Phase 3
Completed N=225
RAINBOW Study: RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity
Source: ClinicalTrials.gov NCT02375971 ↗Enrolled (actual)
225
Serious AEs
33.9%
Results posted
Jul 2018
Primary outcomePrimary: Percentage of Participants With Absence of Active ROP and Absence of Unfavorable Structural Outcomes in Both Eyes at Week 24 — 80.0; 75.0; 66.2 Percentage of Participants — p=0.0254
◆ Published Evidence
Highly cited
438citations · ~63 / year
Ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW): an open-label randomised controlled trial.
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).
Linked Publications (2)
-
Ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW): an open-label randomised controlled trial.
-
Time Course of Retinopathy of Prematurity Regression and Reactivation After Treatment with Ranibizumab or Laser in the RAINBOW Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Absence of Active ROP and Absence of Unfavorable Structural Outcomes in Both Eyes at Week 24 |
80.0; 75.0; 66.2 | 0.0254 sig |
| SECONDARY Percentage of Participants Requiring Interventions With a Second Modality for ROP at Week 24 |
14.9; 16.9; 24.3 | — |
| SECONDARY Number of Participants Experiencing an Event, From the First Study Treatment to the Last Study Visit |
14; 18; 23 | — |
| SECONDARY Percentage of Participants Having Recurrent ROP and Receiving Any Post-baseline Intervention at or Before Week 24 |
31.1; 31.2; 18.9; 35.7; 53.3; 28.6 | — |
| SECONDARY Percent of Participants With Ocular Adverse Events by Primary System Organ (SOCs) at Week 24 |
23.3; 32.9; 17.4; 4.1; 6.6; 13.0 | — |
| SECONDARY Mean Change in Ranibizumab Concentration in Pharmacokinetic Serum Samples Over Time at Day 1, Day 15 and Day 29 |
24700.0; 12100.0; 5830.0; 27700.0; 1810.0; 732.0 | — |
| SECONDARY Mean Change in Vascular Endothelial Growth Factor (VEGF) Levels Over Time at Day 1, Day 15 and Day 29 |
239.0; 230.0; 232.0; 239.0; 239.0; 233.0 | — |
| SECONDARY Total Number of Ranibizumab Injections Received at Week 24 |
73; 76; 13 | — |
| SECONDARY Percent of Participants With Non-Ocular Adverse Events by Primary System Organ (SOCs) at Week 24 |
37.0; 27.6; 31.9; 24.7; 34.2; 27.5 | — |
| SECONDARY Mean Change From Baseline in Vital Signs (Body Length, Head Circumference and Knee to Heel Length) at Day 85 and Day 169 |
10.1; 11.0; 11.1; 18.7; 18.6; 19.0 | — |
| SECONDARY Mean Change From Baseline in Vital Signs (Weight) at Day 85 and Day 169 |
2198.9; 2149.9; 2182.7; 3794.3; 3716.7; 3826.0 | — |
| SECONDARY Mean Change From Baseline in Vital Signs (Sitting Blood Pressure) at Day 85 and Day 169 |
8.1; 7.0; 9.8; 6.3; 9.4; 15.5 | — |
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)
Data sourced from ClinicalTrials.gov (NCT02375971) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.