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

Phase 4

Completed

• Conditions: Retinal Disease; Eye Diseases; Retinopathy of Prematurity Both Eyes; Premature Birth
• Interventions: Drug: Bevacizumab Injection; Drug: Ranibizumab Ophthalmic

• Registration Number: NCT03148132
• Lead Sponsor: Universidad Autonoma de San Luis Potosí

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-05-08
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-10
• Study Start: 2017-05-23
• Primary Completion: 2018-08-30
• Study Completion: 2018-08-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

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

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Exclusion Criteria

• Patients that do not continue the required evaluations.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bevacizumab injection	Bevacizumab Injection	Application of Intravitreal Bevacizumab (0.50mg/0.02mL), unique dosis
Ranibizumab Ophthalmic	Ranibizumab Ophthalmic	Application of Intravitreal Ranibizumab (0.25mg/0.025mL), unique dosis

Primary Outcome Measures

Name	Time	Method
To compare the serum VEGF concentrations after intravitreal application of Bevacizumab vs Ranibizumab	6 months	Evaluate the Serum VEGF concentration with the ELISA assay after intravitreal application of Bevacizumab or ranibizumab

Trial Locations

Locations (1)

Hospital Central "Dr. Ignacio Morones Prieto"; 🇲🇽 San Luis Potosí, Mexico