Gene Therapy Tested for Diabetic Macular Edema in Adults
Tests gene therapy FT-003 in adults with swelling in the central retina from diabetes.
Plain-language title generated from the registry record
Registry title: Gene Therapy for Diabetic Macular Edema
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 1
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
- NCT05916391
- Record updated
- 23 June 2023
- Original description
FT-003 is a gene therapy product developed for the treatment of central involvement diabetic macular edema (CI-DME). Diabetic retinopathy is one of the most common microvascular complications of diabetes mellitus, and diabetic macular edema is the main cause of vision loss in patients with diabetic retinopathy. In the latest guidelines, anti-VEGF therapy is preferred for CI-DME. Administration of FT-003 has the potential to treat CI-DME by providing intraocular protein which is durable expressed in therapeutic level. FT-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with CI-DME receiving anti-VEGF therapy in clinical practice.Read full original descriptionShow less
An Open-label, Multy-center, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FT-003 in Subjects With Diabetic Macular Edema
FT-003 is a gene therapy product developed for the treatment of central involvement diabetic macular edema (CI-DME). Diabetic retinopathy is one of the most common microvascular complications of diabetes mellitus, and diabetic macular edema is the main cause of vision loss in patients with diabetic retinopathy. In the latest guidelines, anti-VEGF therapy is preferred for CI-DME. Administration of FT-003 has the potential to treat CI-DME by providing intraocular protein which is durable expressed in therapeutic level. FT-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with CI-DME receiving anti-VEGF therapy in clinical practice.
Inclusion: Subjects that are willing and able to follow study procedures; Female or male patients ≥18 years old at the time of signing the ICF; Clinically diagnosed with CI-DME; HbA1c≤10%; The best corrected visual acuity (BCVA) of the studied eye is ≤ 73 letters.
Exclusion: Presence of any other intraocular diseases other than CI-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.