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
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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|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|
|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|
Active Comparator: Bevacizumab injection
Application of Intravitreal Bevacizumab (0.50mg/0.02mL), unique dosis
Drug: Bevacizumab Injection
Other Name: Intravitreal
Experimental: Ranibizumab Ophthalmic
Application of Intravitreal Ranibizumab (0.25mg/0.025mL), unique dosis
Drug: Ranibizumab Ophthalmic
Other Name: Intravitreal
- 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
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
|Hospital Central "Dr. Ignacio Morones Prieto"|
|San Luis Potosí, Mexico, 78170|
|Study Director:||Martha G Rangel, MD||Hospital Central "Dr. Ignacio Morones Prieto"|