Retinopathy of PrematurityNCT03334513
Refractive Error and Biometry in Retinopathy of Prematurity
An observational study of Retinopathy of Prematurity, run by San Ni Chen.
Trial summary
The investigators compared long-term refractive and biometric outcomes in children with retinopathy of prematurity who received two different anti-vascular endothelial growth factor agents. Read more about this study
- Who is it for?
- Ages 3 to 3 years
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- Bevacizumab and Ranibizumab
- Type of treatment
- Injection or infusion
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2011to 1 Apr 2014
- 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 3 to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: infants who received intravitreal injection of ranibizumab or bevacizumab as the primary treatment
Who may be able to join
- children with type 1 retinopathy of prematurity
- children received anti-vascular endothelial growth factors (bevacizumab or ranibizumab)
Who cannot join
- children withour retinopathy of prematurity
- children with retinopathy of prematurity received laser therapy
About this study
Official title: Refractive and Biometric Outcomes in Patients With Retinopathy of Prematurity Treated With Intravitreal Injection of Ranibizumab as Compared With Bevacizumab - a Clinical Study of Correction at Three Years of Age
The investigators compared long-term refractive and biometric outcomes in children with retinopathy of prematurity who received two different anti-vascular endothelial growth factor agents.
Read the detailed description
Purpose:
To compare refractive and biometric outcomes in patients with type 1 retinopathy of prematurity (ROP) treated with intravitreal injection of Ranibizumab (IVR), versus bevacizumab (IVB), at a corrected age of 3 years.
Methods:
A retrospective case series compared cycloplegic refractive statuses and biometric statuses in patients who received either IVR or IVB for Type 1 ROP, from April 2011 to April 2014.
Comparison of refractive errors and biometric findings between the two groups was performmed and multivariate analysis of possible factors contributive to visual acuity was also performmed
- Conditions
- Retinopathy of Prematurity
- Being tested
- Bevacizumab, Ranibizumab
- Keywords
- Bevacizumab, Biometry, Ranibizumab, Refractive error, Retinopathy of prematurity
- Medical subject headings
- Retinopathy of Prematurity, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called avastin
intravitreal injection of bevacizumab
RanibizumabDrug
Also called lucentis
intravitreal injection of ranibizumab
| Study group | Role | What they receive |
|---|---|---|
| ROP group | children with retinopathy of prematurity received either bevacizumab or ranibizumab Receives: Drug: Bevacizumab; Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
spherical equivalent
spherical power + half of cylinder power
Measured: at corrected age of 3 year-old
astigmatism
in cylinder power
Measured: at corrected age of 3 year-old
Secondary outcomes (4)
axial length
axial length in mm
Measured: at corrected age of 3 year-old
cornea radius
cornea radius in mm
Measured: at corrected age of 3 year-old
anterior chamber depth
anterior chamber depth in mm
Measured: at corrected age of 3 year-old
lens thickness
lens thickness in mm
Measured: at corrected age of 3 year-old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start1 Apr 2011
- Primary completion1 Apr 2014
- Study completion1 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Ni Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, San Ni Chen, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334513
- Sponsor's protocol ID
- 171026
- Status last verified
- Nov 2017
- First submitted
- 1 Nov 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Chen SN, Lian I, Hwang YC, Chen YH, Chang YC, Lee KH, Chuang CC, Wu WC. Intravitreal anti-vascular endothelial growth factor treatment for retinopathy of prematurity: comparison between Ranibizumab and Bevacizumab. Retina. 2015 Apr;35(4):667-74. doi: 10.1097/IAE.0000000000000380.
PubMed 25462435Chen YC, Chen SN, Yang BC, Lee KH, Chuang CC, Cheng CY. Refractive and Biometric Outcomes in Patients with Retinopathy of Prematurity Treated with Intravitreal Injection of Ranibizumab as Compared with Bevacizumab: A Clinical Study of Correction at Three Years of Age. J Ophthalmol. 2018 Mar 11;2018:4565216. doi: 10.1155/2018/4565216. eCollection 2018.
PubMed 29713524
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refractive and Biometric Outcomes in Patients With Retinopathy of Prematurity Treated With Intravitreal Injection of Ranibizumab as Compared With Bevacizumab - a Clinical Study of Correction at Three Years of Age
- ClinicalTrials.gov ID
- NCT03334513
- Acronym / sponsor ID
- 171026
- Conditions
- Retinopathy of Prematurity
- Keywords
- Bevacizumab, Biometry, Ranibizumab, Refractive error, Retinopathy of prematurity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- San Ni ChenUniversity, hospital or other
- Study start
- 1 Apr 2011 (actual)
- Primary completion
- 1 Apr 2014 (actual)
- Study completion
- 1 Apr 2014 (actual)
- First posted
- 7 Nov 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.
The investigators compared long-term refractive and biometric outcomes in children with retinopathy of prematurity who received two different anti-vascular endothelial growth factor agents.
Detailed description
Purpose:
To compare refractive and biometric outcomes in patients with type 1 retinopathy of prematurity (ROP) treated with intravitreal injection of Ranibizumab (IVR), versus bevacizumab (IVB), at a corrected age of 3 years.
Methods:
A retrospective case series compared cycloplegic refractive statuses and biometric statuses in patients who received either IVR or IVB for Type 1 ROP, from April 2011 to April 2014.
Comparison of refractive errors and biometric findings between the two groups was performmed and multivariate analysis of possible factors contributive to visual acuity was also performmed
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ROP group | – | Drug: Bevacizumab, Drug: Ranibizumabchildren with retinopathy of prematurity received either bevacizumab or ranibizumab |
Who may qualify
- Ages
- 3 to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- infants who received intravitreal injection of ranibizumab or bevacizumab as the primary treatment
Key inclusion criteria (2 listed)
- children with type 1 retinopathy of prematurity
- children received anti-vascular endothelial growth factors (bevacizumab or ranibizumab)
Key exclusion criteria (2 listed)
- children withour retinopathy of prematurity
- children with retinopathy of prematurity received 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 |
|---|---|---|
| BevacizumabAlso: avastinintravitreal injection of bevacizumab | Drug | ROP group |
| RanibizumabAlso: lucentisintravitreal injection of ranibizumab | Drug | ROP group |
Primary outcome
spherical equivalent
Time frame: at corrected age of 3 year-old
spherical power + half of cylinder power
astigmatism
Time frame: at corrected age of 3 year-old
in cylinder power
4 secondary outcomes
axial length
Time frame: at corrected age of 3 year-old
cornea radius
Time frame: at corrected age of 3 year-old
anterior chamber depth
Time frame: at corrected age of 3 year-old
lens thickness
Time frame: at corrected age of 3 year-old
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 7 Nov 2017.
- Results publication: PubMed 25462435Chen SN, Lian I, Hwang YC, Chen YH, Chang YC, Lee KH, Chuang CC, Wu WC. Intravitreal anti-vascular endothelial growth factor treatment for retinopathy of prematurity: comparison between Ranibizumab and Bevacizumab. Retina. 2015 Apr;35(4):667-74. doi: 10.1097/IAE.0000000000000380.
- Derived from this study: PubMed 29713524Chen YC, Chen SN, Yang BC, Lee KH, Chuang CC, Cheng CY. Refractive and Biometric Outcomes in Patients with Retinopathy of Prematurity Treated with Intravitreal Injection of Ranibizumab as Compared with Bevacizumab: A Clinical Study of Correction at Three Years of Age. J Ophthalmol. 2018 Mar 11;2018:4565216. doi: 10.1155/2018/4565216. eCollection 2018.
Related trials for Retinopathy of Prematurity
RecruitingObservational study
An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)
Retinopathy of Prematurity, Preterm Infants
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
RecruitingObservational study
Imaging Retinal Vasculature in Infant Eyes
Retinopathy of Prematurity
RecruitingPhase 1
Safety, PK and PD of FLQ-101 in Premature Neonates
Retinopathy of Prematurity (ROP)
Recruiting
Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care
Retinopathy of Prematurity (ROP)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinopathy of Prematurity, run by San Ni Chen.
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 2 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 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
spherical equivalent (time frame: at corrected age of 3 year-old). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03334513, which also lists 2 linked publications.
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 7 Nov 2017.