Refractive Error and Biometry in Retinopathy of Prematurity

NCT03334513 | Completed DMC FDA Drug

• 1 other identifier: 171026
• Study Type: observational
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Retinopathy of Prematurity

Keywords

Bevacizumab; Biometry; Ranibizumab; Refractive error; Retinopathy of prematurity

Outcome Measures

Primary Outcomes (2)

• spherical equivalent

  spherical power + half of cylinder power

  at corrected age of 3 year-old

• astigmatism

  in cylinder power

  at corrected age of 3 year-old

Secondary Outcomes (4)

• axial length

  at corrected age of 3 year-old

• cornea radius

  at corrected age of 3 year-old

• anterior chamber depth

  at corrected age of 3 year-old

• lens thickness

  at corrected age of 3 year-old

Study Arms (1)

ROP group

children with retinopathy of prematurity received either bevacizumab or ranibizumab

Drug: Bevacizumab; Drug: Ranibizumab

Interventions

Bevacizumab DRUG

intravitreal injection of bevacizumab

Also known as: avastin

ROP group

Ranibizumab DRUG

intravitreal injection of ranibizumab

Also known as: lucentis

ROP group

Eligibility Criteria

• Age: 3 Years - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

infants who received intravitreal injection of ranibizumab or bevacizumab as the primary treatment

You may qualify if:

• children with type 1 retinopathy of prematurity
• children received anti-vascular endothelial growth factors (bevacizumab or ranibizumab)

You may not qualify if:

• children withour retinopathy of prematurity
• children with retinopathy of prematurity received laser therapy

Sponsors & Collaborators

• San Ni Chen: lead

Related Publications (2)

• 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.

  PMID: 25462435 RESULT

• 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.

  PMID: 29713524 DERIVED

MeSH Terms

Conditions

Retinopathy of Prematurity; Refractive Errors

Interventions

Bevacizumab; Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 7, 2017
• Study Start: April 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: November 7, 2017

Record last verified: 2017-11