A Randomized, Double-masked, Multi-center, Phase II Study Assessing the Safety and Efficacy of Two Concentrations of Ranibizumab (Intravitreal Injections) Compared With Non-treatment Control for the Treatment of Diabetic Macular Edema With Center Involvement.

Trial Profile

A Randomized, Double-masked, Multi-center, Phase II Study Assessing the Safety and Efficacy of Two Concentrations of Ranibizumab (Intravitreal Injections) Compared With Non-treatment Control for the Treatment of Diabetic Macular Edema With Center Involvement.

Completed
Phase of Trial: Phase II

Latest Information Update: 18 Feb 2015

At a glance

  • Drugs Ranibizumab (Primary)
  • Indications Diabetic macular oedema
  • Focus Therapeutic Use
  • Acronyms RESOLVE
  • Sponsors Novartis
  • Most Recent Events

    • 02 Nov 2012 Planned patient number is 150 according to European Clinical Trials Database record.
    • 07 Jan 2011 Based on results from this and the RESTORE trial the EU has approved ranibizumab [Lucentis] for the treatment of diabetic macular oedema, according to a Novartis media release.
    • 22 Oct 2010 CHMP positive opinion supports Lucentis approval in EU for treatment in patients with visual impairment due to diabetic macular oedema, based on data from this and the RESTORE (700034721) trial, according to a Novartis media release.
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