Retinopathy of PrematurityNCT05304949
Regulatory PMS Study for Lucentis® in Patients With Retinopathy of Prematurity
An observational study of Retinopathy of Prematurity, run by Novartis Pharmaceuticals at 6 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 10 years
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- Lucentis
- How many people
- 69 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 22 Jun 2022to 11 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Korean patients who are prescribed with Lucentis® (Ranibizumab) injection in ROP indication
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Novartis Investigative Site
Bundang Gu, Gyeonggi-do, 13620
Novartis Investigative Site
Daegu, Dalseo gu, 42602
Novartis Investigative Site
Seoul, 03722
Novartis Investigative Site
Seoul, 05505
Novartis Investigative Site
Seoul, 06273
Novartis Investigative Site
Seoul, 06351
About this study
Official title: Regulatory Post-Marketing Surveillance(PMS) Study for Lucentis®(Ranibizumab) in Patients With Retinopathy of Prematurity
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.
Read the 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.
- Conditions
- Retinopathy of Prematurity
- Being tested
- Lucentis
- Keywords
- Retinopathy of Prematurity, NIS, Post-Marketing Surveillance, Lucentis, Ranibizumab, Korea
- Medical subject headings
- Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LucentisOther
Also called Ranibizumab
There was no treatment allocation. Patients administered Lucentis by prescription were enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Lucentis | Patients prescribed with Lucentis Receives: Other: Lucentis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events/adverse drug reactions
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
Measured: Up to 12 weeks
Secondary outcomes (1)
Proportion of treatment success
Proportion of treatment success, defined as regression of proliferative phase and/or complete peripheral retinal vascularization as assessed by the investigator
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start22 Jun 2022
- Primary completion11 Jan 2025
- Study completion11 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304949
- Sponsor's protocol ID
- CRFB002HKR01
- Status last verified
- Jul 2025
- First submitted
- 22 Mar 2022
- Last updated
- 4 Jul 2025
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulatory Post-Marketing Surveillance(PMS) Study for Lucentis®(Ranibizumab) in Patients With Retinopathy of Prematurity
- ClinicalTrials.gov ID
- NCT05304949
- Acronym / sponsor ID
- CRFB002HKR01
- Conditions
- Retinopathy of Prematurity
- Keywords
- Retinopathy of Prematurity, NIS, Post-Marketing Surveillance, Lucentis, Ranibizumab, Korea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 11 Jan 2025 (actual)
- Study completion
- 11 Jan 2025 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lucentis | – | Other: LucentisPatients prescribed with Lucentis |
Who may qualify
- Ages
- 0 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Korean patients who are prescribed with Lucentis® (Ranibizumab) injection in ROP indication
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LucentisAlso: RanibizumabThere was no treatment allocation. Patients administered Lucentis by prescription were enrolled. | Other | Lucentis |
Primary outcome
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
1 secondary outcome
Proportion of treatment success
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Results for CRFB002HKR01 from the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinopathy of Prematurity, run by Novartis Pharmaceuticals at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events/adverse drug reactions (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.