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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02375971
First Posted: March 3, 2015
Last Update Posted: October 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
The purpose of this study is to determine if intravitreal ranibizumab is superior to laser ablation therapy in the treatment of retinopathy of prematurity (ROP).

Condition Intervention Phase
Retinopathy of Prematurity Drug: Ranibizumab Procedure: Laser therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Absence of active Retinopathy of Prematurity (ROP) and unfavorable structural outcome [ Time Frame: 24 weeks after starting investigational treatment ]
    To achieve this outcome, patients must fulfill all the following criteria, 1) survival, 2) no intervention with a second modality for ROP, 3) absence of active ROP and 4) absence of unfavorable structural outcome


Secondary Outcome Measures:
  • Requirement for intervention with a second modality for ROP [ Time Frame: 24 weeks after starting investigational treatment ]
  • Time to intervention with a second modality for ROP or development of unfavorable structural outcome or death [ Time Frame: 24 weeks after starting investigational treatment ]
  • Recurrence of ROP [ Time Frame: 24 weeks after starting investigational treatment ]
  • Number of patients having any ocular Adverse Event [ Time Frame: 24 weeks after starting investigational treatment ]
  • Systemic ranibizumab levels [ Time Frame: Within 24 hours, 14 days and 28 days after ranibizumab treatment ]
  • Systemic Vascular Endothelial Growth Factor (VEGF) levels [ Time Frame: Before investigational treatment, 14 days and 28 days after investigational treatment ]
  • Number of ranibizumab administrations [ Time Frame: 24 weeks after starting investigational treatment ]
  • Number of patients having any systemic Adverse Event [ Time Frame: 24 weeks after starting investigational treatment ]

Enrollment: 224
Actual Study Start Date: December 30, 2015
Estimated Study Completion Date: December 19, 2017
Estimated Primary Completion Date: December 19, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranibizumab 0.2 mg Drug: Ranibizumab
0.2 mg Intravitreal administration Administration in both eyes on day 1 Up to 2 re-treatments in each eye 28 days minimum interval between 2 injections
Experimental: Ranibizumab 0.1 mg Drug: Ranibizumab
0.1 mg Intravitreal administration Administration in both eyes on day 1 Up to 2 re-treatments in each eye 28 days minimum interval between 2 injections
Active Comparator: Laser therapy Procedure: Laser therapy
Treatment in both eyes on day 1 Supplementary laser treatments are allowed until 11 days after first treatment

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Preterm infants with a birth weight of less than 1500 g
  • Bilateral ROP with 1 of the following retinal findings in each eye:

Zone I, stage 1+, 2+, 3 or 3+ disease, or Zone II, stage 3+ disease, or Aggressive posterior ROP

Exclusion Criteria:

  • Have received any previous surgical or nonsurgical treatment for ROP (e.g., ablative laser therapy or cryotherapy, vitrectomy)
  • Have been previously exposed to any intravitreal or systemic anti-VEGF agent (either the patient or the mother during this child's pregnancy)
  • Have ocular structural abnormalities that are assessed by the Investigator to have a clinically significant impact on study assessments
  • Have active ocular infection within 5 days before or on the day of first investigational treatment
  • Have any other medical conditions or clinically significant comorbidities or personal circumstances that are assessed by the Investigator to have a clinically relevant impact on study participation, any of the study procedures, or on efficacy assessments

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
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): NCT02375971


  Show 86 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02375971     History of Changes
Other Study ID Numbers: CRFB002H2301
First Submitted: February 18, 2015
First Posted: March 3, 2015
Last Update Posted: October 16, 2017
Last Verified: October 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
intravitreal ranibizumab
laser ablation therapy
retinopathy of prematurity
preterm infants
RAINBOW

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