At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 180 enrolled
Drug / intervention
Ranibizumabdrug
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 Extension Study: an Extension Study to Evaluate the Long Term 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 for Retinopathy of Prematurity (ROP). Completed, enrolled 180 participants across 73 sites in 24 countries.
Detailed Summary
The purpose of this study was to evaluate the long term efficacy and safety of intravitreal ranibizumab compared with laser ablation therapy in patients who were treated for retinopathy of prematurity (ROP) in the core study CRFB002H2301 (NCT02375971)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRetinopathy of Prematurity (ROP)
CountriesAustria, Belgium, Croatia, Czechia, Denmark, Egypt, Estonia, France, Germany, Greece, Hungary, India, Italy, Japan, Lithuania, Malaysia, Romania, Russia, Saudi Arabia, Slovakia, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 2015
Enrollment StartJun 2016
Primary CompletionApr 2022
TodayJul 2026
First PostedDec 29, 2015
Enrollment StartJun 16, 2016
Primary CompletionApr 21, 2022
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 10.5 years ago
Interventions
Ranibizumabdrug
1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required