Gene Therapy for DME
ConditionDiabetic Macular Edema
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-74
SponsorFrontera Therapeutics
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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.
Trial design
Treatments tested in this trial
- FT-003
Treatment groups
78 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov