Regulatory PMS Study for Lucentis® in Patients With Retinopathy of Prematurity
About the study
This study is an open-labeled, multicenter, single arm, observational post-marketing surveillance study under routine clinical practice with no mandated treatments, visits or assessments.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Premature infants with retinopathy of prematurity (ROP)
- Patients (infants) prescribed with Lucentis® injection according to the product approval information in the Republic of Korea
- In the case that the legal guardian of the patient (infant) provided a written consent to participate in this study
EXCLUSION CRITERIA
Exclusion Criteria:
In the case that the legal guardian of the patient (infant) does not want participation in this study
In the case that it falls under any of the contraindications listed in local prescribing information of Lucentis® injection
- Patients with hypersensitivity to the active substance or to any of the excipients
- Patients with an active or suspected ocular or periocular infection.
- Patients with active intraocular inflammation
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Retinopathy of Prematurity
Age (in years)
< 10
Participants needed
60
Est. Completion Date
Jan 12, 2025
Treatment type
Observational
Sponsor
Novartis
ClinicalTrials.gov identifier
NCT05304949
Study number
CRFB002HKR01
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