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A Phase 3 Multicenter, Randomized, Double-Masked Study Comparing the Efficacy and Safety of Emixustat Hydrochloride With Placebo for the Treatment of Macular Atrophy Secondary to Stargardt Disease

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Trial Profile

A Phase 3 Multicenter, Randomized, Double-Masked Study Comparing the Efficacy and Safety of Emixustat Hydrochloride With Placebo for the Treatment of Macular Atrophy Secondary to Stargardt Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Jun 2024

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At a glance

  • Drugs Emixustat (Primary)
  • Indications Stargardt disease
  • Focus Registrational; Therapeutic Use
  • Acronyms SeaSTAR
  • Sponsors Kubota Vision

Most Recent Events

  • 03 Oct 2022 Primary endpoint (Mean rate of change in total area of macular atrophy, as measured by fundus autofluorescence (FAF)) has not been met as per Kubota Vision Media Release
  • 03 Oct 2022 Results of post hoc analysis of this trial published in the Kubota Vision Media Release
  • 27 Jul 2022 According to a Kubota Vision media release, the company announces completion of data entry, confirmation of the accuracy and completeness of the database, and final sign-off by all investigators in this trial. Now that the database is locked, the datasets are being transferred to an independent statistical group, who will unmask patient treatment and analyze the data. Top-line results from this study will be reported by in August 2022.

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