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

• Status: Completed
• Trial end date: 2017-12-14
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Ranibizumab

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)