VEGF Concentrations After Intravitreal Bevacizumab vs Ranibizumab as a Treatment for Type 1 ROP
Condition: Retinopathy of Prematurity Both Eyes; Retinal Disease; Premature Birth; Eye Diseases
MeSH terms: Retinal Diseases; Eye Diseases; Retinopathy of Prematurity; Premature Birth
Study type: Interventional
Phase: Phase 4

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
      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: 
      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.
    

Intervention name(s): Bevacizumab Injection; Ranibizumab Ophthalmic
Intervention type(s): Drug; Drug
Intervention description(s): 0.5mg/0.02 mL; 0.25mg/0.025 mL
Other intervention name(s): Intravitreal; Intravitreal
Intervention MeSH terms: Bevacizumab; Ranibizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Retinopathy of Prematurity; VEGF; Bevacizumab; Ranibizumab