Phase 3
N=180
Rainbow Extension Study
Retinopathy of Prematurity (ROP)
Bottom Line
View on ClinicalTrials.gov: NCT02640664 ↗Enrolled (actual)
180
Serious AEs
41.1%
Results posted
Feb 2023
Primary outcome: Primary: Visual Acuity (VA) of the Better-seeing Eye at the Participant's Fifth Birthday Visit - Comparison Between Treatment Arms — 66.8; 64.6; 62.1 Score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ranibizumab (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity (VA) of the Better-seeing Eye at the Participant's Fifth Birthday Visit - Comparison Between Treatment Arms |
66.8; 64.6; 62.1 | — |
| SECONDARY Number of Participants With Ocular Adverse Events (AEs) Regardless of Study Treatment or Procedure Relationship by Preferred Term |
19; 26; 22 | — |
| SECONDARY Number of Participants With Non-ocular Adverse Events (AEs) Regardless of Study Treatment or Procedure Relationship (Greater Than or Equal to 3% in Any Arm) by Preferred Term |
46; 53; 46 | — |
| SECONDARY Visual Acuity (VA) of the Worse-seeing Eye at the Participant's Fifth Birthday Visit - Comparison Between Treatment Arms |
60.2; 53.8; 52.2 | — |
| SECONDARY Number of Participants With Absence of Active Retinopathy of Prematurity (ROP) at 40 Weeks Post Core Baseline Visit |
55; 58; 46; 55; 58; 46 | — |
| SECONDARY Number of Participants With Absence of Active Retinopathy of Prematurity (ROP) at 52 Weeks Post Core Baseline Visit |
58; 63; 49 | — |
| SECONDARY Number of Participants With Absence of All Ocular Structural Abnormalities at or Before 40 Weeks Post Baseline Visit |
59; 61; 47 | — |
| SECONDARY Number of Participants With Absence of All Ocular Structural Abnormalities at or Before the Participant's Fifth Birthday Visit |
59; 61; 47 | — |
| SECONDARY Number of Participants With Absence of Individual Ocular Structural Abnormalities at or Before 40 Weeks Post Baseline Visit |
59; 63; 49; 60; 65; 53 | — |
| SECONDARY Number of Participants With Absence of Individual Ocular Structural Abnormalities at or Before the Participant's Fifth Birthday Visit |
59; 63; 49; 60; 65; 52 | — |
| SECONDARY Number of Participants With Absence of All Ocular Structural Abnormalities at or Before Participant's 2 Years Corrected Age Visit |
59; 61; 47 | — |
| SECONDARY Number of Participants With Absence of Individual Ocular Structural Abnormalities at or Before Participant's 2 Years Corrected Age Visit |
59; 63; 49; 60; 65; 52 | — |
| SECONDARY Number of Participants With Recurrence of ROP up to 40 Weeks Post Baseline Visit in the Core Study |
19; 22; 11 | — |
| SECONDARY Number of Participants With Recurrence of ROP up to 52 Weeks Post Baseline Visit in the Core Study |
19; 22; 11 | — |
| SECONDARY Number of Ranibizumab Injections Received Per Participant Over the Whole Safety Observation Period |
2.5; 2.5; 2.4 | — |
| SECONDARY Refraction Status: Summary of Participants at Participant's 2 Years Corrected Age |
-0.697; -0.713; -1.793; -0.825; -0.829; -1.516 | — |
| SECONDARY Refraction Status: Summary of Participants at the Participant's Fifth Birthday Visit |
-0.601; -0.859; -1.883; -0.904; -1.074; -1.706 | — |
| SECONDARY Change From Baseline in Weight |
8695.9; 8461.7; 8840.6; 14611.9; 14324.7; 14689.4 | — |
| SECONDARY Change From Baseline in Head Circumference |
16.5; 16.2; 17.2 | — |
| SECONDARY Change From Baseline in Sitting Diastolic Blood Pressure |
16.7; 13.6; 16.5 | — |
| SECONDARY Change From Baseline in Sitting Systolic Blood Pressure |
20.6; 16.2; 17.6 | — |
| SECONDARY Number of Participants With the Summary of Respiratory Function Status |
6; 4; 2; 47; 50; 45 | — |
| SECONDARY Number of Participants With Hearing Impairment of Any Type |
2; 2; 4 | — |
| SECONDARY Duration of Hospitalization |
111.1; 116.2; 95.7 | — |
| SECONDARY Weight at the Time of First Hospital Discharge |
2910.9; 2966.5; 2658.7 | — |
Summary
The purpose of this study was to evaluate the long term efficacy and safety of intravitreal ranibizumab compared with laser ablation therapy in patients who were treated for retinopathy of prematurity (ROP) in the core study CRFB002H2301 (NCT02375971)
Eligibility Criteria
Inclusion Criteria
- Signed informed consent from parent(s) or legal guardian(s), in compliance with local requirements
- The patient successfully completed the core study H2301, as defined by providing assessments at the Visit 112 (the last scheduled visit in the core study) or, if appropriate, at the last of the additional assessment visits as per protocol in H2301, whichever was latest
- The patient received study treatment in both eyes at baseline of study H2301
Exclusion Criteria
- Patient had a medical condition or personal circumstance which precluded study participation or compliance with study procedures, as assessed by the Investigator
- Patient had been discontinued from the core study H2301 at any time
Data sourced from ClinicalTrials.gov (NCT02640664). 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.