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A 12-month, Randomized, Double-masked, Multicenter, Laser-controlled Phase III Study Assessing the Efficacy and Safety of 0.5 mg Ranibizumab Dosed PRN in Subjects With Visual Impairment Due to Diabetic Macular Edema in Chinese Patients

Trial Profile

A 12-month, Randomized, Double-masked, Multicenter, Laser-controlled Phase III Study Assessing the Efficacy and Safety of 0.5 mg Ranibizumab Dosed PRN in Subjects With Visual Impairment Due to Diabetic Macular Edema in Chinese Patients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Mar 2019

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At a glance

  • Drugs Ranibizumab (Primary)
  • Indications Diabetic macular oedema; Vision disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms REFINE
  • Sponsors Novartis Pharmaceuticals
  • Most Recent Events

    • 01 Mar 2019 Primary endpoint (Mean Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) (Letters) to Month 1 Through 12) has been met as per results published in the Graefes Archive for Clinical and Experimental Ophthalmology
    • 01 Mar 2019 Results published in the Graefes Archive for Clinical and Experimental Ophthalmology
    • 29 Mar 2017 Status changed from active, no longer recruiting to completed.
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