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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 )

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

Condition or disease Intervention/treatment Phase
Retinopathy of Prematurity Drug: Ranibizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 16, 2016
Estimated Primary Completion Date : October 30, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: Ranibizumab 0.1 mg
Ranibizumab 0.1 mg
Drug: Ranibizumab
0.1 mg Intravitreal administration Up to 2 re-treatments in each eye 28 days minimum interval between 2 injections

Experimental: Ranibizumab 0.2 mg
Ranibizumab 0.2 mg
Drug: Ranibizumab
0.2 mg Intravitreal administration Up to 2 re-treatments in each eye 28 days minimum interval between 2 injections

No Intervention: Laser therapy
Laser therapy



Primary Outcome Measures :
  1. Visual function [ Time Frame: at the patient's fifth birthday ]
    Visual acuity in the better-seeing eye


Secondary Outcome Measures :
  1. Number of patients having any ocular Adverse Event [ Time Frame: at the patient's fifth birthday ]
  2. Number of patients having any systemic Adverse Event [ Time Frame: at the patient's fifth birthday ]
  3. Visual function [ Time Frame: at the patient's fifth birthday ]
    Visual acuity in the worse-seeing eye

  4. Absence of active Retinopathy of Prematurity (ROP) [ Time Frame: 40 weeks and 52 weeks after initial study treatment ]
  5. Absence of ocular structural abnormalities [ Time Frame: 40 weeks after initial study treatment, at the patient's 2 years corrected age and fifth birthday ]
  6. Recurrence of ROP [ Time Frame: 40 weeks and 52 weeks after initial study treatment ]
  7. Number of ranibizumab administrations [ Time Frame: 40 weeks after initial study treatment ]
  8. Refraction in each eye [ Time Frame: at the patient's 2 years' corrected age and fifth birthday ]
  9. Standing/sitting height and leg length [ Time Frame: at the patient's 2 years' corrected age and fifth birthday ]
  10. Weight [ Time Frame: at the patient's 2 years' corrected age and fifth birthday ]
  11. Head circumference [ Time Frame: at the patient's 2 years' corrected age ]
  12. Respiratory function [ Time Frame: at the patient's 2 years' corrected age and fifth birthday ]
    Percentage of patients with oxygen supplementation

  13. Hearing function [ Time Frame: at the patient's 2 years' corrected age and fifth birthday ]
    Percentage of patients with presence of hearing impairment

  14. Duration of hospitalization [ Time Frame: at the patient's 2 years' corrected age and fifth birthday ]
  15. Weight at first hospital discharge [ Time Frame: at the patient's 2 years' corrected age and fifth birthday ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02640664


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

  Show 74 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02640664     History of Changes
Other Study ID Numbers: CRFB002H2301E1
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
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


Keywords provided by Novartis ( Novartis Pharmaceuticals ):
open-label, long-term, extension study
intravitreal ranibizumab
laser ablation therapy
retinopathy of prematurity
preterm infants
RAINBOW

Additional relevant MeSH terms:
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Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents