Retinopathy of PrematurityNCT05576792
A 24-week Study Evaluating the Effectiveness and Safety of Lucentis® 0.2mg in Retinopathy of Prematurity Participants in China
An observational study of Retinopathy of Prematurity, run by Novartis Pharmaceuticals at 1 site in China.
Trial summary
This is a 24-week, multicenter, open-label, single-arm, observational, post approval commitment study, which is designed to collect effectiveness, safety and other clinical information of intravitreal ranibizumab 0.2 mg for the treatment of Retinopathy of Prematurity (ROP) participants in a real world clinical setting… Read more about this study
- Who is it for?
- Ages 0 days and older
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- Ranibizumab
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 13 Jan 2023to 10 Jul 2024
- 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 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male and female preterm infants with confirmed diagnosis of bilateral ROP who require treatment in China
Who may be able to join
- Signed informed consent from parent(s) or legal guardian(s), in compliance with local requirements
- Male or female preterm infants with a birth weight of less than 1500 g
- Bilateral ROP with 1 of the following retinal findings in each eye:
- Zone I, stage 1+, 2+, 3 or 3+ disease, or
- Zone II, stage 3+ disease, or
- A-ROP
Who cannot join
- Have a history of hypersensitivity (either the patient or the mother) to ranibizumab or any component of the ranibizumab formulation or to drugs of similar chemical classes
- Have been previously exposed to any intravitreal or systemic anti-VEGF agent (either the patient or the mother during this child's pregnancy)
- Have used (either the patient or the mother) other investigational drugs as part of another clinical study (other than vitamins and minerals) within 30 days or within 5 half-lives of the other investigational drug, whichever is longer
- Have received any previous surgical or nonsurgical treatment for ROP (e.g., ablative laser therapy or cryotherapy, vitrectomy)
- Participants who have contraindications according to locally approved ranibizumab label
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 24-week, Open-label, Prospective, Single-arm Study Evaluating the Effectiveness and Safety of Lucentis® (Ranibizumab) 0.2mg in Retinopathy of Prematurity (ROP) Participants in China
This is a 24-week, multicenter, open-label, single-arm, observational, post approval commitment study, which is designed to collect effectiveness, safety and other clinical information of intravitreal ranibizumab 0.2 mg for the treatment of Retinopathy of Prematurity (ROP) participants in a real world clinical setting in mainland China.
Read the detailed description
Eligible participants treated according to local routine clinical practice will be enrolled in the study upon signing an Informed Consent.
Participants will enter the study when they receive their first treatment and are followed up for 24 weeks. During the follow up period, participants could receive post-baseline treatment (i.e., ranibizumab or laser therapy) Patients will be treated according to the approved label and standard of care and as per Investigator judgement.
End of study will be defined as completion of the week 24 visit or premature withdrawal visit
- Conditions
- Retinopathy of Prematurity
- Being tested
- Ranibizumab
- Keywords
- Retinopathy of Prematurity, ROP, NIS, China, ranibizumab
- 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.
RanibizumabOther
Prospective observational study. There is no treatment allocation. Patients prescribed with ranibizumab 0.2 mg in the commercial setting are eligible to enroll into this study.
| Study group | Role | What they receive |
|---|---|---|
| ranibizumab 0.2 mg | Intravitreal ranibizumab 0.2 mg for the treatment of ROP Receives: Other: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with absence of active Retinopathy of Prematurity (ROP) and absence of unfavorable structural outcomes in both eyes during the observational period after starting study treatment.
To achieve this outcome, participants cannot fulfill any of the following criteria:
- Require intervention for ROP in either eye at or before the 24week assessment visit with a treatment modality other than ranibizumab
- Have active ROP in either eye at the 24week assessment visit
- Have unfavorable structural outcomes in either eye at or before 24-week assessment visit
Measured: Week 24
Secondary outcomes (9)
Incidence of AEs
Incidence of AEs will be collected
Measured: Up to 24 weeks
Assessment of length
For the assessment of length the participant should be wearing minimal clothing (e.g., a clean diaper). Recumbent length in centimeters will be measured using an infantometer or according to local clinical practice.
Measured: Baseline, Week 12, and Week 24
Assessment of weight
For the assessment of weight the participant should be wearing minimal clothing (e.g., a clean diaper). Body weight to the nearest gram will be measured using an electronic scale.
Measured: Baseline, Week 12, and Week 24
Assessment of head circumference
For the assessment of head circumference the participant should be wearing minimal clothing (e.g., a clean diaper). The maximum occipitofrontal head circumference in centimeters will be measured using a tape measure.
Measured: Baseline, Week 12, and Week 24
Assessment of lower leg length
For the assessment of lower leg length the participant should be wearing minimal clothing (e.g., a clean diaper).The lower leg length (knee-heel length) will be measured to the nearest 0.1 centimeter using a sliding caliper or according to local clinical practice. Measurements should always be done on the right side, unless a physical deformity affects the right side.
