Clinical Trial: RAINBOW Study: RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Ret

Brief Summary: The purpose of this study is to determine if intravitreal ranibizumab is superior to laser ablation therapy in the treatment of retinopathy of prematurity (ROP).

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Absence of active Retinopathy of Prematurity (ROP) and unfavorable structural outcome [ Time Frame: 24 weeks after starting investigational treatment ]

To achieve this outcome, patients must fulfill all the following criteria, 1) survival, 2) no intervention with a second modality for ROP, 3) absence of active ROP and 4) absence of unfavorable structural outcome


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Requirement for intervention with a second modality for ROP [ Time Frame: 24 weeks after starting investigational treatment ]
  • Time to intervention with a second modality for ROP or development of unfavorable structural outcome or death [ Time Frame: 24 weeks after starting investigational treatment ]
  • Recurrence of ROP [ Time Frame: 24 weeks after starting investigational treatment ]
  • Number of patients having any ocular Adverse Event [ Time Frame: 24 weeks after starting investigational treatment ]
  • Systemic ranibizumab levels [ Time Frame: Within 24 hours, 14 days and 28 days after ranibizumab treatment ]
  • Systemic Vascular Endothelial Growth Factor (VEGF) levels [ Time Frame: Before investigational treatment, 14 days and 28 days after investigational treatment ]
  • Number of ranibizumab administrations [ Time Frame: 24 weeks after starting investigational treatment ]
  • Number of patients having any systemic Adverse Event [ Time Frame: 24 weeks after starting investigational treatment ]


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: February 18, 2015
Date Started: December 30, 2015
Date Completion: December 31, 2017
Last Updated: March 22, 2017
Last Verified: March 2017