Gene therapy for wet age-related macular degeneration

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.