Measured: Baseline, Week 12, and Week 24
Time to intervention with a second modality for ROP or development of unfavorable structural outcome
Time to intervention with a second modality for ROP or development of unfavorable structural outcome will be collected
Measured: Up to 24 weeks
Proportion of participants with re-treatment of ROP receiving any post-baseline intervention
Proportion of participants with re-treatment of ROP receiving any post-baseline intervention at or before 24 weeks
Measured: 24 weeks
number of ranibizumab administrations needed in the treatment of participants with ROP
number of ranibizumab administrations needed in the treatment of participants with ROP will be collected
Measured: 24 weeks
Full retinal vascularization in 12 clock hours
Full retinal vascularization in 12 clock hours at the 24-week assessment to evaluate fundus features of ranibizumab 0.2 mg in the treatment of ROP
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start13 Jan 2023
- Primary completion10 Jul 2024
- Study completion10 Jul 2024
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
- 62 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
- NCT05576792
- Sponsor's protocol ID
- CRFB002H2403
- Status last verified
- Mar 2025
- First submitted
- 10 Oct 2022
- Last updated
- 25 Mar 2025
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week, Open-label, Prospective, Single-arm Study Evaluating the Effectiveness and Safety of Lucentis® (Ranibizumab) 0.2mg in Retinopathy of Prematurity (ROP) Participants in China
- ClinicalTrials.gov ID
- NCT05576792
- Acronym / sponsor ID
- CRFB002H2403
- Conditions
- Retinopathy of Prematurity
- Keywords
- Retinopathy of Prematurity, ROP, NIS, China, ranibizumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 13 Oct 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 is a 24-week, multicenter, open-label, single-arm, observational, post approval commitment study, which is designed to collect effectiveness, safety and other clinical information of intravitreal ranibizumab 0.2 mg for the treatment of Retinopathy of Prematurity (ROP) participants in a real world clinical setting in mainland China.
Detailed description
Eligible participants treated according to local routine clinical practice will be enrolled in the study upon signing an Informed Consent.
Participants will enter the study when they receive their first treatment and are followed up for 24 weeks. During the follow up period, participants could receive post-baseline treatment (i.e., ranibizumab or laser therapy) Patients will be treated according to the approved label and standard of care and as per Investigator judgement.
End of study will be defined as completion of the week 24 visit or premature withdrawal visit
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ranibizumab 0.2 mg | – | Other: RanibizumabIntravitreal ranibizumab 0.2 mg for the treatment of ROP |
Who may qualify
- Ages
- 0 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male and female preterm infants with confirmed diagnosis of bilateral ROP who require treatment in China
Key inclusion criteria (6 listed)
- Signed informed consent from parent(s) or legal guardian(s), in compliance with local requirements
- Male or female preterm infants with a birth weight of less than 1500 g
- Bilateral ROP with 1 of the following retinal findings in each eye:
Key exclusion criteria (5 listed)
- Have a history of hypersensitivity (either the patient or the mother) to ranibizumab or any component of the ranibizumab formulation or to drugs of similar chemical classes
- Have been previously exposed to any intravitreal or systemic anti-VEGF agent (either the patient or the mother during this child's pregnancy)
- Have used (either the patient or the mother) other investigational drugs as part of another clinical study (other than vitamins and minerals) within 30 days or within 5 half-lives of the other investigational drug, whichever is longer
- Have received any previous surgical or nonsurgical treatment for ROP (e.g., ablative laser therapy or cryotherapy, vitrectomy)
- Participants who have contraindications according to locally approved ranibizumab label
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 |
|---|---|---|
| RanibizumabProspective observational study. There is no treatment allocation. Patients prescribed with ranibizumab 0.2 mg in the commercial setting are eligible to enroll into this study. | Other | ranibizumab 0.2 mg |
Primary outcome
Number of participants with absence of active Retinopathy of Prematurity (ROP) and absence of unfavorable structural outcomes in both eyes during the observational period after starting study treatment.
Time frame: Week 24
To achieve this outcome, participants cannot fulfill any of the following criteria: * Require intervention for ROP in either eye at or before the 24week assessment visit with a treatment modality other than ranibizumab * Have active ROP in either eye at the 24week assessment visit * Have unfavorable structural outcomes in either eye at or before 24-week assessment visit
9 secondary outcomes
Incidence of AEs
Time frame: Up to 24 weeks
Assessment of length
Time frame: Baseline, Week 12, and Week 24
Assessment of weight
Time frame: Baseline, Week 12, and Week 24
Assessment of head circumference
Time frame: Baseline, Week 12, and Week 24
Assessment of lower leg length
Time frame: Baseline, Week 12, and Week 24
Time to intervention with a second modality for ROP or development of unfavorable structural outcome
Time frame: Up to 24 weeks
Proportion of participants with re-treatment of ROP receiving any post-baseline intervention
Time frame: 24 weeks
number of ranibizumab administrations needed in the treatment of participants with ROP
Time frame: 24 weeks
Full retinal vascularization in 12 clock hours
Time frame: Week 24
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 25 Mar 2025.
- Results for CRFB002H2403 from the Novartis Clinical Trials 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
1 site 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 1 site in China.
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 6 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 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Number of participants with absence of active Retinopathy of Prematurity (ROP) and absence of unfavorable structural outcomes in both eyes during the observational period after starting study treatment. (time frame: Week 24). 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 25 Mar 2025.