Status:
COMPLETED
Regulatory PMS Study for Lucentis® in Patients With Retinopathy of Prematurity
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Retinopathy of Prematurity
Eligibility:
All Genders
Up to 10 years
Brief 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.
Detailed Description
The investigators collected safety information and evaluated effectiveness in patients who were prescribed with Lucentis® (Ranibizumab) injection in Retinopathy of Prematurity indication after receivi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 22 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 11 2025
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT05304949
Start Date
June 22 2022
End Date
January 11 2025
Last Update
July 4 2025
Active Locations (6)
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1
Novartis Investigative Site
Daegu, Dalseo gu, South Korea, 42602
2
Novartis Investigative Site
Bundang Gu, Gyeonggi-do, South Korea, 13620
3
Novartis Investigative Site
Seoul, South Korea, 03722
4
Novartis Investigative Site
Seoul, South Korea, 05505