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

Recruiting

• Conditions: Retinopathy of Prematurity
• Interventions: Other: Lucentis

• Registration Number: NCT05304949
• Lead Sponsor: 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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-31
• Study Start: 2022-06-22
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-05
• Primary Completion: 2025-01-12
• Study Completion: 2025-01-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lucentis	Lucentis	Patients prescribed with Lucentis

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇰🇷 Seoul, Korea, Republic of