Gene Therapy Tested for Diabetic Macular Edema Eye Swelling
Tests FT-003 gene therapy, injected into the eye, in adults with diabetic macular edema.
Plain-language title generated from the registry record
Registry title: Gene Therapy for DME
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 74 years old?
Source: NCT06492876, who can take part
Where in China
- Tianjin Medical University Eye HospitalTianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Frontera Therapeutics
- Trial code
- NCT06492876
- Record updated
- 9 July 2024
- Original description
The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of disposable vitreous injection of FT-003 in subjects with Diabetic Macular Edema (DME). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.Read full original descriptionShow less
A Dose-escalation and Dose-expanded Phase I/II Clinical Study to Evaluate the Safety, and Efficacy of FT-003 in Subjects With DME
The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of disposable vitreous injection of FT-003 in subjects with Diabetic Macular Edema (DME). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.
Inclusion: Subjects that are willing and able to follow study procedures; Female or male patients 18-74 years old at the time of signing the ICF; Clinically diagnosed with CI-DME; The best corrected visual acuity (BCVA) of the studied eye is 24-73 letters.
Exclusion: Presence of any other intraocular diseases other than DME 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.