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RAINBOW sStudy


Title RAINBOW study: a randomized controlled study evaluating the fficacy and safety of ranibizumab compared with laser therapy for the treatment of infants born prematurely with retinopathy of prematurity
Therapeutic Area Retinopathy of Prematurity
Principal Investigator Alexa Smith, MD
Gender Both
Contact Elyse Shenberger
617 636-7401
More Information https://clinicaltrials.gov/ct2/show/NCT02375971

Overview

The RAINBOW study is a clinical research study that will help doctors learn whether a drug called ranibizumab works in treating retinopathy of prematurity. Ranibizumab is a drug that blocks a substance in the body called vascular endothelial growth factor, or VEGF. This controls the growth of blood vessels in the back of the eye, and premature babies who develop retinopathy of prematurity have too much of this substance.  The purpose of the study is to determine if ranibizumab can help those blood vessels grow normally again, and the study will look at whether one or both doses of the drug work, compared to the current treatment, laser therapy.

Study Details

Inclusion Criteria

  • Male or female infants with birthweight less than 1500g
  • Bilateral ROP with 1 of the following retinal findings in each eye:
    • Zone 1, stage 1+, 2+, or 3+ disease
    • Zone II, stage 3+ disease
    • Aggressive Posterior ROP (AP-ROP)

Exclusion Criteria

  • Previous ROP treatment or sensitivity to anti-VEGF agents
  • History of hydrocephalus requiring treatment
  • Occular infection within 5 days of first investigational treatment

Study Requirements

Your baby will be randomized to receive either laser therapy or renibizumab, and can receive additional treatments (either laser or drug therapy) if needed. Blood samples will be collected pre-treatment, 24-hours post-treatment and at days 15 and 29 post-treatment. Your baby will have 12 retinal follow-up visits post-treatment, some of which will be conducted in the NICU at Tufts, and the remaining will be conducted as an outpatient in the ophthalmology clinic.