Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Visual Acuity (VA) of the Better-seeing Eye at the Participant's Fifth Birthday Visit - Comparison Between Treatment Arms |
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. |
at the participant's fifth birthday visit (maximum 5 years and 4 months post core baseline visit) |
|
| Secondary |
Number of Participants With Ocular Adverse Events (AEs) Regardless of Study Treatment or Procedure Relationship by Preferred Term |
Number of participants with ocular AEs starting during the core study and ongoing at extension baseline, or starting on/after extension baseline were reported. |
throughout the study, approximately 5 years |
|
| 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 |
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. |
throughout the study, approximately 5 years |
|
| Secondary |
Visual Acuity (VA) of the Worse-seeing Eye at the Participant's Fifth Birthday Visit - Comparison Between Treatment Arms |
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. |
at the participant's fifth birthday visit (maximum 5 years and 4 months post core baseline visit) |
|
| Secondary |
Number of Participants With Absence of Active Retinopathy of Prematurity (ROP) 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. |
at 40 weeks post core baseline visit |
|
| Secondary |
Number of Participants With Absence of Active Retinopathy of Prematurity (ROP) 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. |
at 52 weeks post core baseline visit |
|
| Secondary |
Number of Participants With Absence of All Ocular Structural Abnormalities 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 |
at or before 40 weeks post baseline visit |
|
| Secondary |
Number of Participants With Absence of All Ocular Structural Abnormalities at or Before the Participant's Fifth Birthday 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 |
at or before the participant's fifth birthday visit (up to maximum 5 years and 4 months post core baseline visit) |
|
| Secondary |
Number of Participants With Absence of Individual Ocular Structural Abnormalities 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 |
at or before 40 weeks post baseline visit |
|
| Secondary |
Number of Participants With Absence of Individual Ocular Structural Abnormalities at or Before the Participant's Fifth Birthday 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 |
at or before the participant's fifth birthday visit (up to maximum 5 years and 4 months post core baseline visit) |
|
| Secondary |
Number of Participants With Absence of All Ocular Structural Abnormalities at or Before Participant's 2 Years Corrected Age 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 |
at or before participant's 2 years corrected age visit (up to 2 years and 4 months post core baseline visit) |
|
| Secondary |
Number of Participants With Absence of Individual Ocular Structural Abnormalities at or Before Participant's 2 Years Corrected Age 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 |
at or before participant's 2 years corrected age visit (up to 2 years and 4 months post core baseline visit) |
|
| Secondary |
Number of Participants With Recurrence of ROP up to 40 Weeks Post Baseline Visit in the Core Study |
Recurrence of ROP was defined as ROP receiving any post-baseline intervention after the 1st study treatment in the core study. In the ranibizumab arms, post-baseline interventions were ranibizumab retreatment or switch to laser. In the laser arm, post-baseline interventions were supplementary laser treatments after 11 days post-baseline, or switch to ranibizumab; supplementary laser treatment within 11 days post-baseline was not counted as recurrence. |
up to 40 weeks post baseline visit in the core study |
|
| Secondary |
Number of Participants With Recurrence of ROP up to 52 Weeks Post Baseline Visit in the Core Study |
Recurrence of ROP was defined as ROP receiving any post-baseline intervention after the 1st study treatment in the core study. In the ranibizumab arms, post-baseline interventions were ranibizumab retreatment or switch to laser. In the laser arm, post-baseline interventions were supplementary laser treatments after 11 days post-baseline, or switch to ranibizumab; supplementary laser treatment within 11 days post-baseline was not counted as recurrence. Beyond Week 40, participants did not receive any study intervention and no new data was collected after 40 weeks post core baseline visit. |
up to 52 weeks post baseline visit in the core study |
|
| Secondary |
Number of Ranibizumab Injections Received Per Participant Over the Whole Safety Observation Period |
Number of ranibizumab injections received in the treatment of participants with ROP up to and including 40 weeks post baseline visit in the core study were reported. |
up to and including 40 weeks post baseline visit in the core study |
|
| Secondary |
Refraction Status: Summary of Participants at Participant's 2 Years Corrected Age |
Summary of participants was reported to evaluate the refraction in each eye at the participant's 2 years corrected age |
at participant's 2 years corrected age (maximum 2 years and 4 months post core baseline visit) |
|
| Secondary |
Refraction Status: Summary of Participants at the Participant's Fifth Birthday Visit |
Summary of participants was reported to evaluate the refraction in each eye at the participant's 2 years' corrected age |
at the participant's fifth birthday visit (maximum 5 years and 4 months post core baseline visit) |
|
| Secondary |
Change From Baseline in Weight |
Subject´s weight was reported to evaluate the physical development. |
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) |
|
| Secondary |
Change From Baseline in Head Circumference |
Subject´s head circumference was reported to evaluate the physical development. |
Baseline of the core study and at the subject's 2 years' corrected age (maximum 2 years and 4 months post core baseline visit) |
|
| Secondary |
Change From Baseline in Sitting Diastolic Blood Pressure |
Subject´s Sitting Diastolic Blood Pressure was reported to evaluate the physical development. |
Baseline of the core study and at the subject's 2 years' corrected age (maximum 2 years and 4 months post core baseline visit) |
|
| Secondary |
Change From Baseline in Sitting Systolic Blood Pressure |
Subject´s Sitting Systolic Blood Pressure was reported to evaluate the physical development. |
Baseline of the core study and at the subject's 2 years' corrected age (maximum 2 years and 4 months post core baseline visit) |
|
| Secondary |
Number of Participants With the Summary of Respiratory Function Status |
Number of participants with respiratory function status was reported |
at the participants' fifth birthday visit (maximum 5 years and 4 months post core baseline visit) |
|
| Secondary |
Number of Participants With Hearing Impairment of Any Type |
Number of participants with hearing function status was reported |
at the participants' fifth birthday visit (maximum 5 years and 4 months post core baseline visit) |
|
| Secondary |
Duration of Hospitalization |
Duration of hospitalization (from birth to first hospital discharge home) was reported to evaluate the health status of the subject |
From baseline of the core study up to 5 years and 4 months post core baseline visit |
|
| Secondary |
Weight at the Time of First Hospital Discharge |
Weight (gram) at the time of first hospital discharge was reported to evaluate the health status of the subject |
From baseline of the core study up to 5 years and 4 months post core baseline visit |
|
