Rainbow Extension Study

Part of paid clinical trials in Sacramento, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02640664
Phase
PHASE3
Status
Completed

Conditions

  • Retinopathy of Prematurity (ROP)

Eligibility Criteria

Sex
ALL
Age
6 Months - 5 Years
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required

Study Details

The purpose of this study was 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 (NCT02375971)

Key Dates

First listed
Dec 29, 2015
Start date
Jun 16, 2016
Status verified
Jan 2023
Primary completion
Apr 21, 2022
Completion
Apr 21, 2022

Study Design

Enrollment
180 participants (actual)
Allocation
NON_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
  • No Intervention: Laser therapy
    Laser therapy

Primary Outcome Measure

Visual Acuity (VA) of the Better-seeing Eye at the Participant's Fifth Birthday Visit - Comparison Between Treatment Arms [ Time Frame: at the participant's fifth birthday visit (maximum 5 years and 4 months post core baseline visit) ]

Locations (9)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteSacramentoCalifornia95817-
Novartis Investigative SiteAuroraColorado80045-
Novartis Investigative SiteChicagoIllinois60612-
Novartis Investigative SiteLouisvilleKentucky40202-
Novartis Investigative SiteBaltimoreMaryland21201-
Novartis Investigative SiteAnn ArborMichigan48105-
Novartis Investigative SiteRochesterNew York14642-
Novartis Investigative SiteAustinTexas78705-
Novartis Investigative SiteMorgantownWest Virginia26506-

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Novartis Investigative Site· Sacramento, CANovartis Investigative Site· Aurora, CONovartis Investigative Site· Chicago, ILNovartis Investigative Site· Louisville, KYNovartis Investigative Site· Baltimore, MDNovartis Investigative Site· Ann Arbor, MI

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