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

About the study

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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

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

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

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details

Contition

Retinopathy of Prematurity

Age (in years)

< 10

Participants needed

Est. Completion Date

Jan 12, 2025

Treatment type

Observational

Sponsor

Novartis

ClinicalTrials.gov identifier

NCT05304949

Study number

CRFB002HKR01

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