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Completed

NCT Number: NCT03148132

VEGF Concentrations After Intravitreal Bevacizumab vs Ranibizumab as a Treatment for Type 1 ROP

The Retinopathy of Prematurity (ROP) is one of the leading causes of blindness on the pediatric age worldwide. This pathology is characterized for arrest of the normal vascular and neuronal retina that because of pathological compensatory mechanisms results in proliferation of vascular tissue that grow in the limit between the vascular retina and the avascular retina.

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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Key information

Conditions

Retinopathy of Prematurity Both Eyes Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Retinal Disease Retinal Diseases Retinopathy of Prematurity Urogenital Diseases

Age range

28 day–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Central "Dr. Ignacio Morones Prieto"

San Luis Potosí City, 78170, Mexico

About this study

It has been documented that de Vascular Endothelial Growth Factor (VEGF) is involved on the physiopathology of this disease.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Premature newborns that fulfill the criteria for type 1 ROP, according to the Early Treatment of ROP classification on both eyes.

Exclusion criteria

  • Patients that do not continue the required evaluations.

Treatment and study plan

Bevacizumab Injection

Drug

0.5mg/0.02 mL

Other names: Intravitreal

Ranibizumab Ophthalmic

Drug

0.25mg/0.025 mL

Other names: Intravitreal

Primary outcomes

  1. To compare the serum VEGF concentrations after intravitreal application of Bevacizumab vs Ranibizumab

    Time frame: 6 months

    Evaluate the Serum VEGF concentration with the ELISA assay after intravitreal application of Bevacizumab or ranibizumab

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de San Luis Potosí

Other

Collaborators

  • Hospital Central "Dr. Ignacio Morones Prieto"

Registry information

Official study title

Comparison of the Vascular Endothelial Growth Factor Serum Concentrations After Intravitreal Use of Bevacizumab or Ranibizumab as a Treatment for Type 1 Retinopathy of Prematurity

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 10, 2017
Registry last updated
Jan 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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