Diabetic Macular Edema
Conditions
Keywords
Diabetic Macular Edema, FT-003
Brief summary
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.
Interventions
GENETICFT-003
Administered via intraocular injection.
Sponsors
Frontera Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability after FT-003 injection | At Week 12 | Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the efficacy after FT-003 injection | At Week 24 | the BCVA /CST change from baseline |
Countries
China
Contacts
Primary ContactXinyan Li
Backup ContactMignhui Xue
Outcome results
None listed