Bevacizumab 0.500MG Intravitreal There Isn't Lower Than 0.625MG in the Treatment of ROP Type 1

Not Applicable

• Conditions: Retinopathy of Prematurity
• Interventions: Procedure: Injection of bevacizumab intravitreal (Avastin)

• Registration Number: NCT02090322
• Lead Sponsor: Universidad Autonoma de San Luis Potosí

Brief Summary

The Retinopathy of Prematurity (ROP) is a Retina's pathology only of the premature baby, it's characterized for proliferation of vascular tissue that grow in the limit between the vascular retina and the avascular retina. The altered regulation of Vascular Endothelial Grow Factor (VEGF) has been proposed as one of the principal factor in the pathogenesis of the ROP.

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.

Detailed Description

ustification: Before the treatment was with Cryotherapy and the standard gold is the laser, however the retina tissue is destroyed, and there is loss of visual field and as this procedure has need to be with general anesthesia, there may be trans and post surgical complications. Currently the intravitreal antiangiogenics are been employed (that inhibit the VEGF), specially the Bevacizumab, it's a quickly procedure with topic anesthesia and low price, with a good results.

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

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-02-20
• Status Verified: 2014-03
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Study First Submitted QC: 2014-03-17
• Last Update Submitted: 2014-03-17
• Study First Posted: 2014-03-18
• Last Update Posted: 2014-03-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Prematurity, low weight, oxygen, retinopathy of prematurity type 1

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Exclusion Criteria

• Retinopathy of prematurity type 2, retinopathy of prematurity stage 4 or 5

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bevacizumab	Injection of bevacizumab intravitreal (Avastin)	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

Primary Outcome Measures

Name	Time	Method
Regression of Retinopathy of prematurity	4 months	Injection of bevacizumab and regression of this

Trial Locations

Locations (2)

Hospital Central Dr. "IMP"; 🇲🇽 Mexico, San Luis Potosí, Mexico

Hospital Central Dr."IMP"; 🇲🇽 Mexico, San Luis Potosí, Mexico