Last Update: Jun 05, 2024
Regulatory Post-Marketing Surveillance(PMS) Study for Lucentis®(Ranibizumab) in Patients With Retinopathy of Prematurity
ClinicalTrials.gov Identifier:
Novartis Reference Number:CRFB002HKR01
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

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.

Retinopathy of Prematurity
Recruiting
60
Jun 22, 2022
Jan 12, 2025
All
- 10 Years (Child)

Interventions

Other

Lucentis

There is no treatment allocation. Patients administered Lucentis by prescription will be enrolled.

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

Worldwide Contacts

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Novartis Pharmaceuticals