Gene therapy for wet age-related macular degeneration
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
This study is testing a new gene therapy to see if it can help people with wet age-related macular degeneration keep their vision and reduce the need for frequent treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Frontera Therapeutics Industry-sponsored |
| Locations | 1 site (Tianjin, Tianjin,China) |
| Trial ID | NCT06492863 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety, tolerability, and efficacy of FT-003, a gene therapy product, for treating neovascular age-related macular degeneration (nAMD). The study is divided into two phases: a Phase 1 dose escalation to determine the appropriate dosage and a Phase 2 dose expansion to further assess its effectiveness. FT-003 aims to provide a durable expression of therapeutic proteins to reduce the treatment burden associated with current therapies, which require frequent injections. By potentially maintaining vision in patients, this approach addresses a significant unmet need in the management of nAMD.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 50-80 years who have been clinically diagnosed with active neovascular age-related macular degeneration.
Not a fit: Patients with other intraocular diseases that could affect visual acuity improvement will not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly reduce the frequency of treatments required for patients with nAMD, potentially preserving their vision more effectively.
How similar studies have performed: Other studies have shown promise with gene therapy approaches for retinal diseases, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tianjin, Tianjin,China
- Tianjin Medical University Eye Hospital — Tianjin, Tianjin,China, China (Recruiting)
Study contacts
- Principal investigator: Xiaorong Li, Professor — Tianjin Medical University Eye Hospital
- Study coordinator: Xinyan Li
- Email: xinyan.li@fronteratherapeutics.com
- Phone: 86-021-58206061
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.