Gene Therapy(FT-003) for Wet AMD

Plain-language summary

This Phase 1/2 trial evaluates FT-003 gene therapy in people with neovascular age-related macular degeneration (nAMD). The treatment is given as a single intravitreal injection, with a Phase 1 dose-escalation part followed by a Phase 2 dose-expansion part. Eligible participants are 50 to 80 years old with clinically diagnosed nAMD, active choroidal neovascularization (CNV), and best corrected visual acuity (BCVA) of 24 to 73 letters in the study eye.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

PHASE1/PHASE2

Status

Recruiting

Sponsor

Frontera Therapeutics

Intervention

FT-003

Start date

8/15/2023

Estimated completion

10/15/2028

Countries

China

Related genes

Locations

• Tianjin, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.