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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02375971
• Date of registration: 18/02/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: RAINBOW Study: RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity RAINBOW
• Scientific title: RAINBOW Study: a Randomized, Controlled Study Evaluating the Efficacy and Safety of RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity
• Date of first enrolment: December 30, 2015
• Target sample size: 224
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02375971
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Austria, Belgium, Canada, Chile, Colombia, Croatia, Czech Republic, Czechia, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Lithuania, Malaysia, Mexico, Poland, Romania, Russian Federation, Saudi Arabia, Slovakia, Sweden, Taiwan, Turkey, United Arab Emirates, United Kingdom, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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)



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Retinopathy of Prematurity

Intervention(s)

Procedure: Laser therapy

Drug: Ranibizumab

Primary Outcome(s)

Percentage of Participants With Absence of Active ROP and Absence of Unfavorable Structural Outcomes in Both Eyes at Week 24 [Time Frame: Week 24]

Secondary Outcome(s)

Percentage of Participants Having Recurrent ROP and Receiving Any Post-baseline Intervention at or Before Week 24 [Time Frame: Week 24]

Mean Change From Baseline in Vital Signs (Body Length, Head Circumference and Knee to Heel Length) at Day 85 and Day 169 [Time Frame: Baseline, Day 85, Day 169]

Number of Participants Experiencing an Event, From the First Study Treatment to the Last Study Visit [Time Frame: Day 1 (after initiation of study treatment) up to study exit (Day 169)]

Mean Change in Ranibizumab Concentration in Pharmacokinetic Serum Samples Over Time at Day 1, Day 15 and Day 29 [Time Frame: Day 1 (Baseline), Day 15 and Day 29]

Mean Change From Baseline in Vital Signs (Weight) at Day 85 and Day 169 [Time Frame: Baseline, Day 85, Day 169]

Percentage of Participants Requiring Interventions With a Second Modality for ROP at Week 24 [Time Frame: Week 24]

Total Number of Ranibizumab Injections Received at Week 24 [Time Frame: Week 24]

Percent of Participants With Ocular Adverse Events by Primary System Organ (SOCs) at Week 24 [Time Frame: Week 24]

Mean Change in Vascular Endothelial Growth Factor (VEGF) Levels Over Time at Day 1, Day 15 and Day 29 [Time Frame: Day 1 (Baseline), Day 15 and Day 29]

Mean Change From Baseline in Vital Signs (Sitting Blood Pressure) at Day 85 and Day 169 [Time Frame: Baseline, Day 85, Day 169]

Percent of Participants With Non-Ocular Adverse Events by Primary System Organ (SOCs) at Week 24 [Time Frame: Week 24]

Secondary ID(s)

2014-003041-10

CRFB002H2301

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 31/07/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02375971