Serum Vascular Endothelial Growth Factor in Infants With Intravitreal Ranibizumab

Not Applicable

Completed

• Conditions: Infant, Premature, Diseases
• Interventions: Drug: intravitreal ranibizumab

• Registration Number: NCT03115255
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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 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.

Study Timeline

• Study First Submitted: 2017-03-27
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-14
• Study Start: 2017-05-01
• Status Verified: 2018-04
• Primary Completion: 2018-05-31
• Study Completion: 2018-06-30
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Infants with vascularly active ROP
• intravitreal ranibizumab

Exclusion Criteria

• already accepted laser therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
serum VEGF level	intravitreal ranibizumab	Serum samples are collected 1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab

Primary Outcome Measures

Name	Time	Method
The effect of intravitreal ranibizumab on serum VEGF level	1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab	the changes of the serum VEGF levels

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Xinhua Hospital; 🇨🇳 Shanghai, Shanghai, China