RAINBOW Study: RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity
Condition: Retinopathy of Prematurity
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Intervention: Ranibizumab; Laser therapy
Intervention description: Administered as an intravitreal injection; Transpupillary diode or frequency-doubled yttrium aluminum garnet (YAG) laser ablative therapy, following anesthesia or sedation
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 224.0
Sex: All
Healthy volunteers: No
Keywords: intravitreal ranibizumab; laser ablation therapy; retinopathy of prematurity; preterm infants; RAINBOW

Summary:

      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).
    

Eligibility criteria:

        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)