Back to resultsSerum Vascular Endothelial Growth Factor in Infants With Intravitreal Ranibizumab
Primary Purpose
Infant, Premature, Diseases
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
intravitreal ranibizumab
Sponsored by
About this trial
This is an interventional health services research trial for Infant, Premature, Diseases focused on measuring retinopathy of prematurity, ranibizumab, vascular endothelial growth factor
Eligibility Criteria
Inclusion Criteria:
- Infants with vascularly active ROP
- intravitreal ranibizumab
Exclusion Criteria:
- already accepted laser therapy
Sites / Locations
- Xinhua Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
serum VEGF level
Arm Description
Serum samples are collected 1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab
Outcomes
Primary Outcome Measures
The effect of intravitreal ranibizumab on serum VEGF level
the changes of the serum VEGF levels
Secondary Outcome Measures
The effect of intravitreal ranibizumab on weight
measure weight of the infants
The effect of intravitreal ranibizumab on height
measure height of the infants
The effect of intravitreal ranibizumab on neurologic development
Gesell development diagnosis scale
Full Information
NCT ID
NCT03115255
First Posted
March 27, 2017
Last Updated
October 10, 2018
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03115255
Brief Title
Serum Vascular Endothelial Growth Factor in Infants With Intravitreal Ranibizumab
Official Title
Serum Concentrations of Vascular Endothelial Growth Factor in Infants Treated With Ranibizumab for Retinopathy of Prematurity
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Premature, Diseases
Keywords
retinopathy of prematurity, ranibizumab, vascular endothelial growth factor
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
serum VEGF level
Arm Type
Experimental
Arm Description
Serum samples are collected 1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab
Intervention Type
Drug
Intervention Name(s)
intravitreal ranibizumab
Other Intervention Name(s)
lucentis
Intervention Description
0.25 mg intravitreal ranibizumab to either 1 eye (unilateral cases) or both eyes (bilateral cases)
Primary Outcome Measure Information:
Title
The effect of intravitreal ranibizumab on serum VEGF level
Description
the changes of the serum VEGF levels
Time Frame
1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab
Secondary Outcome Measure Information:
Title
The effect of intravitreal ranibizumab on weight
Description
measure weight of the infants
Time Frame
corrected age of six month
Title
The effect of intravitreal ranibizumab on height
Description
measure height of the infants
Time Frame
corrected age of six month
Title
The effect of intravitreal ranibizumab on neurologic development
Description
Gesell development diagnosis scale
Time Frame
corrected age of six month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Weeks
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Infants with vascularly active ROP
intravitreal ranibizumab
Exclusion Criteria:
already accepted laser therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongping Xia, MD. PhD
Organizational Affiliation
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xinhua Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Serum Vascular Endothelial Growth Factor in Infants With Intravitreal Ranibizumab
We'll reach out to this number within 24 hrs