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

Novartis Pharmaceuticals (Industry)
Overall Status
Not yet recruiting ID

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Lucentis

Detailed 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.

Study Design

Study Type:
Anticipated Enrollment :
60 participants
Observational Model:
Time Perspective:
Official Title:
Regulatory Post-Marketing Surveillance(PMS) Study for Lucentis®(Ranibizumab) in Patients With Retinopathy of Prematurity
Anticipated Study Start Date :
Jul 30, 2022
Anticipated Primary Completion Date :
Jan 12, 2025
Anticipated Study Completion Date :
Jan 12, 2025

Arms and Interventions

Arm Intervention/Treatment

Patients prescribed with Lucentis

Other: Lucentis
There is no treatment allocation. Patients administered Lucentis by prescription will be enrolled.
Other Names:
  • Ranibizumab
  • Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse events/adverse drug reactions [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 will be collected

    Secondary Outcome Measures

    1. Proportion of treatment success [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

    Eligibility Criteria


    Ages Eligible for Study:
    N/A to 10 Years
    Sexes Eligible for Study:
    Accepts 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

    Contacts and Locations


    No locations specified.

    Sponsors and Collaborators

    • Novartis Pharmaceuticals


    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Novartis Pharmaceuticals Identifier:
    Other Study ID Numbers:
    • CRFB002HKR01
    First Posted:
    Mar 31, 2022
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Keywords provided by Novartis Pharmaceuticals
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 30, 2022