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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-22

Study Completion Date

2025-01-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A 24-week Study Evaluating the Effectiveness and Safety of Lucentis® 0.2mg in Retinopathy of Prematurity Participants in China

NCT05576792

Retinopathy of Prematurity

COMPLETED

Study To Determine Safety/Efficacy of Lucentis For Treatment Of Retinal Angiomatous Proliferation Secondary To Age Related Macular Degeneration

NCT00395707

Macular Degeneration

COMPLETED PHASE1/PHASE2

Ranibizumab Short- and Log-term Effects on Retinal Function in wAMD

NCT01269151

COMPLETED NA

Observation of Treatment Patterns With Lucentis® in Real-life Conditions in All Approved Indications

NCT04847895

Neovascular (Wet) Age-related Macular Degeneration

COMPLETED

Efficacy and Safety of Lucentis® Use in Patients With Diabetic Macular Edema Evaluating a Spaced Out Follow-up After Intensive Treatment Phase

NCT02032173

Macular Edema Macular Degeneration Diabetes

TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retinopathy of Prematurity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lucentis

Patients prescribed with Lucentis

Lucentis

Intervention Type OTHER

There was no treatment allocation. Patients administered Lucentis by prescription were enrolled.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lucentis

There was no treatment allocation. Patients administered Lucentis by prescription were enrolled.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ranibizumab

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

0 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No