NCT00346814

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

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

June 29, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2006

Completed
1 year until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
17.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

Same day

First QC Date

June 29, 2006

Last Update Submit

July 30, 2024

Conditions

Retinopathy of Prematurity

Keywords

Retinopathy of prematurityantiangiogenic therapy

Outcome Measures

Primary Outcomes (1)

  • Clinical appearance

Interventions

intravitreal injectionDRUG

Eligibility Criteria

Age1 Month - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • PATIENTS THAT COULD BE TREATED WITH CRYOTHERAPY OR LASER

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Mexico City, Mexico DF, 04030, Mexico

RECRUITING

MeSH Terms

Conditions

Retinopathy of Prematurity

Interventions

Intravitreal Injections

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Injections, IntraocularInjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Maria Martínez-Castellanos, MD

    Asociación para Evitar la Ceguera en México

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hugo Quiroz-Mercado, MD

CONTACT

525510841400retinamex@yahoo.com

Maria A Martínez-Castellanos, MD

CONTACT

525510841400retinamex@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2006

First Posted

June 30, 2006

Study Start

July 1, 2007

Primary Completion

July 1, 2007

Study Completion

November 1, 2024

Last Updated

July 31, 2024

Record last verified: 2024-07

Locations

ME(1)