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A 24-week Study Evaluating the Effectiveness and Safety of Lucentis® 0.2mg in Retinopathy of Prematurity Participants in China - Trial NCT05576792

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.

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NCT05576792
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Trial Details
ClinicalTrials.govNCT05576792
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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

Study Focus

Ranibizumab

Observational

other

Sponsor & Location

Novartis Pharmaceuticals

Novartis

Chengdu,Hangzhou,Shanghai, China

Timeline & Enrollment

N/A

Jan 13, 2023

May 16, 2024

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 prematurity
Other proliferative retinopathy
Background retinopathy and retinal vascular changes
Diabetic retinopathy
Retinal disorder, unspecified

Data Source

ClinicalTrials.gov

NCT05576792

Non-Device Trial