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

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

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.

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