Rainbow Extension Study

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.

Time frame: at the participant's fifth birthday visit (maximum 5 years and 4 months post core baseline visit)

Population: 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.

Subject´s head circumference was reported to evaluate the physical development.

Time frame: Baseline of the core study and at the subject's 2 years' corrected age (maximum 2 years and 4 months post core baseline visit)

Population: 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.

Subject´s Sitting Diastolic Blood Pressure was reported to evaluate the physical development.

Time frame: Baseline of the core study and at the subject's 2 years' corrected age (maximum 2 years and 4 months post core baseline visit)

Population: 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.

Subject´s Sitting Systolic Blood Pressure was reported to evaluate the physical development.

Time frame: Baseline of the core study and at the subject's 2 years' corrected age (maximum 2 years and 4 months post core baseline visit)

Population: 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.

Subject´s weight was reported to evaluate the physical development.

Time frame: 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)

Population: 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.

Duration of hospitalization (from birth to first hospital discharge home) was reported to evaluate the health status of the subject

Time frame: From baseline of the core study up to 5 years and 4 months post core baseline visit

Population: 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.

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.

Time frame: at 40 weeks post core baseline visit

Population: 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.

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.

Time frame: at 52 weeks post core baseline visit

Population: 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.

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

Time frame: at or before 40 weeks post baseline visit

Population: 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.

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

Time frame: at or before participant's 2 years corrected age visit (up to 2 years and 4 months post core baseline visit)

Population: 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.

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

Time frame: at or before the participant's fifth birthday visit (up to maximum 5 years and 4 months post core baseline visit)

Population: 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 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

Time frame: at or before 40 weeks post baseline visit

Population: 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.

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

Time frame: at or before participant's 2 years corrected age visit (up to 2 years and 4 months post core baseline visit)

Population: 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 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

Time frame: at or before the participant's fifth birthday visit (up to maximum 5 years and 4 months post core baseline visit)

Population: 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 participants with hearing function status was reported

Time frame: at the participants' fifth birthday visit (maximum 5 years and 4 months post core baseline visit)

Population: 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.

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.

Time frame: throughout the study, approximately 5 years

Population: 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.

Number of participants with ocular AEs starting during the core study and ongoing at extension baseline, or starting on/after extension baseline were reported.

Time frame: throughout the study, approximately 5 years

Population: 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.

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.

Time frame: up to 40 weeks post baseline visit in the core study

Population: 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.

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.

Time frame: up to 52 weeks post baseline visit in the core study

Population: 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.

Number of participants with respiratory function status was reported

Time frame: at the participants' fifth birthday visit (maximum 5 years and 4 months post core baseline visit)

Population: 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.

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.

Time frame: up to and including 40 weeks post baseline visit in the core study

Population: 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.

Summary of participants was reported to evaluate the refraction in each eye at the participant's 2 years corrected age

Time frame: at participant's 2 years corrected age (maximum 2 years and 4 months post core baseline visit)

Population: 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.

Summary of participants was reported to evaluate the refraction in each eye at the participant's 2 years' corrected age

Time frame: at the participant's fifth birthday visit (maximum 5 years and 4 months post core baseline visit)

Population: 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.

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.

Time frame: at the participant's fifth birthday visit (maximum 5 years and 4 months post core baseline visit)

Population: 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.

Weight (gram) at the time of first hospital discharge was reported to evaluate the health status of the subject

Time frame: From baseline of the core study up to 5 years and 4 months post core baseline visit

Population: 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.