- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03334513
Refractive Error and Biometry in Retinopathy of Prematurity
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- children with type 1 retinopathy of prematurity
- children received anti-vascular endothelial growth factors (bevacizumab or ranibizumab)
Exclusion Criteria:
- children withour retinopathy of prematurity
- children with retinopathy of prematurity received laser therapy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ROP group
children with retinopathy of prematurity received either bevacizumab or ranibizumab
|
intravitreal injection of bevacizumab
Other Names:
intravitreal injection of ranibizumab
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
spherical equivalent
Time Frame: at corrected age of 3 year-old
|
spherical power + half of cylinder power
|
at corrected age of 3 year-old
|
astigmatism
Time Frame: at corrected age of 3 year-old
|
in cylinder power
|
at corrected age of 3 year-old
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
axial length
Time Frame: at corrected age of 3 year-old
|
axial length in mm
|
at corrected age of 3 year-old
|
cornea radius
Time Frame: at corrected age of 3 year-old
|
cornea radius in mm
|
at corrected age of 3 year-old
|
anterior chamber depth
Time Frame: at corrected age of 3 year-old
|
anterior chamber depth in mm
|
at corrected age of 3 year-old
|
lens thickness
Time Frame: at corrected age of 3 year-old
|
lens thickness in mm
|
at corrected age of 3 year-old
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Chen 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Infant, Newborn, Diseases
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Infant, Premature, Diseases
- Retinal Diseases
- Refractive Errors
- Premature Birth
- Retinopathy of Prematurity
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Ranibizumab
- Bevacizumab
Other Study ID Numbers
- 171026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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