Trial Profile

A Randomized, Partially Masked, Controlled, Phase 2b/3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants With nAMD (ATMOSPHERE)

Status: Recruiting

Phase of Trial: Phase II/III

Latest Information Update: 03 Feb 2025

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At a glance

29 Jan 2025 Planned number of patients changed from 300 to 540.
13 Jan 2025 According to a Abbvie media release, the data evaluating the safety and efficacy of the subretinal delivery of ABBV-RGX-314 in patients with wet AMD are expected in 2026.
08 Nov 2023 According to a REGENXBIO media release, this trial expected to support global regulatory submissions with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in late 2025 through the first half of 2026.

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