Regulatory PMS Study for Lucentis® 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.

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Key information

Conditions

Retinopathy of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Retinal Diseases

Age range

0 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Daegu, Dalseo gu, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Lucentis

Other

There was no treatment allocation. Patients administered Lucentis by prescription were enrolled.

Other names: Ranibizumab

Primary outcomes

Incidence of adverse events/adverse drug reactions

Time frame: Up to 12 weeks

Incidence of adverse events/adverse drug reactions, serious adverse events/adverse drug reactions, unexpected adverse events/adverse drug reactions, suspected unexpected serious adverse reactions/adverse drug reactions were collected

Secondary outcomes

Proportion of treatment success

Time frame: Up to 12 weeks

Proportion of treatment success, defined as regression of proliferative phase and/or complete peripheral retinal vascularization as assessed by the investigator

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2025
First posted: Mar 31, 2022
Registry last updated: Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed