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

May 29, 2023 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Novartis Investigative Site
    • Dalseo Gu
      • Daegu, Dalseo Gu, Korea, Republic of, 42602
        • Recruiting
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 10 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lucentis
Patients prescribed with Lucentis
Other: Lucentis
There is no treatment allocation. Patients administered Lucentis by prescription will be enrolled.
Other Names:
  • Ranibizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 will be collected
Up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2022

Primary Completion (Estimated)

January 12, 2025

Study Completion (Estimated)

January 12, 2025

Study Registration Dates

First Submitted

March 22, 2022

First Submitted That Met QC Criteria

March 22, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 29, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRFB002HKR01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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