Phase 2 Trial of RGX-314 in Adults With Center Involved - Diabetic Macular Edema (CI - DME)
Recruiting
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
- 25 – 89
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 18 (estimated)
- Sponsor
- Sierra Eye Associates · Other
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About This Trial
Phase 2 open label, randomized, active controlled, dose-ranging trial in adults with Center Involved - Diabetic Macular Edema (CI - DME)
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Type I or Type II diabetes mellitus with center involving diabetic macular edema with previous treatment
* HbA1c ≤12%
* BCVA in study eye 78 to 25 ETDRS letters (\~20/32 to 20/320) at screening
* Decreased visual acuity attributable primarily due to CI - DME
* Demonstrate clin…
Contacts