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

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).

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)