Trial · NCT02640664
Rainbow Extension Study
NCT02640664, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2023-02-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Rainbow Extension Study. Trials, record NCT02640664. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02640664
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rainbow Extension Study
- NCT number
- NCT02640664
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 180 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Retinopathy of Prematurity (ROP)
- Interventions
- Ranibizumab
- First posted
- 2015-12-29
- Last updated
- 2023-02-13
- Other registries' IDs
- eudract:2014-004048-36
- Results first posted
- 2023-02-13
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Visual Acuity (VA) of the Better-seeing Eye at the Participant's Fifth Birthday Visit - Comparison Between Treatment Arms | at the participant's fifth birthday visit (maximum 5 years and 4 months post core baseline visit) | The VA assessment at the child's 5th birthday visit was performed using Early Treatment Diabetic Retinopathy Study (ETDRS) methodology. VA measurements were taken in a sitting position at an initial test distance of 3 meters using Lea Symbols charts. Scores represented the number of optotypes (Lea symbols) the participant identified and ranged from 0 to 100, with higher scores indicating better visual acuity. VA was tested in each eye, using the child's current refractive index. The better-seeing eye was defined as the eye with the higher ETDRS score at the 5th birthday visit. If both eyes had the same ETDRS score, then the right eye was assigned as the better-seeing eye. |
| Secondary | Number of Participants With Ocular Adverse Events (AEs) Regardless of Study Treatment or Procedure Relationship by Preferred Term | throughout the study, approximately 5 years | Number of participants with ocular AEs starting during the core study and ongoing at extension baseline, or starting on/after extension baseline were reported. |
| 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 | throughout the study, approximately 5 years | Number of participants with non-ocular adverse events regardless of study treatment or procedure relationship (greater than or equal to 3% in any arm) by preferred term were reported. |
| Secondary | Visual Acuity (VA) of the Worse-seeing Eye at the Participant's Fifth Birthday Visit - Comparison Between Treatment Arms | at the participant's fifth birthday visit (maximum 5 years and 4 months post core baseline visit) | The VA assessment at the child's 5th birthday visit was performed using Early Treatment Diabetic Retinopathy Study (ETDRS) methodology. VA measurements were taken in a sitting position at an initial test distance of 3 meters using Lea Symbols charts. Scores represented the number of optotypes (Lea symbols) the participant identified and ranged from 0 to 100, with higher scores indicating better visual acuity. VA was tested in each eye, using the child's current refractive index. The worse-seeing eye was the eye with a lower ETDRS score at the 5th birthday visit. If both eyes had the same ETDRS score, then the left eye was assigned as the worse-seeing eye. |
| Secondary | Number of Participants With Absence of Active Retinopathy of Prematurity (ROP) at 40 Weeks Post Core Baseline Visit | at 40 weeks post core baseline visit | The absence of active ROP in both eyes is defined by the absence of all of the following features: (1) Vessel dilatation of plus disease in at least 2 quardrants (some persisting tortuosity is allowed), (2) Extra-retina vessels extending from the retina into the vitreous and judged to be a sign of active ROP disease. |
| Secondary | Number of Participants With Absence of Active Retinopathy of Prematurity (ROP) at 52 Weeks Post Core Baseline Visit | at 52 weeks post core baseline visit | The absence of active ROP in both eyes is defined by the absence of all of the following features: (1) Vessel dilatation of plus disease in at least 2 quardrants (some persisting tortuosity is allowed), (2) Extra-retina vessels extending from the retina into the vitreous and judged to be a sign of active ROP disease. |
| Secondary | Number of Participants With Absence of All Ocular Structural Abnormalities at or Before 40 Weeks Post Baseline Visit | at or before 40 weeks post baseline visit | The absence of all ocular structural abnormalities is defined by the absence of all of the following fundus features in both eyes at or before the given time point: (1) Substantial temporal retinal vessel dragging causing abnormal structural features/macular Ectopia, (2) Retrolental membrane obscuring the view of the posterior pole, (3) Posterior retinal fold involving the macula, (4) Retinal detachment involving the macula |
