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This study was an open-labeled, multicenter, single arm, observational post-marketing surveillance study under routine clinical practice with no mandated treatments, visits or assessments.
The investigators collected safety information and evaluated effectiveness in patients who were prescribed with Lucentis® (Ranibizumab) injection in Retinopathy of Prematurity indication after receiving informed consent over a period of 4 weeks.
Subjects who received multiple doses, i.e., 2 or more doses, of Lucentis® injection were defined as subjects with long-term use, and the safety and effectiveness information of up to 12 weeks was collected and analyzed separately.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lucentis | Patients prescribed with Lucentis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lucentis | Other | There was no treatment allocation. Patients administered Lucentis by prescription were enrolled. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events/adverse drug reactions | Incidence of adverse events/adverse drug reactions, serious adverse events/adverse drug reactions, unexpected adverse events/adverse drug reactions, suspected unexpected serious adverse reactions/adverse drug reactions were collected | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of treatment success | Proportion of treatment success, defined as regression of proliferative phase and/or complete peripheral retinal vascularization as assessed by the investigator | Up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
In the case that the legal guardian of the patient (infant) does not want participation in this study
In the case that it falls under any of the contraindications listed in local prescribing information of Lucentis® injection
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Korean patients who are prescribed with Lucentis® (Ranibizumab) injection in ROP indication
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Daegu | Dalseo gu | 42602 | South Korea | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CRFB002HKR01 from the Novartis Clinical Trial Results 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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| Bundang Gu |
| Gyeonggi-do |
| 13620 |
| South Korea |
| Novartis Investigative Site | Seoul | 03722 | South Korea |
| Novartis Investigative Site | Seoul | 05505 | South Korea |
| Novartis Investigative Site | Seoul | 06273 | South Korea |
| Novartis Investigative Site | Seoul | 06351 | South Korea |
| 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 |