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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
Novartis Pharmaceuticals·ClinicalTrials.gov·otherRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Retinopathy of Prematurity
Drug/Device/Intervention
Ranibizumab
Study type
Observational
Intervention type
other
Sponsor & location
Primary sponsor
Novartis Pharmaceuticals
Funder
Novartis
Location
Chengdu,Hangzhou,Shanghai, China
Timeline & enrollment
Phase
N/A
Start date
Jan 13, 2023
End date
May 16, 2024
Enrollment
55 participants
Primary outcome

Number of participants with absence of active Retinopathy of Prematurity (ROP) and absence of unfavorable structural outcomes in both eyes during the observational period after starting study treatment.

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.

ICD-10 classifications
Retinopathy of prematurityOther proliferative retinopathyBackground retinopathy and retinal vascular changesDiabetic retinopathyRetinal disorder, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05576792
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05576792 through Pure Global AI's free database. This phase not specified trial is sponsored by Novartis Pharmaceuticals and is currently Recruiting. The study focuses on Retinopathy of Prematurity. Target enrollment is 55 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.