VEGF Concentrations After Intravitreal Bevacizumab vs Ranibizumab as a Treatment for Type 1 ROP

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Retinal Disease, Retinopathy of Prematurity Both Eyes, Premature Birth, Eye Diseases

Intervention / Treatment
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* Drug: Bevacizumab Injection
* Drug: Ranibizumab Ophthalmic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Premature newborns that fulfill the criteria for type 1 ROP, according to the Early Treatment of ROP classification on both eyes. Exclusion Criteria: Patients that do not continue the required evaluations.

Ages Eligible for Study
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Minimum Age: 28 Days
Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group 1: Patients that fullfil type 1 ROP criteria that will be treated with Bevacizumab Group 2: Patients that fullfil type 1 ROP criteria that will be treated with Ranibizumab
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bevacizumab injection<br>Application of Intravitreal Bevacizumab (0.50mg/0.02mL), unique dosis | Drug: Bevacizumab Injection<br>* 0.5mg/0.02 mL<br>* Other names: Intravitreal;|
| Experimental: Ranibizumab Ophthalmic<br>Application of Intravitreal Ranibizumab (0.25mg/0.025mL), unique dosis | Drug: Ranibizumab Ophthalmic<br>* 0.25mg/0.025 mL<br>* Other names: Intravitreal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the serum VEGF concentrations after intravitreal application of Bevacizumab vs Ranibizumab | Evaluate the Serum VEGF concentration with the ELISA assay after intravitreal application of Bevacizumab or ranibizumab | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retinopathy of Prematurity, VEGF, Bevacizumab, Ranibizumab