Regulatory PMS Study for Lucentis® in Patients With Retinopathy of Prematurity

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Regulatory Post-Marketing Surveillance(PMS) Study for Lucentis®(Ranibizumab) in Patients With Retinopathy of Prematurity

Conditions
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Retinopathy of Prematurity

Intervention / Treatment
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* Other: Lucentis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Premature infants with retinopathy of prematurity (ROP) Patients (infants) prescribed with Lucentis® injection according to the product approval information in the Republic of Korea In the case that the legal guardian of the patient (infant) provided a written consent to participate in this study 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 Patients with hypersensitivity to the active substance or to any of the excipients Patients with an active or suspected ocular or periocular infection. Patients with active intraocular inflammation

Ages Eligible for Study
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Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lucentis<br>Patients prescribed with Lucentis | Other: Lucentis<br>* There is no treatment allocation. Patients administered Lucentis by prescription will be enrolled.<br>* Other names: Ranibizumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 will be collected | Up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retinopathy of Prematurity, NIS, Post-Marketing Surveillance, Lucentis, Ranibizumab, Korea