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This is a 24-week, multicenter, open-label, single-arm, observational, post approval commitment study, which is designed to collect effectiveness, safety and other clinical information of intravitreal ranibizumab 0.2 mg for the treatment of Retinopathy of Prematurity (ROP) participants in a real world clinical setting in mainland China.
Eligible participants treated according to local routine clinical practice will be enrolled in the study upon signing an Informed Consent.
Participants will enter the study when they receive their first treatment and are followed up for 24 weeks. During the follow up period, participants could receive post-baseline treatment (i.e., ranibizumab or laser therapy) Patients will be treated according to the approved label and standard of care and as per Investigator judgement.
End of study will be defined as completion of the week 24 visit or premature withdrawal visit
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ranibizumab 0.2 mg | Intravitreal ranibizumab 0.2 mg for the treatment of ROP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Other | Prospective observational study. There is no treatment allocation. Patients prescribed with ranibizumab 0.2 mg in the commercial setting are eligible to enroll into this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with absence of active Retinopathy of Prematurity (ROP) and absence of unfavorable structural outcomes in both eyes during the observational period after starting study treatment. | To achieve this outcome, participants cannot fulfill any of the following criteria:
| Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AEs | Incidence of AEs will be collected | Up to 24 weeks |
| Assessment of length | For the assessment of length the participant should be wearing minimal clothing (e.g., a clean diaper). Recumbent length in centimeters will be measured using an infantometer or according to local clinical practice. |
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Inclusion Criteria:
Signed informed consent from parent(s) or legal guardian(s), in compliance with local requirements
Male or female preterm infants with a birth weight of less than 1500 g
Bilateral ROP with 1 of the following retinal findings in each eye:
Exclusion Criteria:
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Male and female preterm infants with confirmed diagnosis of bilateral ROP who require treatment in China
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Guangzhou | Guangdong | 510000 | China |
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| Label | URL |
|---|---|
| Results for CRFB002H2403 from the Novartis Clinical Trials Website | View source |
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| ID | Term |
|---|---|
| D012178 | Retinopathy of Prematurity |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Baseline, Week 12, and Week 24 |
| Assessment of weight | For the assessment of weight the participant should be wearing minimal clothing (e.g., a clean diaper). Body weight to the nearest gram will be measured using an electronic scale. | Baseline, Week 12, and Week 24 |
| Assessment of head circumference | For the assessment of head circumference the participant should be wearing minimal clothing (e.g., a clean diaper). The maximum occipitofrontal head circumference in centimeters will be measured using a tape measure. | Baseline, Week 12, and Week 24 |
| Assessment of lower leg length | For the assessment of lower leg length the participant should be wearing minimal clothing (e.g., a clean diaper).The lower leg length (knee-heel length) will be measured to the nearest 0.1 centimeter using a sliding caliper or according to local clinical practice. Measurements should always be done on the right side, unless a physical deformity affects the right side. | Baseline, Week 12, and Week 24 |
| Time to intervention with a second modality for ROP or development of unfavorable structural outcome | Time to intervention with a second modality for ROP or development of unfavorable structural outcome will be collected | Up to 24 weeks |
| Proportion of participants with re-treatment of ROP receiving any post-baseline intervention | Proportion of participants with re-treatment of ROP receiving any post-baseline intervention at or before 24 weeks | 24 weeks |
| number of ranibizumab administrations needed in the treatment of participants with ROP | number of ranibizumab administrations needed in the treatment of participants with ROP will be collected | 24 weeks |
| Full retinal vascularization in 12 clock hours | Full retinal vascularization in 12 clock hours at the 24-week assessment to evaluate fundus features of ranibizumab 0.2 mg in the treatment of ROP | Week 24 |
| D009358 |
| Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |