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

Part of paid clinical trials in Loma Linda, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02375971
Phase
PHASE3
Status
Completed

Conditions

  • Retinopathy of Prematurity

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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).

Key Dates

First listed
Mar 3, 2015
Start date
Dec 30, 2015
Status verified
Oct 2018
Primary completion
Dec 14, 2017
Completion
Dec 14, 2017

Study Design

Enrollment
224 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ranibizumab 0.2 mg
    1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required
  • Experimental: Ranibizumab 0.1 mg
    1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required
  • Active Comparator: Laser therapy
    Laser treatment to each eye on Day 1 (Baseline), with supplementary treatments allowed

Primary Outcome Measure

Percentage of Participants With Absence of Active ROP and Absence of Unfavorable Structural Outcomes in Both Eyes at Week 24 [ Time Frame: Week 24 ]

Locations (12)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteLoma LindaCalifornia92354-
Novartis Investigative SiteSacramentoCalifornia95817-
Novartis Investigative SiteAuroraColorado80045-
Novartis Investigative SiteChicagoIllinois60612-
Novartis Investigative SiteLouisvilleKentucky40208-
Novartis Investigative SiteBaltimoreMaryland21201-
Novartis Investigative SiteBostonMassachusetts02111-
Novartis Investigative SiteAnn ArborMichigan48105-
Novartis Investigative SiteRochesterNew York14642-
Novartis Investigative SiteAustinTexas78705-
Novartis Investigative SiteSalt Lake CityUtah84132-
Novartis Investigative SiteMorgantownWest Virginia26506-

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Novartis Investigative Site· Loma Linda, CANovartis Investigative Site· Sacramento, CANovartis Investigative Site· Aurora, CONovartis Investigative Site· Chicago, ILNovartis Investigative Site· Louisville, KYNovartis Investigative Site· Baltimore, MD

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