Diabetic retinopathy therapy trial.
A potential one-time gene therapy, RGX-314 is currently being developed to treat wet age-related macular degeneration, as well as various other chronic retinal ailments.
The multicentre, randomized, open-label, controlled dose-escalation Phase II trial is analyzing the efficacy, safety and tolerability of an in-office suprachoroidal delivery of RGX-314 given with the help of SCS Microinjector in DR patients.
Subjects included in the trial comprised people with moderately severe or severe non-proliferative diabetic retinopathy (NPDR) or mild proliferative diabetic retinopathy (PDR).
Findings showed that RGX-314 was demonstrated to be well tolerated in the 15 subjects dosed with RGX-314 in cohort 1.
A patient receiving RGX-314 experienced a serious adverse event, which happened in the untreated fellow eye and is deemed unrelated to the treatment.
No intraocular inflammation was reported on slit-lamp examination in subjects in Cohort 1 receiving RGX-314.