At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 224 enrolled
Drug / intervention
Ranibizumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Ranibizumab and Laser therapy for Retinopathy of Prematurity. Completed, enrolled 224 participants across 86 sites in 26 countries.
Detailed Summary
The purpose of this study was to determine if intravitreal ranibizumab is superior to laser ablation therapy in the treatment of retinopathy of prematurity (ROP).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRetinopathy of Prematurity
CountriesAustria, Belgium, Croatia, Czechia, Denmark, Egypt, Estonia, France, Germany, Greece, Hungary, India, Italy, Japan, Lithuania, Malaysia, Mexico, Poland, Romania, Russia, Saudi Arabia, Slovakia, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 2015
Enrollment StartDec 2015
Primary CompletionDec 2017
TodayJul 2026
First PostedMar 3, 2015
Enrollment StartDec 30, 2015
Primary CompletionDec 14, 2017
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 11.3 years ago
Interventions
Ranibizumabdrug
Administered as an intravitreal injection
Laser therapyprocedure
Transpupillary diode or frequency-doubled yttrium aluminum garnet (YAG) laser ablative therapy, following anesthesia or sedation