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
Price :
$35
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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
- 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.