Novartis Investigative Site
Guangzhou, Guangdong, 510000, China
NCT Number: NCT05576792
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.
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All sexes
Observational
Guangzhou, Guangdong, 510000, China
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Week 24
To achieve this outcome, participants cannot fulfill any of the following criteria:
Time frame: Up to 24 weeks
Incidence of AEs will be collected
Time frame: Baseline, Week 12, and Week 24
For the assessment of length the participant should be wearing minimal clothing (e.g., a clean diaper). Recumbent length in centimeters will be measured using an infantometer or according to local clinical practice.
Time frame: Baseline, Week 12, and Week 24
For the assessment of weight the participant should be wearing minimal clothing (e.g., a clean diaper). Body weight to the nearest gram will be measured using an electronic scale.
Time frame: Baseline, Week 12, and Week 24
For the assessment of head circumference the participant should be wearing minimal clothing (e.g., a clean diaper). The maximum occipitofrontal head circumference in centimeters will be measured using a tape measure.
Time frame: Baseline, Week 12, and Week 24
For the assessment of lower leg length the participant should be wearing minimal clothing (e.g., a clean diaper).The lower leg length (knee-heel length) will be measured to the nearest 0.1 centimeter using a sliding caliper or according to local clinical practice. Measurements should always be done on the right side, unless a physical deformity affects the right side.
Time frame: Up to 24 weeks
Time to intervention with a second modality for ROP or development of unfavorable structural outcome will be collected
Time frame: 24 weeks
Proportion of participants with re-treatment of ROP receiving any post-baseline intervention at or before 24 weeks
Time frame: 24 weeks
number of ranibizumab administrations needed in the treatment of participants with ROP will be collected
Time frame: Week 24
Full retinal vascularization in 12 clock hours at the 24-week assessment to evaluate fundus features of ranibizumab 0.2 mg in the treatment of ROP
Novartis Pharmaceuticals
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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