Regulatory Post-Marketing Surveillance(PMS) Study for Lucentis®(Ranibizumab) in Patients With Retinopathy of Prematurity
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Retinopathy of Prematurity
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- Incidence of adverse events/adverse drug reactions
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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 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.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
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 were collected
Secondary Outcomes
- Proportion of treatment success(Up to 12 weeks)