Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-03-19 @ 10:34 PM
Study NCT ID:
NCT03148132
Status:
COMPLETED
Last Update Posted:
2019-01-09
First Post:
2017-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VEGF Concentrations After Intravitreal Bevacizumab vs Ranibizumab as a Treatment for Type 1 ROP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012178', 'term': 'Retinopathy of Prematurity'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D058449', 'term': 'Intravitreal Injections'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D056965', 'term': 'Injections, Intraocular'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-08', 'studyFirstSubmitDate': '2017-05-08', 'studyFirstSubmitQcDate': '2017-05-09', 'lastUpdatePostDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the serum VEGF concentrations after intravitreal application of Bevacizumab vs Ranibizumab', 'timeFrame': '6 months', 'description': 'Evaluate the Serum VEGF concentration with the ELISA assay after intravitreal application of Bevacizumab or ranibizumab'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Retinopathy of Prematurity', 'VEGF', 'Bevacizumab', 'Ranibizumab'], 'conditions': ['Retinopathy of Prematurity Both Eyes', 'Retinal Disease', 'Premature Birth', 'Eye Diseases']}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.\n\nThe treatment is begun on patient with type 1 ROP and type 2 ROP is maintained in observation.", 'detailedDescription': "It has been documented that de Vascular Endothelial Growth Factor (VEGF) is involved on the physiopathology of this disease.\n\nThe 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.\n\nNowadays 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.\n\nHowever these drugs can pass through the hematorretinal barrier in to the blood stream where they can also decrease the systemic levels of VEGF.\n\nWe still don't know the long term effects of the intravitreal application of these drugs on premature babies, but there is the concern.\n\nThe 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.\n\nHYPOTESIS: The serum VEGF concentrations after the intravitreal application of Bevacizumab will be smaller than the serum VEGF concentrations after the intravitreal application of Ranibizumab.\n\nMETHODOLOGY: Safety ECCA. Inclusion criteria, premature newborns who fulfill the criteria for type 1 ROP according to the ET-ROP classification.\n\nThe 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).\n\nThe 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.\n\nThe analysis will be performed by ELISA kits.\n\nThe investigators are going to describe the results of the ELISA for the blood samples, and then make a comparison between both groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'minimumAge': '28 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Premature newborns that fulfill the criteria for type 1 ROP, according to the Early Treatment of ROP classification on both eyes.\n\nExclusion Criteria:\n\n* Patients that do not continue the required evaluations.'}, 'identificationModule': {'nctId': 'NCT03148132', 'briefTitle': 'VEGF Concentrations After Intravitreal Bevacizumab vs Ranibizumab as a Treatment for Type 1 ROP', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Autonoma de San Luis Potosí'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '31-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bevacizumab injection', 'description': 'Application of Intravitreal Bevacizumab (0.50mg/0.02mL), unique dosis', 'interventionNames': ['Drug: Bevacizumab Injection']}, {'type': 'EXPERIMENTAL', 'label': 'Ranibizumab Ophthalmic', 'description': 'Application of Intravitreal Ranibizumab (0.25mg/0.025mL), unique dosis', 'interventionNames': ['Drug: Ranibizumab Ophthalmic']}], 'interventions': [{'name': 'Bevacizumab Injection', 'type': 'DRUG', 'otherNames': ['Intravitreal'], 'description': '0.5mg/0.02 mL', 'armGroupLabels': ['Bevacizumab injection']}, {'name': 'Ranibizumab Ophthalmic', 'type': 'DRUG', 'otherNames': ['Intravitreal'], 'description': '0.25mg/0.025 mL', 'armGroupLabels': ['Ranibizumab Ophthalmic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78170', 'city': 'San Luis Potosí City', 'country': 'Mexico', 'facility': 'Hospital Central "Dr. Ignacio Morones Prieto"', 'geoPoint': {'lat': 22.15234, 'lon': -100.97135}}], 'overallOfficials': [{'name': 'Martha G Rangel, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Central "Dr. Ignacio Morones Prieto"'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Autonoma de San Luis Potosí', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Central "Dr. Ignacio Morones Prieto"', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Ada Gabriela Hernández Gámez', 'investigatorAffiliation': 'Universidad Autonoma de San Luis Potosí'}}}}