Serum Vascular Endothelial Growth Factor in Infants With Intravitreal Ranibizumab

Overview

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

Full Title of Study: “Serum Concentrations of Vascular Endothelial Growth Factor in Infants Treated With Ranibizumab for Retinopathy of Prematurity”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 31, 2018

Detailed Description

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: serum VEGF level
    • Serum samples are collected 1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • The effect of intravitreal ranibizumab on weight
    • Time Frame: corrected age of six month
    • measure weight of the infants
  • The effect of intravitreal ranibizumab on height
    • Time Frame: corrected age of six month
    • measure height of the infants
  • The effect of intravitreal ranibizumab on neurologic development
    • Time Frame: corrected age of six month
    • Gesell development diagnosis scale

Participating in This Clinical Trial

Inclusion Criteria

  • Infants with vascularly active ROP – intravitreal ranibizumab Exclusion Criteria:

  • already accepted laser therapy

Gender Eligibility: All

Minimum Age: 4 Weeks

Maximum Age: 3 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hongping Xia, MD. PhD, Principal Investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.