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

NCT03148132 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-01-09

No results posted yet for this study

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.

Conditions

  • Retinopathy of Prematurity Both Eyes
  • Retinal Disease
  • Premature Birth
  • Eye Diseases

Interventions

DRUG

Bevacizumab Injection

0.5mg/0.02 mL

DRUG

Ranibizumab Ophthalmic

0.25mg/0.025 mL

Sponsors & Collaborators

  • Hospital Central "Dr. Ignacio Morones Prieto"

    collaborator OTHER

  • Universidad Autonoma de San Luis Potosí

    lead OTHER

Principal Investigators

  • Martha G Rangel, MD · Hospital Central "Dr. Ignacio Morones Prieto"

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
28 Days
Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-23
Primary Completion
2018-08-30
Completion
2018-08-30

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03148132 on ClinicalTrials.gov