Clinical Trials – Diabetic retinopathy therapy trial.

RGX-314 was found to be well tolerated in Cohort 1 subjects, with no drug-related serious adverse event reported.
Diabetic retinopathy

Diabetic retinopathy therapy trial.

Regenxbio has reported preliminary results from the ongoing Phase II ALTITUDE clinical trial of RGX-314 to treat diabetic retinopathy (DR) without centre-involved diabetic macular oedema (CI-DME).

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.

Diabetic retinopathy


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