Gene Therapy for Diabetic Macular Edema
ConditionDiabetic Macular Edema
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorFrontera Therapeutics
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
FT-003
GeneticAdministration via intraocular injection
Treatment groups
18 Participants
are divided into 3 treatment groupsGroup A: FT003 Dose 1Experimental treatment 1 intervention
Group B: FT003 Dose 2Experimental treatment 1 intervention
Group C: FT003 Dose 3Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and tolerability after FT-003 injection
Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0)
Time frame
Whthin 52 weeks after administrationSecondary outcomes
1
Preliminary effectiveness after FT-003 injection
Changes in best-corrected visual acuity (BCVA) of the studied eye from baseline
Time frame
Whthin 52 weeks after administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Frontera Therapeutics
Lead sponsor
Tianjin Medical University Eye Hospital
Collaborator
Peking Union Medical College Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Source ClinicalTrials.gov