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

Novartis Pharmaceuticals224 enrolled

Overview

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).

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

224

Conditions

Retinopathy of Prematurity

Interventions

RanibizumabDRUG

Administered as an intravitreal injection

Laser therapyPROCEDURE

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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)

Locations (86)

Outcomes

Primary Outcomes

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

Time frame: Week 24

Secondary Outcomes

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

Time frame: Week 24

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

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

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

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

Time frame: Week 24

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

Data from ClinicalTrials.gov

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Novartis Investigative Site

Loma Linda, California, United States

Novartis Investigative Site

Sacramento, California, United States

Novartis Investigative Site

Aurora, Colorado, United States

Novartis Investigative Site

Chicago, Illinois, United States

Novartis Investigative Site

Louisville, Kentucky, United States

Novartis Investigative Site

Baltimore, Maryland, United States

Novartis Investigative Site

Boston, Massachusetts, United States

Novartis Investigative Site

Ann Arbor, Michigan, United States

Novartis Investigative Site

Rochester, New York, United States

Novartis Investigative Site

Austin, Texas, United States

...and 76 more locations