VEGF Concentrations After Intravitreal Bevacizumab vs Ranibizumab as a Treatment for Type 1 ROP
NCT ID: NCT03148132
Last Updated: 2019-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
16 participants
INTERVENTIONAL
2017-05-23
2018-08-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Bevacizumab injection
Application of Intravitreal Bevacizumab (0.50mg/0.02mL), unique dosis
Bevacizumab Injection
0.5mg/0.02 mL
Ranibizumab Ophthalmic
Application of Intravitreal Ranibizumab (0.25mg/0.025mL), unique dosis
Ranibizumab Ophthalmic
0.25mg/0.025 mL
Interventions
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Bevacizumab Injection
0.5mg/0.02 mL
Ranibizumab Ophthalmic
0.25mg/0.025 mL
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
28 Days
3 Months
ALL
No
Sponsors
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Hospital Central "Dr. Ignacio Morones Prieto"
OTHER
Universidad Autonoma de San Luis Potosí
OTHER
Responsible Party
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Ada Gabriela Hernández Gámez
MD
Principal Investigators
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Martha G Rangel, MD
Role: STUDY_DIRECTOR
Hospital Central "Dr. Ignacio Morones Prieto"
Locations
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Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosí City, , Mexico
Countries
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Other Identifiers
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31-17
Identifier Type: -
Identifier Source: org_study_id
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