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

March 17, 2014 updated by: Martha Giselda Rangel Charqueño, Universidad Autonoma de San Luis Potosí

Study of no Inferiority Between Two Doses (0.500mg and 0.625mg) of Bevacizumab Intravitreal in the Treatment of Retinopathy of Prematurity Type 1

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • San Luis Potosí
      • Mexico, San Luis Potosí, Mexico, 78240
        • Recruiting
        • Hospital Central Dr. "IMP"
        • Contact:
        • Contact:
        • Principal Investigator:
          • MARTHA RANGEL, DR
      • Mexico, San Luis Potosí, Mexico
        • Recruiting
        • Hospital Central Dr."IMP"
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rangel Martha, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 4 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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:
  • Avastin
  • Antiangiogenic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regression of Retinopathy of prematurity
Time Frame: 4 months
Injection of bevacizumab and regression of this
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de San Luis Potosí

Investigators

  • Principal Investigator: Rangel Ch Martha, Speciality, Universidad Autonoma de San Luis Potosí

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ANTICIPATED)

March 1, 2014

Study Registration Dates

First Submitted

February 20, 2014

First Submitted That Met QC Criteria

March 17, 2014

First Posted (ESTIMATE)

March 18, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 18, 2014

Last Update Submitted That Met QC Criteria

March 17, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 72-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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