Antiangiogenic Therapy With Bevacizumab in Retinopathy of Prematurity. Structural Outcome

NCT ID: NCT00346814

Last Updated: 2024-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2024-11-30

Brief Summary

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Purpose:Retinopathy of prematurity (ROP) continues tobe a major cause of blindness in children. Although ablation of the retina with laser or cryotherapy reduces the incidence of blindness by suppressing the neovascular phase of ROP the visual outcomes after treatment are often poor. Vascular endothelial growth factor(VEGF) has an important role in the pathogenesis of ROP and inhibition of VEGF expression in the neovascular phase might prevent destructive neovascularization in ROP. The aim of this study is to determine the safety and efficacy of intravitreal bevacizumab in the treatment of retinopathy of prematurity

Detailed Description

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Conditions

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Retinopathy of Prematurity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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intravitreal injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Retinopathy of prematurity stages III, IV and V in which we can not treat with laser o cryotherAPY

Exclusion Criteria

* PATIENTS THAT COULD BE TREATED WITH CRYOTHERAPY OR LASER
Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asociación para Evitar la Ceguera en México

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Martínez-Castellanos, MD

Role: PRINCIPAL_INVESTIGATOR

Asociación para Evitar la Ceguera en México

Locations

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Asociación para Evitar la Ceguera en México Hospital "Luis Sanchez Bulnes"

Mexico City, Mexico DF, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Hugo Quiroz-Mercado, MD

Role: CONTACT

525510841400 ext. 1171

Maria A Martínez-Castellanos, MD

Role: CONTACT

525510841400 ext. 1171

Facility Contacts

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Maria A Martinez-Castellanos, MD

Role: primary

525510841400 ext. 1171

Other Identifiers

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APEC-001

Identifier Type: -

Identifier Source: org_study_id

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