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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05576792
Study type Observational
Source Novartis
Contact Novartis Pharmaceuticals
Phone +41613241111
Email novartis.email@novartis.com
Status Recruiting
Phase
Start date January 13, 2023
Completion date December 30, 2024

See also
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