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Rainbow Extension Study

NCT02640664 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2023-02-13

Study results available
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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)

Conditions

  • Retinopathy of Prematurity (ROP)

Interventions

DRUG

Ranibizumab

1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-16
Primary Completion
2022-04-21
Completion
2022-04-21

Countries

  • United States
  • Austria
  • 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

Study Locations

More Related Trials

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 NCT02640664 on ClinicalTrials.gov