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

NCT05304949 | Completed

• 1 other identifier: CRFB002HKR01
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Retinopathy of Prematurity

Keywords

Retinopathy of Prematurity; NIS; Post-Marketing Surveillance; Lucentis; Ranibizumab; Korea

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events/adverse drug reactions

  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

  Up to 12 weeks

Secondary Outcomes (1)

• Proportion of treatment success

  Up to 12 weeks

Study Arms (1)

Lucentis

Patients prescribed with Lucentis

Other: Lucentis

Interventions

Lucentis OTHER

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

Also known as: Ranibizumab

Lucentis

Eligibility Criteria

• Age: 0 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Korean patients who are prescribed with Lucentis® (Ranibizumab) injection in ROP indication

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (6)

Novartis Investigative Site

Daegu, Dalseo gu, 42602, South Korea

Location

Novartis Investigative Site

Bundang Gu, Gyeonggi-do, 13620, South Korea

Location

Novartis Investigative Site

Seoul, 03722, South Korea

Location

Novartis Investigative Site

Seoul, 05505, South Korea

Location

Novartis Investigative Site

Seoul, 06273, South Korea

Location

Novartis Investigative Site

Seoul, 06351, South Korea

Location

Related Links

• Results for CRFB002HKR01 from the Novartis Clinical Trial Results Website

MeSH Terms

Conditions

Retinopathy of Prematurity

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 31, 2022
• Study Start: June 22, 2022
• Primary Completion: January 11, 2025
• Study Completion: January 11, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (6)