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Trial record 5 of 294 for:    retinopathy of prematurity

Refractive Error and Biometry in Retinopathy of Prematurity

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ClinicalTrials.gov Identifier: NCT03334513
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
San Ni Chen, Changhua Christian Hospital

Brief 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.

Condition or disease Intervention/treatment
Retinopathy of Prematurity Drug: Bevacizumab Drug: Ranibizumab

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


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Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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
Actual Study Start Date : April 1, 2011
Actual Primary Completion Date : April 1, 2014
Actual Study Completion Date : April 1, 2014


Group/Cohort Intervention/treatment
ROP group
children with retinopathy of prematurity received either bevacizumab or ranibizumab
Drug: Bevacizumab
intravitreal injection of bevacizumab
Other Name: avastin

Drug: Ranibizumab
intravitreal injection of ranibizumab
Other Name: lucentis




Primary Outcome Measures :
  1. spherical equivalent [ Time Frame: at corrected age of 3 year-old ]
    spherical power + half of cylinder power

  2. astigmatism [ Time Frame: at corrected age of 3 year-old ]
    in cylinder power


Secondary Outcome Measures :
  1. axial length [ Time Frame: at corrected age of 3 year-old ]
    axial length in mm

  2. cornea radius [ Time Frame: at corrected age of 3 year-old ]
    cornea radius in mm

  3. anterior chamber depth [ Time Frame: at corrected age of 3 year-old ]
    anterior chamber depth in mm

  4. lens thickness [ Time Frame: at corrected age of 3 year-old ]
    lens thickness in mm



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Ages Eligible for Study:   3 Years to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
infants who received intravitreal injection of ranibizumab or bevacizumab as the primary treatment
Criteria

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

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: San Ni Chen, medical doctor, Changhua Christian Hospital
ClinicalTrials.gov Identifier: NCT03334513     History of Changes
Other Study ID Numbers: 171026
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by San Ni Chen, Changhua Christian Hospital:
Bevacizumab
Biometry
Ranibizumab
Refractive error
Retinopathy of prematurity

Additional relevant MeSH terms:
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Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Obstetric Labor, Premature
Infant, Premature, Diseases
Refractive Errors
Eye Diseases
Obstetric Labor Complications
Pregnancy Complications
Infant, Newborn, Diseases
Bevacizumab
Ranibizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors