Premature Birth Clinical Trial
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
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
doesn't 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.
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, it's
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 don't 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 (0.500mg/0.02mL) versus Ranibizumab (0.25 mg/0.025mL) 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 0.5mg/0.02mL or Ranibizumab 0.25mg/0.25 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.
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