Regulatory PMS Study for Lucentis® in Patients With Retinopathy of Prematurity
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|ClinicalTrials.gov Identifier: NCT05304949|
Recruitment Status : Recruiting
First Posted : March 31, 2022
Last Update Posted : September 16, 2022
|Condition or disease||Intervention/treatment|
|Retinopathy of Prematurity||Other: Lucentis|
The investigators will collect safety information and evaluate effectiveness in patients who are prescribed with Lucentis® (Ranibizumab) injection in Retinopathy of Prematurity indication after receiving informed consent over a period of 4 weeks.
Subjects who received multiple doses, i.e., 2 or more doses, of Lucentis® injection will be defined as subjects with long-term use, and the safety and effectiveness information of up to 12 weeks will be collected and analyzed separately.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Regulatory Post-Marketing Surveillance(PMS) Study for Lucentis®(Ranibizumab) in Patients With Retinopathy of Prematurity|
|Actual Study Start Date :||June 22, 2022|
|Estimated Primary Completion Date :||January 12, 2025|
|Estimated Study Completion Date :||January 12, 2025|
Patients prescribed with Lucentis
There is no treatment allocation. Patients administered Lucentis by prescription will be enrolled.
Other Name: Ranibizumab
- Incidence of adverse events/adverse drug reactions [ Time Frame: Up to 12 weeks ]Incidence of adverse events/adverse drug reactions, serious adverse events/adverse drug reactions, unexpected adverse events/adverse drug reactions, suspected unexpected serious adverse reactions/adverse drug reactions will be collected
- Proportion of treatment success [ Time Frame: Up to 12 weeks ]Proportion of treatment success, defined as regression of proliferative phase and/or complete peripheral retinal vascularization as assessed by the investigator
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05304949
|Contact: Novartis Pharmaceuticalsfirstname.lastname@example.org|
|Contact: Novartis Pharmaceuticals|
|Korea, Republic of|
|Novartis Investigative Site||Recruiting|
|Daegu, Dalseo Gu, Korea, Republic of, 42602|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|