Trial · NCT02375971
RAINBOW Study: RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity
NCT02375971, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2018-07-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. RAINBOW Study: RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity. Trials, record NCT02375971. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02375971
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RAINBOW Study: RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity
- NCT number
- NCT02375971
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 224 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Retinopathy of Prematurity
- Interventions
- Ranibizumab, Laser therapy
- First posted
- 2015-03-03
- Last updated
- 2018-11-14
- Other registries' IDs
- eudract:2014-003041-10
- Results first posted
- 2018-07-31
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Absence of Active ROP and Absence of Unfavorable Structural Outcomes in Both Eyes at Week 24 | Week 24 | To achieve this outcome, patients must fulfill all the following criteria, 1) survival, 2) no intervention with a second modality for ROP, 3) absence of active ROP and 4) absence of unfavorable structural outcome. Retinopathy of prematurity (ROP) is a pathologic process that occurs in the incompletely vascularized, developing retina of low birth-weight preterm neonates. |
| Secondary | Percentage of Participants Requiring Interventions With a Second Modality for ROP at Week 24 | Week 24 | Intervention for ROP in either eye at or before the 24-week assessment visit with a treatment modality other than the modality of the first study treatment. Only descriptive analysis done. |
| Secondary | Number of Participants Experiencing an Event, From the First Study Treatment to the Last Study Visit | Day 1 (after initiation of study treatment) up to study exit (Day 169) | An event was defined as death, treatment switch, or the first occurrence of unfavorable structural outcomes in either eye. Only descriptive analysis done. |
| Secondary | Percentage of Participants Having Recurrent ROP and Receiving Any Post-baseline Intervention at or Before Week 24 | Week 24 | Recurrence of ROP is defined as subjects receiving any post-baseline intervention in either eye at or before 24 weeks (ranibizumab re-treatment or switch to laser in the ranibizumab groups, switch to ranibizumab treatment in the laser group). Zone I consists of a circle, the radius of which extends from the center of the optic disc to twice the distance from the center of the optic disc to the center of the macula. Zone II extends centrifugally from the edge of zone I to the nasal ora serrata. Only descriptive analysis done. |
| Secondary | Percent of Participants With Ocular Adverse Events by Primary System Organ (SOCs) at Week 24 | Week 24 | Percent of Participants with Ocular Adverse Events regardless of Study Treatment and Procedure Relationship by Primary System Organ (SOCs) reported categorically (Mild, Moderate, Severe) 24 weeks after the first study treatment. Only descriptive analysis done. |
| Secondary | Mean Change in Ranibizumab Concentration in Pharmacokinetic Serum Samples Over Time at Day 1, Day 15 and Day 29 | Day 1 (Baseline), Day 15 and Day 29 | Blood samples for the determination of ranibizumab concentrations were collected in the Ranibizumab treatment arms only at the following time points: within 24 hours after the first administration of ranibizumab, at Day 15 and at Day 29. Only descriptive analysis done. |
| Secondary | Mean Change in Vascular Endothelial Growth Factor (VEGF) Levels Over Time at Day 1, Day 15 and Day 29 | Day 1 (Baseline), Day 15 and Day 29 | Blood samples for the determination of systemic VEGF levels were collected at the following time points: before the first investigational treatment, at Day 15 and at Day 29. Only descriptive analysis done. |
| Secondary | Total Number of Ranibizumab Injections Received at Week 24 | Week 24 | Patients randomized to receive Ranibizumab 0.1 mg or 0.2 mg received a single dose of intravitreal Ranibizumab to each eye on Day 1 (Baseline). Only descriptive analysis done. |
| Secondary | Percent of Participants With Non-Ocular Adverse Events by Primary System Organ (SOCs) at Week 24 | Week 24 | Percent of Participants with Non-Ocular Adverse Events regardless of Study Treatment and Procedure Relationship by Primary System Organ (SOCs) reported categorically (Mild, Moderate, Severe) 24 weeks after the first study treatment. Only descriptive analysis done. |
| Secondary | Mean Change From Baseline in Vital Signs (Body Length, Head Circumference and Knee to Heel Length) at Day 85 and Day 169 | Baseline, Day 85, Day 169 | Body Length, Head Circumference and Knee to Heel Length were assessed. Only descriptive analysis done. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Absence of Active ROP and Absence of Unfavorable Structural Outcomes in Both Eyes at Week 24 | Week 24 | The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Requiring Interventions With a Second Modality for ROP at Week 24 | Week 24 | The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants Experiencing an Event, From the First Study Treatment to the Last Study Visit | Day 1 (after initiation of study treatment) up to study exit (Day 169) | The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered. | Participants | NUMBER |
| SECONDARY | Percentage of Participants Having Recurrent ROP and Receiving Any Post-baseline Intervention at or Before Week 24 | Week 24 | The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered. | Percentage of participants | NUMBER |
| SECONDARY | Percent of Participants With Ocular Adverse Events by Primary System Organ (SOCs) at Week 24 | Week 24 | The Safety Set was considered. | Percent of participants | NUMBER |
| SECONDARY | Mean Change in Ranibizumab Concentration in Pharmacokinetic Serum Samples Over Time at Day 1, Day 15 and Day 29 | Day 1 (Baseline), Day 15 and Day 29 | The PK Set, which consisted of all participants with at least one valid PK concentration value, was considered. | picogram/milliliter (pg/mL) | MEAN |
| SECONDARY | Mean Change in Vascular Endothelial Growth Factor (VEGF) Levels Over Time at Day 1, Day 15 and Day 29 | Day 1 (Baseline), Day 15 and Day 29 | The VEGF Set, which consisted of all participants with at least one valid VEGF concentration value, was considered. | picogram/milliliter (pg/mL) | MEAN |
| SECONDARY | Total Number of Ranibizumab Injections Received at Week 24 | Week 24 | The Safety Set was considered. | Injections | NUMBER |
| SECONDARY | Percent of Participants With Non-Ocular Adverse Events by Primary System Organ (SOCs) at Week 24 | Week 24 | The Safety Set was considered. | Percent of participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Vital Signs (Body Length, Head Circumference and Knee to Heel Length) at Day 85 and Day 169 | Baseline, Day 85, Day 169 | The Safety Set was considered. Only patients with evaluable data at each time point were analyzed for that time point. | centimeter (cm) | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group99
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Absence of Active ROP and Absence of Unfavorable Structural Outcomes in Both Eyes at Week 24 | Ranibizumab 0.2 mg | 80.0 | Percentage of Participants | ||
| Percentage of Participants With Absence of Active ROP and Absence of Unfavorable Structural Outcomes in Both Eyes at Week 24 | Ranibizumab 0.1 mg | 75.0 | Percentage of Participants | ||
| Percentage of Participants With Absence of Active ROP and Absence of Unfavorable Structural Outcomes in Both Eyes at Week 24 | Laser Therapy | 66.2 | Percentage of Participants | ||
| Percentage of Participants Requiring Interventions With a Second Modality for ROP at Week 24 | Ranibizumab 0.2 mg | 14.9 | Percentage of participants | ||
| Percentage of Participants Requiring Interventions With a Second Modality for ROP at Week 24 | Ranibizumab 0.1 mg | 16.9 | Percentage of participants | ||
| Percentage of Participants Requiring Interventions With a Second Modality for ROP at Week 24 | Laser Therapy | 24.3 | Percentage of participants | ||
| Number of Participants Experiencing an Event, From the First Study Treatment to the Last Study Visit | Ranibizumab 0.2 mg | 14 | Participants | ||
| Number of Participants Experiencing an Event, From the First Study Treatment to the Last Study Visit | Ranibizumab 0.1 mg | 18 | Participants | ||
| Number of Participants Experiencing an Event, From the First Study Treatment to the Last Study Visit | Laser Therapy | 23 | Participants | ||
| Percentage of Participants Having Recurrent ROP and Receiving Any Post-baseline Intervention at or Before Week 24 | Ranibizumab 0.2 mg | All participants | 31.1 | Percentage of participants |
1 to 10 of 99Source ClinicalTrials.gov
See all 99 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment (Day 1 - Baseline) | STARTED | Ranibizumab 0.2 mg | 74 | |
| Treatment (Day 1 - Baseline) | STARTED | Ranibizumab 0.1 mg | 77 | |
| Treatment (Day 1 - Baseline) | STARTED | Laser Therapy | 74 | |
| Treatment (Day 1 - Baseline) | Safety Set | Ranibizumab 0.2 mg | 73 | |
| Treatment (Day 1 - Baseline) | Safety Set | Ranibizumab 0.1 mg | 76 | |
| Treatment (Day 1 - Baseline) | Safety Set | Laser Therapy | 69 | |
| Treatment (Day 1 - Baseline) | VEGF Set | Ranibizumab 0.2 mg | 19 | |
| Treatment (Day 1 - Baseline) | VEGF Set | Ranibizumab 0.1 mg | 26 | |
| Treatment (Day 1 - Baseline) | VEGF Set | Laser Therapy | 51 | |
| Treatment (Day 1 - Baseline) | PK Set | Ranibizumab 0.2 mg | 49 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events360
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Ranibizumab 0.2 mg | 4 | 73 | |
| other | Anaemia | Blood and lymphatic system disorders | Ranibizumab 0.1 mg | 8 | 76 | |
| other | Anaemia | Blood and lymphatic system disorders | Laser | 5 | 69 | |
| other | Anaemia neonatal | Blood and lymphatic system disorders | Ranibizumab 0.2 mg | 2 | 73 | |
| other | Anaemia neonatal | Blood and lymphatic system disorders | Ranibizumab 0.1 mg | 4 | 76 | |
| other | Anaemia neonatal | Blood and lymphatic system disorders | Laser | 1 | 69 | |
| other | Bradycardia | Cardiac disorders | Ranibizumab 0.2 mg | 2 | 73 | |
| other | Bradycardia | Cardiac disorders | Ranibizumab 0.1 mg | 5 | 76 | |
| other | Bradycardia | Cardiac disorders | Laser | 1 | 69 | |
| other | Conjunctival haemorrhage | Eye disorders | Ranibizumab 0.2 mg | 6 | 73 |
1 to 10 of 360Source ClinicalTrials.gov
See all 360 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ranibizumab 0.2 mg | 4 | 73 |
| Total, all-cause mortality | Ranibizumab 0.1 mg | 4 | 76 |
| Total, all-cause mortality | Laser | 4 | 69 |
| Total, other adverse events | Ranibizumab 0.2 mg | 43 | 73 |
| Total, other adverse events | Ranibizumab 0.1 mg | 47 | 76 |
| Total, other adverse events | Laser | 37 | 69 |
| Total, serious adverse events | Ranibizumab 0.2 mg | 26 | 73 |
| Total, serious adverse events | Ranibizumab 0.1 mg | 24 | 76 |
| Total, serious adverse events | Laser | 24 | 69 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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