and able to follow study procedures; * Female or male patients 50-80 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 24-73 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.
Contact & Investigator
Xiaorong Li, Professor
PRINCIPAL INVESTIGATOR
Tianjin Medical University Eye Hospital
Frequently Asked Questions
Who can join the NCT06492863 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Neovascular Age-related Macular Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06492863 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06492863 currently recruiting?
Yes, NCT06492863 is actively recruiting participants. Contact the research team at xinyan.li@fronteratherapeutics.com for enrollment information.
Where is the NCT06492863 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06492863 clinical trial?
NCT06492863 is sponsored by Frontera Therapeutics. The principal investigator is Xiaorong Li, Professor at Tianjin Medical University Eye Hospital. The trial plans to enroll 78 participants.