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Completed

NCT Number: NCT03115255

Serum Vascular Endothelial Growth Factor in Infants With Intravitreal Ranibizumab

To determine the serum concentrations of ranibizumab and vascular endothelial growth factor (VEGF) in infants with retinopathy of prematurity (ROP) who received intravitreal ranibizumab

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Key information

Conditions

Infant, Premature, Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Infant, Newborn, Diseases Retinal Diseases Retinopathy of Prematurity

Age range

4 week–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants with vascularly active ROP
  • intravitreal ranibizumab

Exclusion criteria

  • already accepted laser therapy

Treatment and study plan

Intravitreal ranibizumab

Drug

0.25 mg intravitreal ranibizumab to either 1 eye (unilateral cases) or both eyes (bilateral cases)

Other names: lucentis

Primary outcomes

  1. 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

Secondary outcomes

  1. The effect of intravitreal ranibizumab on weight

    Time frame: corrected age of six month

    measure weight of the infants

  2. The effect of intravitreal ranibizumab on height

    Time frame: corrected age of six month

    measure height of the infants

  3. The effect of intravitreal ranibizumab on neurologic development

    Time frame: corrected age of six month

    Gesell development diagnosis scale

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Serum Concentrations of Vascular Endothelial Growth Factor in Infants Treated With Ranibizumab for Retinopathy of Prematurity

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 14, 2017
Registry last updated
Oct 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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