Regulatory PMS Study for Lucentis® in Patients With Retinopathy of Prematurity

Regulatory Post-Marketing Surveillance(PMS) Study for Lucentis®(Ranibizumab) in Patients With Retinopathy of Prematurity

ClinicalTrials.gov Identifier: NCT05304949

Novartis Reference Number: CRFB002HKR01

Last Update: Sep 16, 2022

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This study is an open-labeled, multicenter, single arm, observational post-marketing surveillance study under routine clinical practice with no mandated treatments, visits or assessments.

Condition 
Retinopathy of Prematurity
Phase 
Not Given
Overall status 
Recruiting
Start date 
Jun 22, 2022
Completion date 
Jan 12, 2025
Gender 
All
Age(s)
10 Years and older (Child)

Interventions

Other
Lucentis
There is no treatment allocation. Patients administered Lucentis by prescription will be enrolled.

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

Study Locations

Korea, Republic of
Novartis Investigative Site
Recruiting
Daegu, 42602
Dalseo Gu
Korea, Republic of

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]