Trials / Completed
CompletedNCT02375971
RAINBOW Study: RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity
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
- Phase 3
- Study type
- Interventional
- Enrollment
- 224 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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).
Detailed description
The study consisted of a screening period (screening and randomization could occur up to 3 days before the administration of the first investigational treatment), followed by a treatment and follow-up period (Day 1 to Day 169).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ranibizumab | Administered as an intravitreal injection |
| PROCEDURE | Laser therapy | Transpupillary diode or frequency-doubled yttrium aluminum garnet (YAG) laser ablative therapy, following anesthesia or sedation |
Timeline
- Start date
- 2015-12-30
- Primary completion
- 2017-12-14
- Completion
- 2017-12-14
- First posted
- 2015-03-03
- Last updated
- 2018-11-14
- Results posted
- 2018-07-31
Locations
86 sites across 26 countries: United States, Austria, 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
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02375971. Inclusion in this directory is not an endorsement.