| Secondary | Number of Participants With Absence of All Ocular Structural Abnormalities at or Before the Participant's Fifth Birthday Visit | at or before the participant's fifth birthday visit (up to maximum 5 years and 4 months post core baseline visit) | The absence of all ocular structural abnormalities is defined by the absence of all of the following fundus features in both eyes at or before the given time point: (1) Substantial temporal retinal vessel dragging causing abnormal structural features/macular Ectopia, (2) Retrolental membrane obscuring the view of the posterior pole, (3) Posterior retinal fold involving the macula, (4) Retinal detachment involving the macula |
| Secondary | Number of Participants With Absence of Individual Ocular Structural Abnormalities at or Before 40 Weeks Post Baseline Visit | at or before 40 weeks post baseline visit | Number of participants with absence of each structural abnormality in both eyes at or before the given time point: (1) Substantial temporal retinal vessel dragging causing abnormal structural features/macular Ectopia, (2) Retrolental membrane obscuring the view of the posterior pole, (3) Posterior retinal fold involving the macula, (4) Retinal detachment involving the macula, (5) Retinal detachment not involving the macula, (6) Pre-retinal fibrosis |
| Secondary | Number of Participants With Absence of Individual Ocular Structural Abnormalities at or Before the Participant's Fifth Birthday Visit | at or before the participant's fifth birthday visit (up to maximum 5 years and 4 months post core baseline visit) | Number of participants with absence of each structural abnormality in both eyes at or before the given time point: (1) Substantial temporal retinal vessel dragging causing abnormal structural features/macular Ectopia, (2) Retrolental membrane obscuring the view of the posterior pole, (3) Posterior retinal fold involving the macula, (4) Retinal detachment involving the macula, (5) Retinal detachment not involving the macula, (6) Pre-retinal fibrosis, (7) Optic disc pallor, (8) Optic disc swelling, (9) Pigmentary disturbance in the macula, (10) Atrophic changes in the macula |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Visual Acuity (VA) of the Better-seeing Eye at the Participant's Fifth Birthday Visit - Comparison Between Treatment Arms | at the participant's fifth birthday visit (maximum 5 years and 4 months post core baseline visit) | Extension Safety Set: defined as the subset of the participants from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Ocular Adverse Events (AEs) Regardless of Study Treatment or Procedure Relationship by Preferred Term | throughout the study, approximately 5 years | Extension Safety Set: defined as the subset of the patients from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | throughout the study, approximately 5 years | Extension Safety Set: defined as the subset of the patients from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Visual Acuity (VA) of the Worse-seeing Eye at the Participant's Fifth Birthday Visit - Comparison Between Treatment Arms | at the participant's fifth birthday visit (maximum 5 years and 4 months post core baseline visit) | Extension Safety Set: defined as the subset of the patients from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Absence of Active Retinopathy of Prematurity (ROP) at 40 Weeks Post Core Baseline Visit | at 40 weeks post core baseline visit | Extension Safety Set: defined as the subset of the patients from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. Number analyzed represents the number of participants with at least one non-missing value for the specific category and, therefore, it's not the same as the total number of participants analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Absence of Active Retinopathy of Prematurity (ROP) at 52 Weeks Post Core Baseline Visit | at 52 weeks post core baseline visit | Extension Safety Set: defined as the subset of the patients from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Absence of All Ocular Structural Abnormalities at or Before 40 Weeks Post Baseline Visit | at or before 40 weeks post baseline visit | Extension Safety Set: defined as the subset of the patients from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Absence of All Ocular Structural Abnormalities at or Before the Participant's Fifth Birthday Visit | at or before the participant's fifth birthday visit (up to maximum 5 years and 4 months post core baseline visit) | Extension Safety Set: defined as the subset of the participants