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A Two-Year, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab versus Aflibercept in Adult Patients with Visual Impairment due to Diabetic Macular Edema (KITE)

Trial Profile

A Two-Year, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab versus Aflibercept in Adult Patients with Visual Impairment due to Diabetic Macular Edema (KITE)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Jan 2025

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At a glance

  • Drugs Brolucizumab (Primary) ; Aflibercept
  • Indications Diabetic macular oedema
  • Focus Registrational; Therapeutic Use
  • Acronyms KITE
  • Sponsors Novartis; Novartis Healthcare; Novartis Pharmaceuticals
  • Most Recent Events

    • 09 Nov 2022 Results assessing the safety and efficacy of brolucizumab 6mg vs aflibercept 2mg in diabetic macular edema presented at the 25th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research
    • 20 Jun 2022 Results published in the Novartis Media Release
    • 20 Jun 2022 According to a Novartis media release, based on year one data from the Phase III KESTREL and KITE studies, the European Commission (EC) has approved Beovu (brolucizumab) 120 mg / mL for the treatment of visual impairment due to diabetic macular edema (DME).

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