Gene Therapy for DME
Recruiting
Phase 1
Phase 2
Interventional Study
Diabetic Macular Edema
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 74
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 78 (estimated)
- Sponsor
- Frontera Therapeutics · Industry
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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.
Trial Locations
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Eligibility Criteria
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:
* P…
Contacts