Bevacizumab 0.500MG Intravitreal There Isn't Lower Than 0.625MG in the Treatment of ROP Type 1
NCT ID: NCT02090322
Last Updated: 2014-03-18
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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UNKNOWN
NA
60 participants
INTERVENTIONAL
2013-09-30
2014-03-31
Brief Summary
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The ROP is classified for: location (zones I,II,III), extension (hours 1 to 12) and for stages (1,2,3,4a,4b,5) and features of the vessels (normal, pre-plus and plus).
With the diagnosis of ROP type 1(ROP zone I any stage with plus, zone I stage 3 without plus, zone II stage 2 y 3 with plus) the treatment is begun and ROP type 2 is maintained in observation.
The altered regulation of Vascular Endothelial Grow Factor (VEGF) has been proposed as one of the principal factors in the pathogenesis of ROP.
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Detailed Description
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It's known that intravitreal bevacizumab arrives blood and there aren't reports of secondary efects in this moment, however, we want demonstrate that for the weight and volume of the premature baby's eye, we need a low dosis and then we will have less sistemic effect.
HYPOTHESIS:The injection of 0.500 mg of Bevacizumab intravitreal it isnt lower that 0.625 mg of Bevacizumab intravitreal for the regression of ROP type 1 OBJECTIVE: Demonstrate that 0.500mg of Bevacizumab intravitreal isn't inferior that 0.625mg in the resolution of ROP type 1.
METHODOLOGY: No inferiority study. ECCA. We are going to include premature patients prematures with less of 32SDG and/or 1500g and less of 36SDG with factors risk. They are going to be examined in the week fourth, with de diagnosis for ROP type 1, we are going to inject intravitreal Bevacizumab, with the dosis randomized (0.500mg and 0.625mg) and they are going to be examined another time at first week, two weeks, first month, and for the second to sixth month after the treatment, for warrant la resolution of ROP. The size simple is 30 patients for group (Dosis A and Dosis B).
We are going to describe the date of the infection, and the age of the baby when the bevacizumab was inyected. When the ROP have been in regression, we are going to describe the date, and finally we are going to describe the age is going to be the baby she the ROP have been in regression.
It is going to be important determine the concept of exit and failure. And finally demonstrate if the two dosage have a good result
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Bevacizumab
The treatment for Retinopathy of prematurity is Intravitreal bevacizumab. We want to compare two dosages (0.500 and 0.625mg) and demonstrate that 0.500mg there isn't lower in efficacy than 0.625mg.
When the baby have the diagnosis or Retinopathy of prematurity we are going to inyect the eye that have te problem, then we are going to explore until this illness disappear. It is only one intervention
Injection of bevacizumab intravitreal (Avastin)
The treatment of Retinopathy of prematurity is with bevacizumab intravitreal for resolution of the illness.
When there is a Retinopathy of prematurity type 1, is the indication for the infection
Interventions
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Injection of bevacizumab intravitreal (Avastin)
The treatment of Retinopathy of prematurity is with bevacizumab intravitreal for resolution of the illness.
When there is a Retinopathy of prematurity type 1, is the indication for the infection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Month
4 Months
ALL
No
Sponsors
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Universidad Autonoma de San Luis Potosí
OTHER
Responsible Party
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Martha Giselda Rangel Charqueño
Dra.Martha Giselda Rangel Charqueño
Principal Investigators
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Rangel Ch Martha, Speciality
Role: PRINCIPAL_INVESTIGATOR
Universidad Autónoma de San Luis Potosí
Locations
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Hospital Central Dr. "IMP"
Mexico, San Luis Potosí, Mexico
Hospital Central Dr."IMP"
Mexico, San Luis Potosí, Mexico
Hospital Central Dr."IMP"
Mexico, San Luis Potosí, Mexico
Countries
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Facility Contacts
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Other Identifiers
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72-12
Identifier Type: -
Identifier Source: org_study_id
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