CompletedNot Applicable

Regulatory PMS Study for Lucentis® in Patients With Retinopathy of Prematurity

South Korea69 participantsStarted 2022-06-22

Plain-language summary

This study was an open-labeled, multicenter, single arm, observational post-marketing surveillance study under routine clinical practice with no mandated treatments, visits or assessments.

Who can participate

Age range0 Years – 10 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

✕. 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

What they're measuring

Incidence of adverse events/adverse drug reactions

Timeframe: Up to 12 weeks

Trial details

NCT IDNCT05304949

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-01-11

View on ClinicalTrials.gov More Retinopathy of Prematurity trials