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RecruitingNCT00346814Updated Jul 31, 2024

Antiangiogenic Therapy With Bevacizumab in Retinopathy of Prematurity. Structural Outcome

A Phase 2/3 interventional study of intravitreal injection in Retinopathy of Prematurity, sponsored by Asociación para Evitar la Ceguera en México. Recruiting at 1 site in Mexico. Open to participants aged 1 Month to 12 Months. Per ClinicalTrials.gov, last updated 2024-07-31.

Sponsored by Asociación para Evitar la Ceguera en México · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2007; still recruiting 19 years 4 months later.
Phase
Phase 2/3
Study type
Interventional
Allocation
Non-randomized
Ages
1 Month to 12 Months
Sex
All
01

Study 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

02

Conditions studied

  • Retinopathy of Prematurity

Keywords

  • Retinopathy of prematurity
  • antiangiogenic therapy
03

In context

Retinopathy of Prematurity

169 studies on the registry are indexed under Retinopathy of Prematurity; 27 are open to participants now.

Browse Retinopathy of Prematurity studies →

Lead sponsor

Asociación para Evitar la Ceguera en México is the lead sponsor of 60 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 12 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • PATIENTS THAT COULD BE TREATED WITH CRYOTHERAPY OR LASER
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)

Interventions

06

What researchers measure

Primary outcomes

  1. Clinical appearance

07

Study locations

1 of 1 sites recruiting
  • Asociación para Evitar la Ceguera en México Hospital "Luis Sanchez Bulnes"
    Mexico City, Mexico DF 04030, Mexico
    Recruiting
    • Maria A Martinez-Castellanos, MD · Contactretinamex@yahoo.com · 525510841400
    • Maria Martinez-Castellanos, MD · Principal investigator
    • Hugo A Quiroz-Mercado, MD · Sub investigator
    • Myriam L Hernandez-Rojas, MD · Sub investigator
    • Jans Fromow-Guerra, MD · Sub investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2007 to primary completion in Jul 2007, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 29, 2006
First posted
Jun 30, 2006
StartActual
Jul 2007
Primary completionActual
Jul 2007
CompletionEst.
Nov 2024
Last update
Jul 31, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00346814
Lead sponsor
Asociación para Evitar la Ceguera en México
Responsible party
Sponsor
First posted
Jun 30, 2006
Start date
Jul 2007
Primary completion
Jul 2007
Completion
Nov 2024 (estimated)
Last update
Jul 31, 2024

Study contacts

Hugo Quiroz-Mercado, MD
Contact
retinamex@yahoo.com
525510841400 ext. 1171
Maria A Martínez-Castellanos, MD
Contact
retinamex@yahoo.com
525510841400 ext. 1171
Maria Martínez-Castellanos, MD
principal investigator · Asociación para Evitar la Ceguera en México
View the source record on ClinicalTrials.gov ↗

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