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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05304949

Collaborator

(none)

Enrollment

29.5

Anticipated Duration (Months)

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
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.

Study Design

Study Type:

Observational

Anticipated 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

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
Lucentis Patients prescribed with Lucentis	Other: Lucentis There is no treatment allocation. Patients administered Lucentis by prescription will be enrolled. Other Names: Ranibizumab

Arm

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

Outcome Measures

Primary Outcome Measures

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

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

Criteria

Ages Eligible for Study:

N/A to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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