Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
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).
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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)
Clareo Health | RAINBOW Study: RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity
