NCT05576792

A 24-week Study Evaluating the Effectiveness and Safety of Lucentis® 0.2mg in Retinopathy of Prematurity Participants in China

A 24-week, Open-label, Prospective, Single-arm Study Evaluating the Effectiveness and Safety of Lucentis® (Ranibizumab) 0.2mg in Retinopathy of Prematurity (ROP) Participants in China

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 62 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 0 Days
• Healthy volunteers: Not accepted

Summary

This is a 24-week, multicenter, open-label, single-arm, observational, post approval commitment study, which is designed to collect effectiveness, safety and other clinical information of intravitreal ranibizumab 0.2 mg for the treatment of Retinopathy of Prematurity (ROP) participants in a real world clinical setting in mainland China.

Detailed description

Eligible participants treated according to local routine clinical practice will be enrolled in the study upon signing an Informed Consent. Participants will enter the study when they receive their first treatment and are followed up for 24 weeks. During the follow up period, participants could receive post-baseline treatment (i.e., ranibizumab or laser therapy) Patients will be treated according to the approved label and standard of care and as per Investigator judgement. End of study will be defined as completion of the week 24 visit or premature withdrawal visit

Conditions

• Retinopathy of Prematurity

Interventions

Type	Name	Description
OTHER	Ranibizumab	Prospective observational study. There is no treatment allocation. Patients prescribed with ranibizumab 0.2 mg in the commercial setting are eligible to enroll into this study.

Timeline

• Start date: 2023-01-13
• Primary completion: 2024-07-10
• Completion: 2024-07-10
• First posted: 2022-10-13
• Last updated: 2025-03-25

Locations

1 site across 1 country: China