Trial · NCT02640664
Outcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| 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 |
| SECONDARY | Number of Participants With Absence of All Ocular Structural Abnormalities at or Before Participant's 2 Years Corrected Age Visit | at or before participant's 2 years corrected age visit (up to 2 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 Participant's 2 Years Corrected Age Visit | at or before participant's 2 years corrected age visit (up to 2 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 Recurrence of ROP up to 40 Weeks Post Baseline Visit in the Core Study | up to 40 weeks post baseline visit in the core study | 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 Recurrence of ROP up to 52 Weeks Post Baseline Visit in the Core Study | up to 52 weeks post baseline visit in the core study | 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 Ranibizumab Injections Received Per Participant Over the Whole Safety Observation Period | up to and including 40 weeks post baseline visit in the core study | 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. | Number of injections | MEAN |
| SECONDARY | Refraction Status: Summary of Participants at Participant's 2 Years Corrected Age | at participant's 2 years corrected age (maximum 2 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. | diopters | MEAN |
| SECONDARY | Refraction Status: Summary of Participants at the Participant's Fifth Birthday Visit | 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. | diopters | MEAN |
| SECONDARY | Change From Baseline in Weight | Baseline of the core study, at the subject's 2 years' corrected age (maximum 2 years and 4 months post core baseline visit) and at the subjects' fifth birthday (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. 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. | grams | MEAN |
| SECONDARY | Change From Baseline in Head Circumference | Baseline of the core study and at the subject's 2 years' corrected age (maximum 2 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. | cm | MEAN |
| SECONDARY | Change From Baseline in Sitting Diastolic Blood Pressure | Baseline of the core study and at the subject's 2 years' corrected age (maximum 2 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. | mmHg | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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