Antiangiogenic Therapy With Bevacizumab in Retinopathy of... | NCT00346814

Studies
Antiangiogenic Therapy With Bevacizumab in Retinopathy of Prematurity. Structural Outcome

NCT00346814

Sponsor

Asociación para Evitar la Ceguera en México

Status

Recruiting

Last Update Posted

Jul 31, 2024Actual

Enrollment

Not provided

Phase

Phase 2Phase 3

Conditions

Retinopathy of Prematurity

Interventions

intravitreal injection

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007Actual

Primary Completion Date

Jul 2007Actual

Completion Date

Nov 2024Estimated

First Submitted Date

Jun 29, 2006

First Submission Date that Met QC Criteria

Jun 29, 2006

First Posted Date

Jun 30, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2024

Last Update Posted Date

Jul 31, 2024Actual

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
intravitreal injection	Drug

Measure	Description	Time Frame
Clinical appearance

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

12 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hugo Quiroz-Mercado, MD	Contact	525510841400	1171	retinamex@yahoo.com
Maria A Martínez-Castellanos, MD	Contact	525510841400	1171	retinamex@yahoo.com

Overall Officials

Name	Affiliation	Role
Maria Martínez-Castellanos, MD	Asociación para Evitar la Ceguera en México	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asociación para Evitar la Ceguera en México Hospital "Luis Sanchez Bulnes"	Recruiting	Mexico City	Mexico DF	04030	Mexico

Condition Browse Module

MeSH Terms

ID	Term
D012178	Retinopathy of Prematurity

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D007235	Infant, Premature, Diseases
D007232	Infant, Newborn, Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D058449	Intravitreal Injections

Ancestor Terms

ID	Term
D056965	Injections, Intraocular
D007267	Injections
D004333	Drug Administration Routes
D004358	Drug Therapy

Browse Leaves

Not provided

Browse Branches

Not provided