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A Randomized, Double-masked, Photodynamic Therapy-controlled Phase-3 Study of the Efficacy, Safety, and Tolerability of Intravitreal VEGF Trap-Eye in Chinese Subjects With Neovascular Age-Related Macular Degeneration

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Trial Profile

A Randomized, Double-masked, Photodynamic Therapy-controlled Phase-3 Study of the Efficacy, Safety, and Tolerability of Intravitreal VEGF Trap-Eye in Chinese Subjects With Neovascular Age-Related Macular Degeneration

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 May 2018

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At a glance

  • Drugs Aflibercept (Primary)
  • Indications Choroidal neovascularisation; Wet age-related macular degeneration
  • Focus Registrational; Therapeutic Use
  • Acronyms SIGHT
  • Sponsors Bayer

Most Recent Events

  • 11 May 2018 Based on the data from SIGHT along with results from VIEW 1 and VIEW 2 studies, Eylea (aflibercept solution for injection into the eye) has been approved by the Chinese regulatory authorities for the treatment of visual impairment due to neovascular (wet) age-related macular degeneration (wAMD).
  • 01 Apr 2015 Primary endpoint 'Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 28 Last Observation Carried Forward (LOCF)' has been met, according to a Bayer media release.
  • 01 Apr 2015 According to Bayer media release, based on the 28-week results of the SIGHT study, as well as those of the previous VIEW 1(see profile 700238595) and VIEW 2 (see profile 700238599) trial, Bayer HealthCare has submitted an application for marketing authorization of aflibercept solution for injection for the treatment of patients with wet AMD to the China Food and Drug Administration.

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