Ignite Creation Date:
2024-05-06 @ 10:02 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03148132
Status:
COMPLETED
Last Update Posted:
2019-01-09
First Post:
2017-05-08
Brief Title:
VEGF Concentrations After Intravitreal Bevacizumab vs Ranibizumab as a Treatment for Type 1 ROP
Sponsor:
Universidad Autonoma de San Luis PotosÃ
Organization:
Universidad Autonoma de San Luis PotosÃ
Study Overview
Official Title:
Comparison of the Vascular Endothelial Growth Factor Serum Concentrations After Intravitreal Use of Bevacizumab or Ranibizumab as a Treatment for Type 1 Retinopathy of Prematurity
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Retinopathy of Prematurity ROP is one of the leading causes of blindness on the pediatric age worldwide This pathology is characterized for arrest of the normal vascular and neuronal retina that because of pathological compensatory mechanisms results in proliferation of vascular tissue that grow in the limit between the vascular retina and the avascular retina
The ET-ROP group classified the ROP by those who need treatment immediately or those who doesnt need treatment The classification is the following Type 1 ROP--ROP zone I any stage with plus zone I stage 3 without plus zone II stage 2 y 3 with plus Type 2 ROP -- Zone 1 Stage 2 or 3 without plus and Zone II stage 3 without plus
The treatment is begun on patient with type 1 ROP and type 2 ROP is maintained in observation
The ET-ROP group classified the ROP by those who need treatment immediately or those who doesnt need treatment The classification is the following Type 1 ROP--ROP zone I any stage with plus zone I stage 3 without plus zone II stage 2 y 3 with plus Type 2 ROP -- Zone 1 Stage 2 or 3 without plus and Zone II stage 3 without plus
The treatment is begun on patient with type 1 ROP and type 2 ROP is maintained in observation
Detailed Description:
It has been documented that de Vascular Endothelial Growth Factor VEGF is involved on the physiopathology of this disease
The VEGF is a glucoprotein that regulates the angiogenesis and the vasculogenesis its presence is crucial on the growth and development of several tissues around the organism
Nowadays the treatment of type 1 ROP it si focus on the disminution of the intravitreal VEGF after the intravitreal application of drugs like Bevacizumab and Ranibizumab
However these drugs can pass through the hematorretinal barrier in to the blood stream where they can also decrease the systemic levels of VEGF
We still dont know the long term effects of the intravitreal application of these drugs on premature babies but there is the concern
The objective of this study is to compare the serum VEGF concentrations after intravitreal application of Bevacizumab 0500mg002mL versus Ranibizumab 025 mg0025mL for the treatment of type 1 ROP
HYPOTESIS The serum VEGF concentrations after the intravitreal application of Bevacizumab will be smaller than the serum VEGF concentrations after the intravitreal application of Ranibizumab
METHODOLOGY Safety ECCA Inclusion criteria premature newborns who fulfill the criteria for type 1 ROP according to the ET-ROP classification
The investigators will identify the patients that can be included The principal investigator will take a blood sample of 500 microliters and then the patients would receive intravitreal treatment assigned randomly Bevacizumab 05mg002mL or Ranibizumab 025mg025 mL
The principal investigator will take new blood samples a day 2 weeks and 8 weeks after the application of the intravitreal treatment these samples will be frozen to further analysis
The analysis will be performed by ELISA kits
The investigators are going to describe the results of the ELISA for the blood samples and then make a comparison between both groups
The VEGF is a glucoprotein that regulates the angiogenesis and the vasculogenesis its presence is crucial on the growth and development of several tissues around the organism
Nowadays the treatment of type 1 ROP it si focus on the disminution of the intravitreal VEGF after the intravitreal application of drugs like Bevacizumab and Ranibizumab
However these drugs can pass through the hematorretinal barrier in to the blood stream where they can also decrease the systemic levels of VEGF
We still dont know the long term effects of the intravitreal application of these drugs on premature babies but there is the concern
The objective of this study is to compare the serum VEGF concentrations after intravitreal application of Bevacizumab 0500mg002mL versus Ranibizumab 025 mg0025mL for the treatment of type 1 ROP
HYPOTESIS The serum VEGF concentrations after the intravitreal application of Bevacizumab will be smaller than the serum VEGF concentrations after the intravitreal application of Ranibizumab
METHODOLOGY Safety ECCA Inclusion criteria premature newborns who fulfill the criteria for type 1 ROP according to the ET-ROP classification
The investigators will identify the patients that can be included The principal investigator will take a blood sample of 500 microliters and then the patients would receive intravitreal treatment assigned randomly Bevacizumab 05mg002mL or Ranibizumab 025mg025 mL
The principal investigator will take new blood samples a day 2 weeks and 8 weeks after the application of the intravitreal treatment these samples will be frozen to further analysis
The analysis will be performed by ELISA kits
The investigators are going to describe the results of the ELISA for the blood samples and then make a comparison between both groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None