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
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