from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Absence of Individual Ocular Structural Abnormalities at or Before 40 Weeks Post Baseline Visit | at or before 40 weeks post baseline visit | Extension Safety Set: defined as the subset of the patients from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Absence of Individual Ocular Structural Abnormalities at or Before the Participant's Fifth Birthday Visit | at or before the participant's fifth birthday visit (up to maximum 5 years and 4 months post core baseline visit) | Extension Safety Set: defined as the subset of the participants from the Safety Set of the core study who entered the extension study and comprised data from both core and extension studies. The outcome measure included number of participants contributing to analysis. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group174
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Visual Acuity (VA) of the Better-seeing Eye at the Participant's Fifth Birthday Visit - Comparison Between Treatment Arms | Ranibizumab 0.2 mg | 66.8 | Standard Error 1.95 | Score on a scale | |
| Visual Acuity (VA) of the Better-seeing Eye at the Participant's Fifth Birthday Visit - Comparison Between Treatment Arms | Ranibizumab 0.1 mg | 64.6 | Standard Error 2.00 | Score on a scale | |
| Visual Acuity (VA) of the Better-seeing Eye at the Participant's Fifth Birthday Visit - Comparison Between Treatment Arms | Laser Therapy | 62.1 | Standard Error 2.18 | Score on a scale | |
| Number of Participants With Ocular Adverse Events (AEs) Regardless of Study Treatment or Procedure Relationship by Preferred Term | Ranibizumab 0.2 mg | 19 | Participants | ||
| Number of Participants With Ocular Adverse Events (AEs) Regardless of Study Treatment or Procedure Relationship by Preferred Term | Ranibizumab 0.1 mg | 26 | Participants | ||
| Number of Participants With Ocular Adverse Events (AEs) Regardless of Study Treatment or Procedure Relationship by Preferred Term | Laser Therapy | 22 | Participants | ||
| 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 | Ranibizumab 0.2 mg | 46 | Participants | ||
| 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 | Ranibizumab 0.1 mg | 53 | Participants | ||
| 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 | Laser Therapy | 46 | Participants | ||
| Visual Acuity (VA) of the Worse-seeing Eye at the Participant's Fifth Birthday Visit - Comparison Between Treatment Arms | Ranibizumab 0.2 mg | 60.2 | Standard Error 2.95 | Score on a scale |
1 to 10 of 174Source ClinicalTrials.gov
See all 174 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Epoch 1 | STARTED | Ranibizumab 0.2 mg | 61 | |
| Epoch 1 | STARTED | Ranibizumab 0.1 mg | 65 | |
| Epoch 1 | STARTED | Laser Therapy | 54 | |
| Epoch 1 | COMPLETED | Ranibizumab 0.2 mg | 60 | |
| Epoch 1 | COMPLETED | Ranibizumab 0.1 mg | 65 | |
| Epoch 1 | COMPLETED | Laser Therapy | 53 | |
| Epoch 1 | NOT COMPLETED | Ranibizumab 0.2 mg | 1 | |
| Epoch 1 | NOT COMPLETED | Ranibizumab 0.1 mg | 0 | |
| Epoch 1 | NOT COMPLETED | Laser Therapy | 1 | |
| Epoch 2 | STARTED | Ranibizumab 0.2 mg | 60 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events668
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 | Astigmatism | Eye disorders | Ranibizumab 0.2 mg | 3 | 61 | |
| other | Astigmatism | Eye disorders | Ranibizumab 0.1 mg | 2 | 65 | |
| other | Astigmatism | Eye disorders | Laser Therapy | 2 | 54 | |
| other | Astigmatism | Eye disorders | Total | 7 | 180 | |
| other | Myopia | Eye disorders | Ranibizumab 0.2 mg | 6 | 61 | |
| other | Myopia | Eye disorders | Ranibizumab 0.1 mg | 3 | 65 | |
| other | Myopia | Eye disorders | Laser Therapy | 5 | 54 | |
| other | Myopia | Eye disorders | Total | 14 | 180 | |
| other | Strabismus | Eye disorders | Ranibizumab 0.2 mg | 10 | 61 | |
| other | Strabismus | Eye disorders | Ranibizumab 0.1 mg | 12 | 65 |
1 to 10 of 668Source ClinicalTrials.gov
See all 668 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ranibizumab 0.2 mg | 0 | 61 |
| Total, all-cause mortality | Ranibizumab 0.1 mg | 0 | 65 |
| Total, all-cause mortality | Laser Therapy | 2 | 54 |
| Total, all-cause mortality | Total | 2 | 180 |
| Total, other adverse events | Ranibizumab 0.2 mg | 41 | 61 |
| Total, other adverse events | Ranibizumab 0.1 mg | 46 | 65 |
| Total, other adverse events | Laser Therapy | 40 | 54 |
| Total, other adverse events | Total | 127 | 180 |
| Total, serious adverse events | Ranibizumab 0.2 mg | 21 | 61 |
| Total, serious adverse events | Ranibizumab 0.1 mg | 27 | 65 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02640664
GET https://conductscience.org/api/trials/v1/NCT02640664/registered?page=2