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Trial record 15 of 293 for:    retinopathy of prematurity

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

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ClinicalTrials.gov Identifier: NCT02090322
Recruitment Status : Unknown
Verified March 2014 by Martha Giselda Rangel Charqueño, Universidad Autonoma de San Luis Potosí.
Recruitment status was:  Recruiting
First Posted : March 18, 2014
Last Update Posted : March 18, 2014
Sponsor:
Information provided by (Responsible Party):
Martha Giselda Rangel Charqueño, 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.


Condition or disease Intervention/treatment Phase
Retinopathy of Prematurity Procedure: Injection of bevacizumab intravitreal (Avastin) Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study of no Inferiority Between Two Doses (0.500mg and 0.625mg) of Bevacizumab Intravitreal in the Treatment of Retinopathy of Prematurity Type 1
Study Start Date : September 2013
Actual Primary Completion Date : March 2014
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: 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

Procedure: 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 Names:
  • Antiangiogenic
  • Avastin




Primary Outcome Measures :
  1. Regression of Retinopathy of prematurity [ Time Frame: 4 months ]
    Injection of bevacizumab and regression of this



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02090322


Locations
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Mexico
Hospital Central Dr. "IMP" Recruiting
Mexico, San Luis Potosí, Mexico, 78240
Contact: Rangel Martha, Dr    014448262300 ext 6688    gisorangel@gmail.com   
Contact: Sánchez Martín, M.C    014448262300 ext 6688    jemarsan7@hotmail.com   
Principal Investigator: MARTHA RANGEL, DR         
Hospital Central Dr."IMP" Recruiting
Mexico, San Luis Potosí, Mexico
Contact: Rangel Martha, Dr.    014448262300    gisorangel@gmail.com   
Principal Investigator: Rangel Martha, Dr         
Hospital Central Dr."IMP" Recruiting
Mexico, San Luis Potosí, Mexico
Contact: Rangel Martha, Dr    014441981000 ext 612    gisorangel@gmail.com   
Contact: Sánchez Jesús Martín, Dr    014448262300    jemarsan7@hotmail.com   
Principal Investigator: Rangel Martha, Dr.         
Sponsors and Collaborators
Universidad Autonoma de San Luis Potosí
Investigators
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Principal Investigator: Rangel Ch Martha, Speciality Universidad Autónoma de San Luis Potosí

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Responsible Party: Martha Giselda Rangel Charqueño, Dra.Martha Giselda Rangel Charqueño, Universidad Autonoma de San Luis Potosí
ClinicalTrials.gov Identifier: NCT02090322     History of Changes
Other Study ID Numbers: 72-12
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: March 18, 2014
Last Verified: March 2014

Keywords provided by Martha Giselda Rangel Charqueño, Universidad Autonoma de San Luis Potosí:
ROP
Bevacizumab
No inferiority

Additional relevant MeSH terms:
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Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Obstetric Labor, Premature
Infant, Premature, Diseases
Eye Diseases
Obstetric Labor Complications
Pregnancy Complications
Infant, Newborn, Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors