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Phase III Clinical Study of the Efficacy and Safety of 9MW0813 and Aflibercept (EYLEA®) in Patients With Diabetic Macular Edema (DME) in a Multicenter, Randomized, Double-blind, Parallel Active-controlled Study

Trial Profile

Phase III Clinical Study of the Efficacy and Safety of 9MW0813 and Aflibercept (EYLEA®) in Patients With Diabetic Macular Edema (DME) in a Multicenter, Randomized, Double-blind, Parallel Active-controlled Study

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 10 Nov 2025

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At a glance

  • Drugs Aflibercept (Primary) ; Aflibercept
  • Indications Diabetic macular oedema
  • Focus Therapeutic Use
  • Sponsors Mabwell (Shanghai) Bioscience

Most Recent Events

  • 20 Sep 2025 Accoridng to a Mabwell media release, New Drug Application for 9MW0813 injection has been accepted by the National Medical Products Administration (NMPA) for the treatment of diabetic macular edema (DME) and neovascular (wet) age-related macular degeneration (nAMD).
  • 13 Apr 2022 New trial record
  • 05 Apr 2022 Status changed from not yet recruiting to recruiting.

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