A Phase III, Double-masked, Multicenter, Randomized, Sham Injection-controlled Study of the Efficacy and Safety of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema With Center Involvement Secondary to Diabetes Mellitus.

Trial Profile

A Phase III, Double-masked, Multicenter, Randomized, Sham Injection-controlled Study of the Efficacy and Safety of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema With Center Involvement Secondary to Diabetes Mellitus.

Completed
Phase of Trial: Phase III

Latest Information Update: 01 May 2017

At a glance

  • Drugs Ranibizumab (Primary)
  • Indications Diabetic macular oedema
  • Focus Registrational; Therapeutic Use
  • Acronyms RISE
  • Sponsors Genentech
  • Most Recent Events

    • 08 Aug 2014 Genentech has submitted a supplemental Biologics License Application (sBLA) for Lucentis to the FDA for the treatment of diabetic retinopathy, based on results of the RIDE and RISE trials, according to a media release.
    • 10 Aug 2012 Results from this trial supported US FDA approval of ranibizumab for the treatment of diabetic macular oedema.
    • 01 Apr 2012 Results published in Ophthalmology.
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