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NCT03115255 Clinical Trial

Serum Vascular Endothelial Growth Factor in Infants With Intravitreal Ranibizumab

Infant, Premature, Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03115255
Other study ID # XH-17-004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date June 30, 2018

Study information
Verified date April 2018
Source Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 17
Est. completion date June 30, 2018
Est. primary completion date May 31, 2018
Accepts healthy volunteers No
Gender All
Age group N/A to 3 Months
Eligibility Inclusion Criteria:

- Infants with vascularly active ROP

- intravitreal ranibizumab

Exclusion Criteria:

- already accepted laser therapy

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
China Xinhua Hospital Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The effect of intravitreal ranibizumab on serum VEGF level the changes of the serum VEGF levels 1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab
Secondary The effect of intravitreal ranibizumab on weight measure weight of the infants corrected age of six month
Secondary The effect of intravitreal ranibizumab on height measure height of the infants corrected age of six month
Secondary The effect of intravitreal ranibizumab on neurologic development Gesell development diagnosis scale corrected age of six month
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