Retinopathy of Prematurity
Conditions
Keywords
Retinopathy of Prematurity, NIS, Post-Marketing Surveillance, Lucentis, Ranibizumab, Korea
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.
Interventions
OTHERLucentis
There was no treatment allocation. Patients administered Lucentis by prescription were enrolled.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
1. Premature infants with retinopathy of prematurity (ROP) 2. Patients (infants) prescribed with Lucentis® injection according to the product approval information in the Republic of Korea 3. In the case that the legal guardian of the patient (infant) provided a written consent to participate in this study
Exclusion criteria
1. In the case that the legal guardian of the patient (infant) does not want participation in this study 2. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events/adverse drug reactions | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of treatment success | 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 |
Countries
South Korea
Outcome results
None listed