Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03148132
Recruitment Status : Completed
First Posted : May 10, 2017
Last Update Posted : January 9, 2019
Sponsor:
Collaborator:
Hospital Central "Dr. Ignacio Morones Prieto"
Information provided by (Responsible Party):
Ada Gabriela Hernández Gámez, 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.


Condition or disease Intervention/treatment Phase
Retinopathy of Prematurity Both Eyes Retinal Disease Premature Birth Eye Diseases Drug: Bevacizumab Injection Drug: Ranibizumab Ophthalmic Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Group 1: Patients that fullfil type 1 ROP criteria that will be treated with Bevacizumab Group 2: Patients that fullfil type 1 ROP criteria that will be treated with Ranibizumab
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: The principal investigator and the outcomes assesor will be blinded, the assignation of the treatment will be randomized. The parents or tutor of the participant will be blinded
Primary Purpose: Other
Official 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
Actual Study Start Date : May 23, 2017
Actual Primary Completion Date : August 30, 2018
Actual Study Completion Date : August 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Bevacizumab injection
Application of Intravitreal Bevacizumab (0.50mg/0.02mL), unique dosis
Drug: Bevacizumab Injection
0.5mg/0.02 mL
Other Name: Intravitreal

Experimental: Ranibizumab Ophthalmic
Application of Intravitreal Ranibizumab (0.25mg/0.025mL), unique dosis
Drug: Ranibizumab Ophthalmic
0.25mg/0.025 mL
Other Name: Intravitreal




Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03148132


Locations
Layout table for location information
Mexico
Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosí, Mexico, 78170
Sponsors and Collaborators
Universidad Autonoma de San Luis Potosí
Hospital Central "Dr. Ignacio Morones Prieto"
Investigators
Layout table for investigator information
Study Director: Martha G Rangel, MD Hospital Central "Dr. Ignacio Morones Prieto"

Layout table for additonal information
Responsible Party: Ada Gabriela Hernández Gámez, MD, Universidad Autonoma de San Luis Potosí
ClinicalTrials.gov Identifier: NCT03148132     History of Changes
Other Study ID Numbers: 31-17
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ada Gabriela Hernández Gámez, Universidad Autonoma de San Luis Potosí:
Retinopathy of Prematurity
VEGF
Bevacizumab
Ranibizumab

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