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

Last updated: February 6, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

N/A

Condition

Retina

Myopic Macular Degeneration

Treatment

Lucentis

Clinical Study ID

NCT05304949
CRFB002HKR01
  • Ages < 10
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Premature infants with retinopathy of prematurity (ROP)

  2. Patients (infants) prescribed with Lucentis® injection according to the productapproval information in the Republic of Korea

  3. In the case that the legal guardian of the patient (infant) provided a writtenconsent to participate in this study

Exclusion

Exclusion Criteria:

  1. In the case that the legal guardian of the patient (infant) does not wantparticipation in this study

  2. In the case that it falls under any of the contraindications listed in localprescribing information of Lucentis® injection

  • Patients with hypersensitivity to the active substance or to any of theexcipients

  • Patients with an active or suspected ocular or periocular infection.

  • Patients with active intraocular inflammation

Study Design

Total Participants: 71
Treatment Group(s): 1
Primary Treatment: Lucentis
Phase:
Study Start date:
June 22, 2022
Estimated Completion Date:
January 11, 2025

Study Description

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.

Connect with a study center

  • Novartis Investigative Site

    Daegu, Dalseo Gu 42602
    Korea, Republic of

    Site Not Available

  • Novartis Investigative Site

    Seoul, 06351
    Korea, Republic of

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.