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

Novartis

Status: Completed

Conditions: Retinopathy of Prematurity

Treatments: Other: Lucentis

Study type: Observational

Funder types: Industry

Identifiers

NCT05304949

CRFB002HKR01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 71 patients

Sex: All

Ages: Under 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

71 participants in 1 patient group

Lucentis

Description:

Patients prescribed with Lucentis

Treatment:

Other: Lucentis