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RAINBOW Study: a Randomized, Controlled Study Evaluating the Efficacy and Safety of RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity

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Trial Profile

RAINBOW Study: a Randomized, Controlled Study Evaluating the Efficacy and Safety of RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Ranibizumab (Primary)
  • Indications Retinopathy of prematurity
  • Focus Registrational; Therapeutic Use
  • Acronyms RAINBOW
  • Sponsors Novartis; Novartis Pharma KK; Novartis Pharmaceuticals

Most Recent Events

  • 22 Nov 2019 According to a Novartis media release, the Committee for Medicinal Products for Human Use, CHMP of the European Medicines Agency has approved Lucentis (ranibizumab 10 mg/ml) for the treatment of preterm infants with retinopathy of prematurity.
  • 16 Sep 2019 Results published in the Lancet.
  • 26 Jul 2019 According to a Novartis media release, the Committee for Medicinal Products for Human Use, CHMP of the European Medicines Agency has recommended approval of Lucentis (ranibizumab 10 mg/ml) for the treatment of preterm infants with retinopathy of prematurity. The European Commission will review the CHMP opinion and is expected to deliver its final decision within three months.

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