Clinical Trial: Serum Vascular Endothelial Growth Factor in Infants With Intravitreal Ranibizumab
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Serum Concentrations of Vascular Endothelial Growth Factor in Infants Treated With Ranibizumab for Retinopathy of Prematurity
Brief Summary: To determine the serum concentrations of ranibizumab and vascular endothelial growth factor (VEGF) in infants with retinopathy of prematurity (ROP) who received intravitreal ranibizumab
Detailed Summary: 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.
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Current Primary Outcome: The effect of intravitreal ranibizumab on serum VEGF level [ Time Frame: 1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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
Original Secondary Outcome: Same as current
Information By: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Dates:
Date Received: March 27, 2017
Date Started: May 1, 2017
Date Completion: December 2018
Last Updated: April 10, 2017
Last Verified: March 2017