Regulatory PMS Study for Lucentis® in Patients With Retinopathy of Prematurity
Study Details
Study Description
Brief Summary
This study is an open-labeled, multicenter, single arm, observational post-marketing surveillance study under routine clinical practice with no mandated treatments, visits or assessments.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
The investigators will collect safety information and evaluate effectiveness in patients who are 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 will be defined as subjects with long-term use, and the safety and effectiveness information of up to 12 weeks will be collected and analyzed separately.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Lucentis Patients prescribed with Lucentis |
Other: Lucentis
There is no treatment allocation. Patients administered Lucentis by prescription will be enrolled.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Incidence of adverse events/adverse drug reactions [Up to 12 weeks]
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 will be collected
Secondary Outcome Measures
- Proportion of treatment success [Up to 12 weeks]
Proportion of treatment success, defined as regression of proliferative phase and/or complete peripheral retinal vascularization as assessed by the investigator
Eligibility Criteria
Criteria
Inclusion Criteria:
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Premature infants with retinopathy of prematurity (ROP)
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Patients (infants) prescribed with Lucentis® injection according to the product approval information in the Republic of Korea
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In the case that the legal guardian of the patient (infant) provided a written consent to participate in this study
Exclusion Criteria:
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In the case that the legal guardian of the patient (infant) does not want participation in this study
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In the case that it falls under any of the contraindications listed in local prescribing information of Lucentis® injection
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Patients with hypersensitivity to the active substance or to any of the excipients
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Patients with an active or suspected ocular or periocular infection.
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Patients with active intraocular inflammation
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRFB002HKR01