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Rainbow Extension Study (RainbowExt)

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ClinicalTrials.gov Identifier: NCT02640664
Recruitment Status : Recruiting
First Posted : December 29, 2015
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE December 1, 2015
First Posted Date  ICMJE December 29, 2015
Last Update Posted Date October 3, 2018
Actual Study Start Date  ICMJE June 16, 2016
Estimated Primary Completion Date October 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2015)
Visual function [ Time Frame: at the patient's fifth birthday ]
Visual acuity in the better-seeing eye
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02640664 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2015)
  • Number of patients having any ocular Adverse Event [ Time Frame: at the patient's fifth birthday ]
  • Number of patients having any systemic Adverse Event [ Time Frame: at the patient's fifth birthday ]
  • Visual function [ Time Frame: at the patient's fifth birthday ]
    Visual acuity in the worse-seeing eye
  • Absence of active Retinopathy of Prematurity (ROP) [ Time Frame: 40 weeks and 52 weeks after initial study treatment ]
  • Absence of ocular structural abnormalities [ Time Frame: 40 weeks after initial study treatment, at the patient's 2 years corrected age and fifth birthday ]
  • Recurrence of ROP [ Time Frame: 40 weeks and 52 weeks after initial study treatment ]
  • Number of ranibizumab administrations [ Time Frame: 40 weeks after initial study treatment ]
  • Refraction in each eye [ Time Frame: at the patient's 2 years' corrected age and fifth birthday ]
  • Standing/sitting height and leg length [ Time Frame: at the patient's 2 years' corrected age and fifth birthday ]
  • Weight [ Time Frame: at the patient's 2 years' corrected age and fifth birthday ]
  • Head circumference [ Time Frame: at the patient's 2 years' corrected age ]
  • Respiratory function [ Time Frame: at the patient's 2 years' corrected age and fifth birthday ]
    Percentage of patients with oxygen supplementation
  • Hearing function [ Time Frame: at the patient's 2 years' corrected age and fifth birthday ]
    Percentage of patients with presence of hearing impairment
  • Duration of hospitalization [ Time Frame: at the patient's 2 years' corrected age and fifth birthday ]
  • Weight at first hospital discharge [ Time Frame: at the patient's 2 years' corrected age and fifth birthday ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rainbow Extension Study
Official Title  ICMJE 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
Brief Summary The purpose of this study is 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Retinopathy of Prematurity
Intervention  ICMJE
  • Drug: Ranibizumab
    0.2 mg Intravitreal administration Up to 2 re-treatments in each eye 28 days minimum interval between 2 injections
  • Drug: Ranibizumab
    0.1 mg Intravitreal administration Up to 2 re-treatments in each eye 28 days minimum interval between 2 injections
Study Arms  ICMJE
  • Experimental: Ranibizumab 0.1 mg
    Ranibizumab 0.1 mg
    Intervention: Drug: Ranibizumab
  • Experimental: Ranibizumab 0.2 mg
    Ranibizumab 0.2 mg
    Intervention: Drug: Ranibizumab
  • No Intervention: Laser therapy
    Laser therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 2, 2018)
224
Original Estimated Enrollment  ICMJE
 (submitted: December 23, 2015)
300
Estimated Study Completion Date  ICMJE October 31, 2022
Estimated Primary Completion Date October 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The patient successfully completed the core study CRFB002H2301
  • The patient received study treatment in both eyes at baseline of study CRFB002H2301

Exclusion Criteria:

  • Patient has a medical condition or personal circumstance which precludes study participation or compliance with study procedures, as assessed by the Investigator
  • Patient has been discontinued from the core study CRFB002H2301 at any time

Other protocol-defined inclusion/exclusion criteria may apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111
Listed Location Countries  ICMJE Austria,   Belgium,   Croatia,   Czechia,   Denmark,   Egypt,   Estonia,   France,   Germany,   Greece,   Hungary,   India,   Italy,   Japan,   Lithuania,   Malaysia,   Mexico,   Romania,   Russian Federation,   Saudi Arabia,   Slovakia,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02640664
Other Study ID Numbers  ICMJE CRFB002H2301E1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP