Back to results

Antiangiogenic Therapy With Bevacizumab in Retinopathy of Prematurity. Structural Outcome

Primary Purpose

Retinopathy of Prematurity

Status

Unknown status

Phase

Phase 2

Locations

Mexico

Study Type

Interventional

Intervention

intravitreal injection

About this trial

This is an interventional treatment trial for Retinopathy of Prematurity focused on measuring Retinopathy of prematurity, antiangiogenic therapy

Eligibility Criteria

1 Month - 12 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Outcomes

Primary Outcome Measures

Clinical appearance

Secondary Outcome Measures

Full Information

NCT ID

NCT00346814

First Posted

June 29, 2006

Last Updated

June 28, 2009

Sponsor

Asociación para Evitar la Ceguera en México

1. Study Identification

Unique Protocol Identification Number

NCT00346814

Brief Title

Antiangiogenic Therapy With Bevacizumab in Retinopathy of Prematurity. Structural Outcome

Official Title

Antiangiogenic Therapy With Bevacizumab in Retinopathy of Prematurity. Structural Outcome

Study Type

Interventional

2. Study Status

Record Verification Date

June 2006

Overall Recruitment Status

Unknown status

Study Start Date

July 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2006 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Asociación para Evitar la Ceguera en México

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinopathy of Prematurity

Keywords

Retinopathy of prematurity, antiangiogenic therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

intravitreal injection

Primary Outcome Measure Information:

Title

Clinical appearance

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Month

Maximum Age & Unit of Time

12 Months

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hugo Quiroz-Mercado, MD

Phone

525510841400

Ext

1171

retinamex@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Maria A Martínez-Castellanos, MD

Phone

525510841400

Ext

1171

retinamex@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria Martínez-Castellanos, MD

Organizational Affiliation

Asociación para Evitar la Ceguera en México

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Mexico City

State/Province

Mexico DF

ZIP/Postal Code

04030

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria A Martinez-Castellanos, MD

Phone

525510841400

Ext

1171

retinamex@yahoo.com

First Name & Middle Initial & Last Name & Degree

Maria Martinez-Castellanos, MD

First Name & Middle Initial & Last Name & Degree

Hugo A Quiroz-Mercado, MD

First Name & Middle Initial & Last Name & Degree

Myriam L Hernandez-Rojas, MD

First Name & Middle Initial & Last Name & Degree

Jans Fromow-Guerra, MD

12. IPD Sharing Statement

Learn more about this trial

Antiangiogenic Therapy With Bevacizumab in Retinopathy of Prematurity. Structural Outcome

We'll reach out to this number within 24 hrs