September 10, 2020
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Phase 2 trial of RGX-314 to treat wet AMD underway

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The first patient has been dosed in a phase 2 trial evaluating suprachoroidal delivery of RGX-314 to treat wet age-related macular degeneration, according to a Regenxbio press release.

AAVIATE is a multicenter, open-label, randomized, active-controlled, dose-escalation trial evaluating the efficacy, safety and tolerability of suprachoroidal delivery of RGX-314 using the SCS microinjector. About 40 patients with severe wet AMD will be randomly assigned 3:1 to receive RGX-314 vs. monthly 0.5 mg ranibizumab intravitreal injections, with two dose levels of RGX-314 evaluated, 2.5 × 1011 GC per eye and 5 × 1011 GC per eye. Prophylactic immune suppressive corticosteroid therapy will not be given before or after administration.

“The initiation of this trial is an important milestone for Regenxbio, as it is the first clinical trial to evaluate the delivery of any gene therapy, including RGX-314, to the suprachoroidal space,” Steve Pakola, MD, chief medical officer, Regenxbio, said in the release.

The study’s primary endpoint is the mean change in best corrected visual acuity at week 40 from baseline compared with monthly ranibizumab injections. Secondary endpoints include mean change in central retinal thickness and the number of anti-VEGF intravitreal injections given after RGX-314 administration.

Interim data are expected later this year.