Infant, Premature, Diseases
Conditions
Keywords
retinopathy of prematurity, ranibizumab, vascular endothelial growth factor
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.
Interventions
0.25 mg intravitreal ranibizumab to either 1 eye (unilateral cases) or both eyes (bilateral cases)
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Weeks to 3 Months
Healthy volunteers
No
Inclusion criteria
* Infants with vascularly active ROP * intravitreal ranibizumab
Exclusion criteria
* already accepted laser therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed