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

NCT02375971 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2018-11-14

Study results available
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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).

Conditions

  • Retinopathy of Prematurity

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-30
Primary Completion
2017-12-14
Completion
2017-12-14
FDA Drug
Yes

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

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02375971 on ClinicalTrials.gov