Study Description
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. 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.
Interventions
Lucentis
Eligibility Criteria
Inclusion Criteria:
1. Premature infants with retinopathy of prematurity (ROP)
2. Patients (infants) prescribed with Lucentis® injection according to the product
approval information in the Republic of Korea
3. In the case that the legal guardian of the patient (infant) provided a written
consent to participate in this study
Exclusion Criteria:
1. In the case that the legal guardian of the patient (infant) does not want
participation in this study
2. 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
Study Location
Novartis Investigative Site
Recruiting
Daegu,Dalseo Gu,42602,Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul,06351,Korea, Republic of
Worldwide Contacts
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