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

Retinopathy of Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05304949
• Other study ID #: CRFB002HKR01
• Status: Recruiting
• Start date: June 22, 2022
• Est. completion date: January 12, 2025

Study information

• Verified date: June 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 12, 2025
• Est. primary completion date: January 12, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Novartis Investigative Site	Daegu	Dalseo Gu
Korea, Republic of	Novartis Investigative Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 will be collected	Up to 12 weeks
Secondary	Proportion of treatment success	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