About this trial
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.
Eligibility criteria
Qualifiers
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%
Disqualifiers
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
Trial design
Treatments tested in this trial
- FT-003
Treatment groups
Sponsors and collaborators
Frontera Therapeutics
Lead sponsor
Tianjin Medical University Eye Hospital
Collaborator
Peking Union Medical College Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator