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

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ClinicalTrials.gov Identifier: NCT05304949
Recruitment Status : Recruiting
First Posted : March 31, 2022
Last Update Posted : September 16, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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
Retinopathy of Prematurity 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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Regulatory Post-Marketing Surveillance(PMS) Study for Lucentis®(Ranibizumab) in Patients With Retinopathy of Prematurity
Actual Study Start Date : June 22, 2022
Estimated Primary Completion Date : January 12, 2025
Estimated Study Completion Date : January 12, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

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 Name: Ranibizumab




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Korean patients who are prescribed with Lucentis® (Ranibizumab) injection in ROP indication
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05304949


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
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Korea, Republic of
Novartis Investigative Site Recruiting
Daegu, Dalseo Gu, Korea, Republic of, 42602
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05304949    
Other Study ID Numbers: CRFB002HKR01
First Posted: March 31, 2022    Key Record Dates
Last Update Posted: September 16, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Retinopathy of Prematurity
NIS
Post-Marketing Surveillance
Lucentis
Ranibizumab
Korea
Additional relevant MeSH terms:
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Retinal Diseases
Retinopathy of Prematurity
Premature Birth
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents