Infant, Premature, DiseasesNCT03115255
Serum Vascular Endothelial Growth Factor in Infants With Intravitreal Ranibizumab
A study testing intravitreal ranibizumab in people with Infant, Premature, Diseases, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
To determine the serum concentrations of ranibizumab and vascular endothelial growth factor (VEGF) in infants with retinopathy of prematurity (ROP) who received intravitreal ranibizumab Read more about this study
- Who is it for?
- Ages 4 weeks to 3 months
- Conditions the study is for
- Infant, Premature, Diseases
- What is being tested?
- intravitreal ranibizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 30 Jun 2018
- Phase
- Interventional
- 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 4 weeks to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants with vascularly active ROP
- intravitreal ranibizumab
Who cannot join
- already accepted laser therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Concentrations of Vascular Endothelial Growth Factor in Infants Treated With Ranibizumab for Retinopathy of Prematurity
To determine the serum concentrations of ranibizumab and vascular endothelial growth factor (VEGF) in infants with retinopathy of prematurity (ROP) who received intravitreal ranibizumab
Read the detailed description
Infants with ROP are studied. They received 0.25 mg or 0.5 mg of intravitreal ranibizumab to either 1 eye (unilateral cases) or both eyes (bilateral cases) with vascularly active ROP. Serum samples are collected 1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab. The serum concentrations of ranibizumab and VEGF are measured by enzyme-linked immunosorbent assay, and the changes of the serum VEGF levels are determined.
- Conditions
- Infant, Premature, Diseases
- Being tested
- intravitreal ranibizumab
- Keywords
- retinopathy of prematurity, ranibizumab, vascular endothelial growth factor
- Medical subject headings
- Infant, Premature, Diseases, Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravitreal ranibizumabDrug
Also called lucentis
0.25 mg intravitreal ranibizumab to either 1 eye (unilateral cases) or both eyes (bilateral cases)
| Study group | Role | What they receive |
|---|---|---|
| serum VEGF level | Experimental | Serum samples are collected 1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab Receives: Drug: intravitreal ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of intravitreal ranibizumab on serum VEGF level
the changes of the serum VEGF levels
Measured: 1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab
Secondary outcomes (3)
The effect of intravitreal ranibizumab on weight
measure weight of the infants
Measured: corrected age of six month
The effect of intravitreal ranibizumab on height
measure height of the infants
Measured: corrected age of six month
The effect of intravitreal ranibizumab on neurologic development
Gesell development diagnosis scale
Measured: corrected age of six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start1 May 2017
- Primary completion31 May 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Premature, DiseasesStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongping Xia, MD. PhD, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115255
- Sponsor's protocol ID
- XH-17-004
- Status last verified
- Apr 2018
- First submitted
- 27 Mar 2017
- Last updated
- 12 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Concentrations of Vascular Endothelial Growth Factor in Infants Treated With Ranibizumab for Retinopathy of Prematurity
- ClinicalTrials.gov ID
- NCT03115255
- Acronym / sponsor ID
- XH-17-004
- Conditions
- Infant, Premature, Diseases
- Keywords
- retinopathy of prematurity, ranibizumab, vascular endothelial growth factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 14 Apr 2017 (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.
To determine the serum concentrations of ranibizumab and vascular endothelial growth factor (VEGF) in infants with retinopathy of prematurity (ROP) who received intravitreal ranibizumab
Detailed description
Infants with ROP are studied. They received 0.25 mg or 0.5 mg of intravitreal ranibizumab to either 1 eye (unilateral cases) or both eyes (bilateral cases) with vascularly active ROP. Serum samples are collected 1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab. The serum concentrations of ranibizumab and VEGF are measured by enzyme-linked immunosorbent assay, and the changes of the serum VEGF levels are determined.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| serum VEGF level | Experimental | Drug: intravitreal ranibizumabSerum samples are collected 1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab |
Who may qualify
- Ages
- 4 weeks to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants with vascularly active ROP
- intravitreal ranibizumab
Key exclusion criteria (1 listed)
- already accepted laser therapy
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 |
|---|---|---|
| intravitreal ranibizumabAlso: lucentis0.25 mg intravitreal ranibizumab to either 1 eye (unilateral cases) or both eyes (bilateral cases) | Drug | serum VEGF level |
Primary outcome
The effect of intravitreal ranibizumab on serum VEGF level
Time frame: 1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab
the changes of the serum VEGF levels
3 secondary outcomes
The effect of intravitreal ranibizumab on weight
Time frame: corrected age of six month
The effect of intravitreal ranibizumab on height
Time frame: corrected age of six month
The effect of intravitreal ranibizumab on neurologic development
Time frame: corrected age of six month
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 12 Oct 2018.
- 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.
Hongping Xia, MD. PhD principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intravitreal ranibizumab in people with Infant, Premature, Diseases, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 2 inclusion and 1 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 12 Oct 2018. 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?
The effect of intravitreal ranibizumab on serum VEGF level (time frame: 1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab). 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 12 Oct 2018; AzTrials last refreshed its copy on 7 Nov 2026.