Phase 2 trial of RGX-314 in diabetic retinopathy underway
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The first patient has been dosed in a phase 2 trial evaluating the efficacy, safety and tolerability of suprachoroidal delivery of RGX-314 for the treatment of diabetic retinopathy, according to a Regenxbio press release.
ALTITUDE is a multicenter, open-label, randomized, controlled dose-escalation trial expected to enroll approximately 40 patients with diabetic retinopathy (DR). Patients will receive either RGX-314 via the SCS microinjector or observational control at a 3:1 ratio. Two doses levels of RGX-314, 2.5 × 1011 GC per eye and 5 × 1011 GC per eye, will be evaluated.
The primary study endpoint is the proportion of patients with improved DR severity at 48 weeks. Safety and development of DR-related ocular complications are other endpoints that will be evaluated.
“This is our second phase 2 trial using the in-office suprachoroidal delivery approach, which may allow physicians to treat patients with diseases like DR earlier in the disease course,” Steve Pakola, MD, chief medical officer of Regenxbio, said in the release. “We believe that one-time treatment with anti-VEGF gene therapy can have a meaningful impact for patients with DR, and we look forward to providing additional updates from this trial next year.”
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