NCT05304949

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 69 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 0 Years – 10 Years
• Healthy volunteers: Not accepted

Summary

This study was 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 collected safety information and evaluated effectiveness in patients who were 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 were defined as subjects with long-term use, and the safety and effectiveness information of up to 12 weeks was collected and analyzed separately.

Conditions

• Retinopathy of Prematurity

Interventions

Type	Name	Description
OTHER	Lucentis	There was no treatment allocation. Patients administered Lucentis by prescription were enrolled.

Timeline

• Start date: 2022-06-22
• Primary completion: 2025-01-11
• Completion: 2025-01-11
• First posted: 2022-03-31
• Last updated: 2025-07-04

Locations

6 sites across 1 country: South Korea