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.
The investigators collected safety information and evaluated effectiveness in patients who were 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 were defined as subjects with long-term use, and the safety and effectiveness information of up to 12 weeks was collected and analyzed separately.
Study Type
OBSERVATIONAL
Enrollment
69
There was no treatment allocation. Patients administered Lucentis by prescription were enrolled.
Novartis Investigative Site
Daegu, Dalseo gu, South Korea
Novartis Investigative Site
Bundang Gu, Gyeonggi-do, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Incidence of adverse events/adverse drug reactions
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 were collected
Time frame: Up to 12 weeks
Proportion of treatment success
Proportion of treatment success, defined as regression of proliferative phase and/or complete peripheral retinal vascularization as assessed by the investigator
Time frame: Up to 12 weeks
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Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea