VEGF Concentrations After Intravitreal Bevacizumab vs Ranibizumab as a Treatment for Type 1 ROP
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
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2017
CompletedFirst Posted
Study publicly available on registry
May 10, 2017
CompletedStudy Start
First participant enrolled
May 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2018
CompletedJanuary 9, 2019
January 1, 2019
1.3 years
May 8, 2017
January 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare the serum VEGF concentrations after intravitreal application of Bevacizumab vs Ranibizumab
Evaluate the Serum VEGF concentration with the ELISA assay after intravitreal application of Bevacizumab or ranibizumab
6 months
Study Arms (2)
Bevacizumab injection
ACTIVE COMPARATORApplication of Intravitreal Bevacizumab (0.50mg/0.02mL), unique dosis
Ranibizumab Ophthalmic
EXPERIMENTALApplication of Intravitreal Ranibizumab (0.25mg/0.025mL), unique dosis
Interventions
Eligibility Criteria
You may qualify if:
- Premature newborns that fulfill the criteria for type 1 ROP, according to the Early Treatment of ROP classification on both eyes.
You may not qualify if:
- Patients that do not continue the required evaluations.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosí City, 78170, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Martha G Rangel, MD
Hospital Central "Dr. Ignacio Morones Prieto"
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 8, 2017
First Posted
May 10, 2017
Study Start
May 23, 2017
Primary Completion
August 30, 2018
Study Completion
August 30, 2018
Last Updated
January 9, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share