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 ]
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