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Completed

NCT Number: NCT02375971

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

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).

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Key information

Conditions

Retinopathy of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Retinal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Graz, Austria

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About this study

The study consisted of a screening period (screening and randomization could occur up to 3 days before the administration of the first investigational treatment), followed by a treatment and follow-up period (Day 1 to Day 169).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • preterm infants with a birth weight of less than 1500 g
  • bilateral ROP with one 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 retinopathy of prematurity (AP-ROP)

Exclusion criteria

  • ROP disease characteristic in either eye other than that listed above at the time of the first investigational treatment
  • A history of hypersensitivity (either the patient or the mother) to any of the investigational treatments or to drugs of similar chemical classes
  • Had received any previous surgical or nonsurgical treatment for ROP (e.g., ablative laser therapy or cryotherapy, vitrectomy)
  • Had been previously exposed to any intravitreal or systemic anti-VEGF agent (either the patient or the mother during this child's pregnancy)
  • Had used (either the patient or the mother) other investigational drugs as part of another clinical study (other than vitamins and minerals) within 30 days or within 5 half-lives of the other investigational drug, whichever was longer
  • Had ocular structural abnormalities that were assessed by the Investigator to have had a clinically significant impact on study assessments
  • Had active ocular infection within 5 days before or on the day of first investigational treatment
  • Had a history of hydrocephalus requiring treatment
  • Had a history of any other neurological conditions that are assessed by the Investigator to have a significant risk of severe impact on visual function
  • Had any other medical conditions or clinically significant comorbidities or personal circumstances that were assessed by the Investigator to have a clinically relevant impact on study participation, any of the study procedures, or on efficacy assessments (e.g., poor life expectancy, pupil not able to be adequately dilated, unable to comply with the visit schedule)

Treatment and study plan

ranibizumab

Drug

Administered as an intravitreal injection

laser therapy

Procedure

Transpupillary diode or frequency-doubled yttrium aluminum garnet (YAG) laser ablative therapy, following anesthesia or sedation

Primary outcomes

  1. Percentage of Participants With Absence of Active ROP and Absence of Unfavorable Structural Outcomes in Both Eyes at Week 24

    Time frame: Week 24

    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. Retinopathy of prematurity (ROP) is a pathologic process that occurs in the incompletely vascularized, developing retina of low birth-weight preterm neonates.

Secondary outcomes

  1. Percentage of Participants Requiring Interventions With a Second Modality for ROP at Week 24

    Time frame: Week 24

    Intervention for ROP in either eye at or before the 24-week assessment visit with a treatment modality other than the modality of the first study treatment. Only descriptive analysis done.

  2. Number of Participants Experiencing an Event, From the First Study Treatment to the Last Study Visit

    Time frame: Day 1 (after initiation of study treatment) up to study exit (Day 169)

    An event was defined as death, treatment switch, or the first occurrence of unfavorable structural outcomes in either eye. Only descriptive analysis done.

  3. Percentage of Participants Having Recurrent ROP and Receiving Any Post-baseline Intervention at or Before Week 24

    Time frame: Week 24

    Recurrence of ROP is defined as subjects receiving any post-baseline intervention in either eye at or before 24 weeks (ranibizumab re-treatment or switch to laser in the ranibizumab groups, switch to ranibizumab treatment in the laser group). Zone I consists of a circle, the radius of which extends from the center of the optic disc to twice the distance from the center of the optic disc to the center of the macula. Zone II extends centrifugally from the edge of zone I to the nasal ora serrata. Only descriptive analysis done.

  4. Percent of Participants With Ocular Adverse Events by Primary System Organ (SOCs) at Week 24

    Time frame: Week 24

    Percent of Participants with Ocular Adverse Events regardless of Study Treatment and Procedure Relationship by Primary System Organ (SOCs) reported categorically (Mild, Moderate, Severe) 24 weeks after the first study treatment. Only descriptive analysis done.

  5. Mean Change in Ranibizumab Concentration in Pharmacokinetic Serum Samples Over Time at Day 1, Day 15 and Day 29

    Time frame: Day 1 (Baseline), Day 15 and Day 29

    Blood samples for the determination of ranibizumab concentrations were collected in the Ranibizumab treatment arms only at the following time points: within 24 hours after the first administration of ranibizumab, at Day 15 and at Day 29. Only descriptive analysis done.

  6. Mean Change in Vascular Endothelial Growth Factor (VEGF) Levels Over Time at Day 1, Day 15 and Day 29

    Time frame: Day 1 (Baseline), Day 15 and Day 29

    Blood samples for the determination of systemic VEGF levels were collected at the following time points: before the first investigational treatment, at Day 15 and at Day 29. Only descriptive analysis done.

  7. Total Number of Ranibizumab Injections Received at Week 24

    Time frame: Week 24

    Patients randomized to receive Ranibizumab 0.1 mg or 0.2 mg received a single dose of intravitreal Ranibizumab to each eye on Day 1 (Baseline). Only descriptive analysis done.

  8. Percent of Participants With Non-Ocular Adverse Events by Primary System Organ (SOCs) at Week 24

    Time frame: Week 24

    Percent of Participants with Non-Ocular Adverse Events regardless of Study Treatment and Procedure Relationship by Primary System Organ (SOCs) reported categorically (Mild, Moderate, Severe) 24 weeks after the first study treatment. Only descriptive analysis done.

  9. Mean Change From Baseline in Vital Signs (Body Length, Head Circumference and Knee to Heel Length) at Day 85 and Day 169

    Time frame: Baseline, Day 85, Day 169

    Body Length, Head Circumference and Knee to Heel Length were assessed. Only descriptive analysis done.

  10. Mean Change From Baseline in Vital Signs (Weight) at Day 85 and Day 169

    Time frame: Baseline, Day 85, Day 169

    Body weight was measured. Only descriptive analysis done.

  11. Mean Change From Baseline in Vital Signs (Sitting Blood Pressure) at Day 85 and Day 169

    Time frame: Baseline, Day 85, Day 169

    Blood Pressure measurements were not required by the protocol. Instead, the most recent Systolic and Diastolic Blood Pressure expressed in millimeters of mercury (mmHg) measured as part of the routine clinical care were used. Only descriptive analysis done.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: RAINBOW

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 3, 2015
Registry last updated
Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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